Skip to content

Pilot Study of Losartan and N-acetylcysteine as Inhibitors of Muscle Oxidative Stress in Elderly

Pilot Study of Losartan and N-acetylcysteine as Inhibitors of Muscle Oxidative Stress in Elderly

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01384591
Enrollment
6
Registered
2011-06-29
Start date
2011-07-31
Completion date
2015-05-31
Last updated
2018-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging

Keywords

oxidative stress, blood flow, antioxidant, muscle, elderly

Brief summary

The general hypothesis is that elderly have diminished nutritive flow to skeletal muscle and impaired capacity for building muscle. In aging populations, this decreased ability to build muscle may represent a tipping point in the progression towards chronic physical frailty and disability. The goal is to examine whether novel pharmacologic therapies can improve nutritive blood flow to the muscles and muscle building in the elderly. The purpose of this study is 1) to determine if losartan administration will enhance blood flow and 2) to determine if N-acetylcysteine (NAC) will enhance blood flow. The investigators will study community dwelling, healthy older men and women (60-85 years). Subjects will be randomized to one of three groups: Experimental Group 1: Placebo losartan and placebo N-acetylcysteine (NAC). Experimental Group 2: losartan (25mg/dose) and placebo N-acetylcysteine (NAC). Experimental Group 3: N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo Subjects will admit to the clinic on day 1 of the study. Baseline testing consisting of leg blood flow (LBF), contrast enhanced ultrasound, handgrip testing and fatigue questionnaires. After testing is completed the subjects will recieve their first dose of NAC/ losartan/ placebo with dinner. Subjects will be fasted after 10 pm. On day 2, leg blood flow (LBF) will be measured approximately 12 hours post dose 1. Subjects will receive their second dose of NAC/ losartan/ placebo. Leg blood flow will be measured 1 hour and 2 hours post dose 2 of study interventions. The subjects will eat a meal and receive their third dose of the study intervention. Leg blood flow will be repeated at 1 hour and 2 hours post dose 3. Appoximately 30 minutes after dose 3 of the study intervention, handgrip testing will be performed and fatigue questionnaires completed.

Interventions

DRUGN-acetylcysteine

50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.

DRUGLosartan

25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.

DRUGPlacebo losartan

Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.

DRUGPlacebo N-acetylcysteine

Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.

Sponsors

Lantheus Medical Imaging
CollaboratorINDUSTRY
The University of Texas Medical Branch, Galveston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

1. Age between 60-85 years. 2. Ability to sign informed consent. 3. Ability to sign consent form. 4. Ability to pass a mini-mental status exam (score \>23 on the 30-item Mini Mental State Examination, MMSE). 5. Free-living, prior to admission.

Exclusion criteria

1. Subjects with cardiac abnormalities considered exclusionary by the study physicians (e.g., unstable angina or a cardiology-confirmed ECG that demonstrates cardiac abnormalities such as \> 0.2 mV horizontal or downsloping ST segment depression, frequent arrhythmia's (\> 10 PVC/min), or valvular disease). 2. Subjects with uncontrolled metabolic disease, including liver or renal disease. 3. Subjects with vascular disease characterized by a combination of risk factors of peripheral atherosclerosis. (e.g., uncontrolled hypertension, obesity, uncontrolled diabetes, hypercholesterolemia \> 250 mg/dl, claudication or evidence of venous or arterial insufficiency upon palpitation of femoral, popliteal, and pedal arteries. 4. Any history of hypo- or hyper-coagulation disorders. (e.g., Coumadin use or history of DVT or PE). 5. Subjects with chronically elevated systolic pressure \>170 or a diastolic blood pressure \> 100. Subjects may be included if they are taking medication and have a blood pressure below these criteria. 6. Subjects with cancer or recently (6 months) treated cancer other than basal cell carcinoma. 7. Any subject currently on a weight-loss diet or a body mass index \> 33 kg/m2. 8. Inability to abstain from smoking for duration of study. 9. A history of \> 20 pack per year smoking. 10. Subjects with atrial fibrillation, history of syncope, angina, or congestive heart failure. 11. Any subject that is HIV-seropositive or has active hepatitis. 12. Recent anabolic or corticosteroids use (within 3 months). 13. Subjects with low hemoglobin or hematocrit (i.e., lower than accepted lab values). 14. Agitation/aggression disorder. 15. Dementia. 16. History of stroke with motor disability. 17. A recent history (\<12 months) of GI bleed. 18. Alcohol (more than 3 drinks per day) or drug abuse. 19. Polycystic ovary syndrome (PCOS) and/or hyperthecosis. 20. Non-classical adrenal hyperplasia. 21. Cushing's syndrome. 22. Pregnancy. 23. Hyperprolactinoma, hypothyroidism. 24. Lactose intolerance. 25. Subjects with coronary heart or mitral valvular rheumatic heart disease. 26. Subjects with impaired renal function and/or renal artery stenosis. 27. Subjects with pulmonary hypertension. 28. Subjects on any medications known to vasodilate the peripheral arteries. 29. Subjects taking NSAIDs 30. Physical dependence or frailty (impairment of activities of daily living, ADLs). 31. History of falls (\>2/year). 32. Depression (\>5 of the 15 items on the Geriatric Depression Scale (GDS). 33. Subjects suffering malnutrition or with a BMI \< 20 kg/m2 with low albumin or transferrin. 34. Asthma 35. Any other condition or event considered exclusionary by the PI and covering faculty physician.

Design outcomes

Primary

MeasureTime frameDescription
Leg Blood Flow as Measured by Doppler UltrasoundBaselineFemoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.

Secondary

MeasureTime frameDescription
Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort at BaselinebaselineHandgrip Strength of non-dominant hand is measured by handgrip dynamometry at 50% perceived effort with subjects performing one set of three contractions.
Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 100% Effort at BaselinebaselineHandgrip Strength of dominant hand is measured by handgrip dynamometry at 100% effort with subjects performing one set of three contractions.
Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 100% Effort at BaselinebaselineHandgrip Strength of non-dominant hand is measured by handgrip dynamometry at 100% effort with subjects performing one set of three contractions.
Handgrip Fatigue of Dominant Hand as Measured by Handgrip Dynamometry at BaselinebaselineHandgrip fatigue of dominant hand as measured by handgrip dynamometry fatigue test. The non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Data is reported as % of Maximal Voluntary Contraction after fatigue test.
Handgrip Fatigue of Non-dominant Hand as Measured by Handgrip Dynamometry at BaselinebaselineHandgrip fatigue of non-dominant hand as measured by handgrip dynamometry fatigue test. The non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Data is reported as % of Maximal Voluntary Contraction (MVC) after fatigue test.
Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort After All Doses of Study InterventionPost dose three of the intervention, average of 17 hours post dose one interventionHandgrip Strength of dominant hand is measured by handgrip dynamometry at 50% perceived effort with subjects performing one set of three contractions.
Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort After All Doses of Study InterventionPost dose three of the intervention, average of 17 hours post dose one interventionHandgrip Strength of non-dominant hand is measured by handgrip dynamometry at 50% perceived effort with subjects performing one set of three contractions.
Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 100% Perceived Effort After All Doses of Study InterventionPost dose three of the intervention, average of 17 hours post dose one interventionHandgrip Strength of dominant hand is measured by handgrip dynamometry at 100% perceived effort with subjects performing one set of three contractions.
Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 100% Perceived Effort After All Doses of Study InterventionPost dose three of the intervention, average of 17 hours post dose one interventionHandgrip Strength of non-dominant hand is measured by handgrip dynamometry at 100% perceived effort with subjects performing one set of three contractions.
Handgrip Fatigue of Dominant Hand as Measured by Handgrip Dynamometry After All Doses of Study InterventionPost dose three of the intervention, average of 17 hours post dose one interventionHandgrip fatigue of dominant hand as measured by handgrip dynamometry fatigue test. The non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Data reported as % of Maximal Voluntary Contraction (MVC) after fatigue test.
Handgrip Fatigue of Non-dominant Hand as Measured by Handgrip Dynamometry After All Doses of Study InterventionPost dose three of the intervention, average of 17 hours post dose one interventionHandgrip fatigue of non-dominant hand as measured by handgrip dynamometry fatigue test. The non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Data reported as % of Maximal Voluntary Contraction (MVC) after fatigue test.
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale General Fatigue at BaselineBaselineMultidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the general fatigue scale is 24 to 0, with the higher number meaning more fatigue. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale General Fatigue After All Doses of Study InterventionPost dose three of the intervention, average of 17 hours post dose one interventionMultidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the general fatigue scale is 24 to 0, with the higher number meaning more fatigue. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Physical Fatigue at BaselineBaselineMultidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the physical fatigue scale is 24 to 0, with the higher number meaning more fatigue. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Physical Fatigue After All Doses of Study InterventionPost dose three of the intervention, average of 17 hours post dose one interventionMultidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the physical fatigue scale is 24 to 0, with the higher number meaning more fatigue. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Emotional Fatigue at BaselineBaselineMultidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the emotional fatigue scale is 24 to 0, with the higher number meaning more fatigue. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort at BaselinebaselineHandgrip Strength of dominant hand is measured by handgrip dynamometry at 50% perceived effort with subjects performing one set of three contractions.
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Mental Fatigue at BaselineBaselineMultidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the mental fatigue scale is 24 to 0, with the higher number meaning more fatigue. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Mental Fatigue After All Doses of Study InterventionPost dose three of the intervention, average of 17 hours post dose one interventionMultidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the mental fatigue scale is 24 to 0, with the higher number meaning more fatigue The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Vigor Fatigue at BaselineBaselineMultidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the vigor scale is 0 to 24, with the higher number meaning more vigor. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Vigor Fatigue After All Doses of Study InterventionPost dose three of the intervention, average of 17 hours post dose one interventionMultidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the vigor scale is 0 to 24, with the higher number meaning more vigor. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Total Score at BaselineBaselineMultidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Total Score After All Doses of Study InterventionPost dose three of the intervention, average of 17 hours post dose one interventionMultidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
Global Fatigue Score as Measured by Brief Fatigue Inventory at BaselineBaselineThe Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with 0 being no fatigue and 10 being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. Score ranges (0 to 10) with higher score indicating a worse outcome.
Global Fatigue Score as Measured by Brief Fatigue Inventory After Study InventionPost dose three of the intervention, average of 17 hours post dose one interventionThe Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with 0 being no fatigue and 10 being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. Score range 0 to 10, with a higher score indicating a worse outcome.
Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale Before Handgrip Fatigue Test at Baseline.baseline - before handgrip fatigue testThe Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention.
Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale After Handgrip Fatigue Test at Baseline.baseline - directly after handgrip fatigue testThe Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention.
Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale Before Handgrip Fatigue Test After Study InterventionPost dose three of the intervention, average of 17 hours post dose one intervention - Before handgrip fatigue testThe Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention.
Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale After Handgrip Fatigue Test After Study InterventionPost dose three of the intervention, average of 17 hours post dose one intervention - Directly after handgrip fatigue testThe Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention.
Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale Before Handgrip Fatigue Test at Baseline.baseline - before handgrip fatigue testThe Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention.
Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale After Handgrip Fatigue Test at Baseline.baseline - directly after handgrip fatigue testThe Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention.
Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale Before Handgrip Fatigue Test After Study InterventionPost dose three of the intervention, average of 17 hours post dose one intervention - Before handgrip fatigue testThe Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention.
Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale After Handgrip Fatigue Test After Study InterventionPost dose three of the intervention, average of 17 hours post dose one intervention - Directly after handgrip fatigue testThe Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention.
Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Emotional Fatigue After All Doses of Study InterventionPost dose three of the intervention, average of 17 hours post dose one interventionMultidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the emotional fatigue scale is 24 to 0, with the higher number meaning more fatigue. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.

Countries

United States

Participant flow

Participants by arm

ArmCount
Losartan and Placebo N-acetylcysteine
losartan (25mg/dose) and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2. Losartan: 25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2. Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
2
Placebo Losartan and Placebo N-acetylcysteine
Placebo losartan and placebo N-acetylcysteine (NAC) 3 total doses: 1 dose on day 1, 2 doses on day 2. Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2. Placebo N-acetylcysteine: Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
2
N-acetylcysteine and Placebo Losartan
N-acetylcysteine (NAC) (50 mg/kg/dose) and placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2. N-acetylcysteine: 50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2. Placebo losartan: Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
2
Total6

Baseline characteristics

CharacteristicLosartan and Placebo N-acetylcysteinePlacebo Losartan and Placebo N-acetylcysteineN-acetylcysteine and Placebo LosartanTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
2 Participants2 Participants2 Participants6 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants
Age, Continuous75.2 years
STANDARD_DEVIATION 3.6
72.3 years
STANDARD_DEVIATION 2.1
68.5 years
STANDARD_DEVIATION 1.3
72 years
STANDARD_DEVIATION 3.6
Fat Mass23.7 kilograms
STANDARD_DEVIATION 0.98
16.6 kilograms
STANDARD_DEVIATION 3.2
16.8 kilograms
STANDARD_DEVIATION 0.49
19.1 kilograms
STANDARD_DEVIATION 3.9
Lean Body Mass41.2 kilograms
STANDARD_DEVIATION 11.1
52.9 kilograms
STANDARD_DEVIATION 14.2
45.9 kilograms
STANDARD_DEVIATION 2.4
46.7 kilograms
STANDARD_DEVIATION 9.7
Region of Enrollment
United States
2 Participants2 Participants2 Participants6 Participants
Sex: Female, Male
Female
1 Participants0 Participants0 Participants1 Participants
Sex: Female, Male
Male
1 Participants2 Participants2 Participants5 Participants
Total Mass67.1 kilograms
STANDARD_DEVIATION 10.2
72.7 kilograms
STANDARD_DEVIATION 11.4
65.7 kilograms
STANDARD_DEVIATION 3.5
68.5 kilograms
STANDARD_DEVIATION 7.8

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 20 / 20 / 2
other
Total, other adverse events
1 / 20 / 20 / 2
serious
Total, serious adverse events
0 / 20 / 20 / 2

Outcome results

Primary

Leg Blood Flow as Measured by Doppler Ultrasound

Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteineLeg Blood Flow as Measured by Doppler Ultrasound174.99 ml/minuteStandard Deviation 176.02
N-acetylcysteine and Placebo LosartanLeg Blood Flow as Measured by Doppler Ultrasound102.08 ml/minuteStandard Deviation 3.42
Losartan and Placebo N-acetylcysteineLeg Blood Flow as Measured by Doppler Ultrasound428.45 ml/minuteStandard Deviation 114.57
Primary

Leg Blood Flow as Measured by Doppler Ultrasound

Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.

Time frame: 12 hours post dose one of the intervention

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteineLeg Blood Flow as Measured by Doppler Ultrasound181.88 ml/minuteStandard Deviation 204.92
N-acetylcysteine and Placebo LosartanLeg Blood Flow as Measured by Doppler Ultrasound69.83 ml/minuteStandard Deviation 77.57
Losartan and Placebo N-acetylcysteineLeg Blood Flow as Measured by Doppler Ultrasound91.68 ml/minuteStandard Deviation 4.88
Primary

Leg Blood Flow as Measured by Doppler Ultrasound

Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.

Time frame: 1 hour post dose two of the intervention, average of 13 hours post dose 1 of the intervention

Population: Missed blood flow measurement on one placebo participant at this time point.

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteineLeg Blood Flow as Measured by Doppler Ultrasound105.80 ml/minute
N-acetylcysteine and Placebo LosartanLeg Blood Flow as Measured by Doppler Ultrasound90.06 ml/minuteStandard Deviation 39.19
Losartan and Placebo N-acetylcysteineLeg Blood Flow as Measured by Doppler Ultrasound95.60 ml/minuteStandard Deviation 64.67
Primary

Leg Blood Flow as Measured by Doppler Ultrasound

Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.

Time frame: 2 hours post dose two of the intervention, average of 14 hours post dose one of the intervention

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteineLeg Blood Flow as Measured by Doppler Ultrasound214.56 ml/minuteStandard Deviation 88.42
N-acetylcysteine and Placebo LosartanLeg Blood Flow as Measured by Doppler Ultrasound70.37 ml/minuteStandard Deviation 15.35
Losartan and Placebo N-acetylcysteineLeg Blood Flow as Measured by Doppler Ultrasound114.34 ml/minuteStandard Deviation 38.71
Primary

Leg Blood Flow as Measured by Doppler Ultrasound

Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.

Time frame: Post dose three of the intervention and a meal, average of 17 hours post dose one of the intervention

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteineLeg Blood Flow as Measured by Doppler Ultrasound158.71 ml/minuteStandard Deviation 83.85
N-acetylcysteine and Placebo LosartanLeg Blood Flow as Measured by Doppler Ultrasound109.94 ml/minuteStandard Deviation 59.51
Losartan and Placebo N-acetylcysteineLeg Blood Flow as Measured by Doppler Ultrasound153.38 ml/minuteStandard Deviation 103.37
Primary

Leg Blood Flow as Measured by Doppler Ultrasound

Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.

Time frame: 1 hour post dose three of the intervention and a meal, average of 18 hours post dose one of the intervention

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteineLeg Blood Flow as Measured by Doppler Ultrasound84.41 ml/minuteStandard Deviation 18.57
N-acetylcysteine and Placebo LosartanLeg Blood Flow as Measured by Doppler Ultrasound104.40 ml/minuteStandard Deviation 56.55
Losartan and Placebo N-acetylcysteineLeg Blood Flow as Measured by Doppler Ultrasound152.10 ml/minuteStandard Deviation 46.59
Primary

Leg Blood Flow as Measured by Doppler Ultrasound

Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.

Time frame: 2 hours post dose three of the intervention and a meal, average of 19 hours post dose one of the intervention

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteineLeg Blood Flow as Measured by Doppler Ultrasound70.60 ml/minuteStandard Deviation 17.46
N-acetylcysteine and Placebo LosartanLeg Blood Flow as Measured by Doppler Ultrasound128.78 ml/minuteStandard Deviation 123.74
Losartan and Placebo N-acetylcysteineLeg Blood Flow as Measured by Doppler Ultrasound57.79 ml/minuteStandard Deviation 29.24
Secondary

Global Fatigue Score as Measured by Brief Fatigue Inventory After Study Invention

The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with 0 being no fatigue and 10 being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. Score range 0 to 10, with a higher score indicating a worse outcome.

Time frame: Post dose three of the intervention, average of 17 hours post dose one intervention

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteineGlobal Fatigue Score as Measured by Brief Fatigue Inventory After Study Invention0.5 units on a scaleStandard Deviation 0.7
N-acetylcysteine and Placebo LosartanGlobal Fatigue Score as Measured by Brief Fatigue Inventory After Study Invention0.22 units on a scaleStandard Deviation 0.31
Losartan and Placebo N-acetylcysteineGlobal Fatigue Score as Measured by Brief Fatigue Inventory After Study Invention1.19 units on a scaleStandard Deviation 0.43
Secondary

Global Fatigue Score as Measured by Brief Fatigue Inventory at Baseline

The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with 0 being no fatigue and 10 being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. Score ranges (0 to 10) with higher score indicating a worse outcome.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteineGlobal Fatigue Score as Measured by Brief Fatigue Inventory at Baseline0.55 units on a scaleStandard Deviation 0.78
N-acetylcysteine and Placebo LosartanGlobal Fatigue Score as Measured by Brief Fatigue Inventory at Baseline0.38 units on a scaleStandard Deviation 0.39
Losartan and Placebo N-acetylcysteineGlobal Fatigue Score as Measured by Brief Fatigue Inventory at Baseline1.11 units on a scaleStandard Deviation 0.16
Secondary

Handgrip Fatigue of Dominant Hand as Measured by Handgrip Dynamometry After All Doses of Study Intervention

Handgrip fatigue of dominant hand as measured by handgrip dynamometry fatigue test. The non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Data reported as % of Maximal Voluntary Contraction (MVC) after fatigue test.

Time frame: Post dose three of the intervention, average of 17 hours post dose one intervention

Population: Data for 2 subjects not recorded.

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteineHandgrip Fatigue of Dominant Hand as Measured by Handgrip Dynamometry After All Doses of Study Intervention101.0 % of Maximal Voluntary Contraction
N-acetylcysteine and Placebo LosartanHandgrip Fatigue of Dominant Hand as Measured by Handgrip Dynamometry After All Doses of Study Intervention95.97 % of Maximal Voluntary ContractionStandard Deviation 2.16
Losartan and Placebo N-acetylcysteineHandgrip Fatigue of Dominant Hand as Measured by Handgrip Dynamometry After All Doses of Study Intervention111 % of Maximal Voluntary Contraction
Secondary

Handgrip Fatigue of Dominant Hand as Measured by Handgrip Dynamometry at Baseline

Handgrip fatigue of dominant hand as measured by handgrip dynamometry fatigue test. The non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Data is reported as % of Maximal Voluntary Contraction after fatigue test.

Time frame: baseline

Population: Data for 2 subjects wasn't recorded.

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteineHandgrip Fatigue of Dominant Hand as Measured by Handgrip Dynamometry at Baseline129.6 % of Maximal Voluntary Contraction
N-acetylcysteine and Placebo LosartanHandgrip Fatigue of Dominant Hand as Measured by Handgrip Dynamometry at Baseline94.2 % of Maximal Voluntary ContractionStandard Deviation 12.06
Losartan and Placebo N-acetylcysteineHandgrip Fatigue of Dominant Hand as Measured by Handgrip Dynamometry at Baseline103.4 % of Maximal Voluntary Contraction
Secondary

Handgrip Fatigue of Non-dominant Hand as Measured by Handgrip Dynamometry After All Doses of Study Intervention

Handgrip fatigue of non-dominant hand as measured by handgrip dynamometry fatigue test. The non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Data reported as % of Maximal Voluntary Contraction (MVC) after fatigue test.

Time frame: Post dose three of the intervention, average of 17 hours post dose one intervention

Population: Data from 2 subjects was not recorded.

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteineHandgrip Fatigue of Non-dominant Hand as Measured by Handgrip Dynamometry After All Doses of Study Intervention88.61 % of Maximal Voluntary Contraction
N-acetylcysteine and Placebo LosartanHandgrip Fatigue of Non-dominant Hand as Measured by Handgrip Dynamometry After All Doses of Study Intervention93.25 % of Maximal Voluntary ContractionStandard Deviation 11.32
Losartan and Placebo N-acetylcysteineHandgrip Fatigue of Non-dominant Hand as Measured by Handgrip Dynamometry After All Doses of Study Intervention95.60 % of Maximal Voluntary Contraction
Secondary

Handgrip Fatigue of Non-dominant Hand as Measured by Handgrip Dynamometry at Baseline

Handgrip fatigue of non-dominant hand as measured by handgrip dynamometry fatigue test. The non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Data is reported as % of Maximal Voluntary Contraction (MVC) after fatigue test.

Time frame: baseline

Population: Data for 2 subjects was not recorded.

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteineHandgrip Fatigue of Non-dominant Hand as Measured by Handgrip Dynamometry at Baseline64.55 % of Maximal Voluntary Contraction
N-acetylcysteine and Placebo LosartanHandgrip Fatigue of Non-dominant Hand as Measured by Handgrip Dynamometry at Baseline83.62 % of Maximal Voluntary ContractionStandard Deviation 2.33
Losartan and Placebo N-acetylcysteineHandgrip Fatigue of Non-dominant Hand as Measured by Handgrip Dynamometry at Baseline90.29 % of Maximal Voluntary Contraction
Secondary

Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 100% Effort at Baseline

Handgrip Strength of dominant hand is measured by handgrip dynamometry at 100% effort with subjects performing one set of three contractions.

Time frame: baseline

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteineHandgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 100% Effort at Baseline45.2 kilogramsStandard Deviation 8.2
N-acetylcysteine and Placebo LosartanHandgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 100% Effort at Baseline33.2 kilogramsStandard Deviation 4
Losartan and Placebo N-acetylcysteineHandgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 100% Effort at Baseline28.8 kilogramsStandard Deviation 13.9
Secondary

Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 100% Perceived Effort After All Doses of Study Intervention

Handgrip Strength of dominant hand is measured by handgrip dynamometry at 100% perceived effort with subjects performing one set of three contractions.

Time frame: Post dose three of the intervention, average of 17 hours post dose one intervention

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteineHandgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 100% Perceived Effort After All Doses of Study Intervention44.1 kilogramsStandard Deviation 6.2
N-acetylcysteine and Placebo LosartanHandgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 100% Perceived Effort After All Doses of Study Intervention31.3 kilogramsStandard Deviation 6.6
Losartan and Placebo N-acetylcysteineHandgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 100% Perceived Effort After All Doses of Study Intervention24.2 kilogramsStandard Deviation 13
Secondary

Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort After All Doses of Study Intervention

Handgrip Strength of dominant hand is measured by handgrip dynamometry at 50% perceived effort with subjects performing one set of three contractions.

Time frame: Post dose three of the intervention, average of 17 hours post dose one intervention

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteineHandgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort After All Doses of Study Intervention21.2 kilogramsStandard Deviation 13.9
N-acetylcysteine and Placebo LosartanHandgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort After All Doses of Study Intervention15.8 kilogramsStandard Deviation 1.6
Losartan and Placebo N-acetylcysteineHandgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort After All Doses of Study Intervention16.2 kilogramsStandard Deviation 11.1
Secondary

Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort at Baseline

Handgrip Strength of dominant hand is measured by handgrip dynamometry at 50% perceived effort with subjects performing one set of three contractions.

Time frame: baseline

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteineHandgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort at Baseline21.5 kilogramsStandard Deviation 6.5
N-acetylcysteine and Placebo LosartanHandgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort at Baseline23.2 kilogramsStandard Deviation 4.9
Losartan and Placebo N-acetylcysteineHandgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort at Baseline20.5 kilogramsStandard Deviation 16.7
Secondary

Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 100% Effort at Baseline

Handgrip Strength of non-dominant hand is measured by handgrip dynamometry at 100% effort with subjects performing one set of three contractions.

Time frame: baseline

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteineHandgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 100% Effort at Baseline47.1 kilogramsStandard Deviation 7.9
N-acetylcysteine and Placebo LosartanHandgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 100% Effort at Baseline31.1 kilogramsStandard Deviation 0.8
Losartan and Placebo N-acetylcysteineHandgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 100% Effort at Baseline26.5 kilogramsStandard Deviation 11.1
Secondary

Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 100% Perceived Effort After All Doses of Study Intervention

Handgrip Strength of non-dominant hand is measured by handgrip dynamometry at 100% perceived effort with subjects performing one set of three contractions.

Time frame: Post dose three of the intervention, average of 17 hours post dose one intervention

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteineHandgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 100% Perceived Effort After All Doses of Study Intervention42.3 kilogramsStandard Deviation 3.9
N-acetylcysteine and Placebo LosartanHandgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 100% Perceived Effort After All Doses of Study Intervention28.6 kilogramsStandard Deviation 2.7
Losartan and Placebo N-acetylcysteineHandgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 100% Perceived Effort After All Doses of Study Intervention30.2 kilogramsStandard Deviation 0.2
Secondary

Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort After All Doses of Study Intervention

Handgrip Strength of non-dominant hand is measured by handgrip dynamometry at 50% perceived effort with subjects performing one set of three contractions.

Time frame: Post dose three of the intervention, average of 17 hours post dose one intervention

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteineHandgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort After All Doses of Study Intervention17.8 kilogramsStandard Deviation 4.5
N-acetylcysteine and Placebo LosartanHandgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort After All Doses of Study Intervention14.8 kilogramsStandard Deviation 4.5
Losartan and Placebo N-acetylcysteineHandgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort After All Doses of Study Intervention13.7 kilogramsStandard Deviation 7.1
Secondary

Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort at Baseline

Handgrip Strength of non-dominant hand is measured by handgrip dynamometry at 50% perceived effort with subjects performing one set of three contractions.

Time frame: baseline

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteineHandgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort at Baseline24.2 kilogramsStandard Deviation 2.6
N-acetylcysteine and Placebo LosartanHandgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort at Baseline19.3 kilogramsStandard Deviation 1.9
Losartan and Placebo N-acetylcysteineHandgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort at Baseline17.0 kilogramsStandard Deviation 15.1
Secondary

Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale After Handgrip Fatigue Test After Study Intervention

The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention.

Time frame: Post dose three of the intervention, average of 17 hours post dose one intervention - Directly after handgrip fatigue test

Population: Data for 1 subject was not collected.

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteinePerceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale After Handgrip Fatigue Test After Study Intervention3.4 units on a scaleStandard Deviation 4.38
N-acetylcysteine and Placebo LosartanPerceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale After Handgrip Fatigue Test After Study Intervention11 units on a scale
Losartan and Placebo N-acetylcysteinePerceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale After Handgrip Fatigue Test After Study Intervention0.75 units on a scaleStandard Deviation 1.06
Secondary

Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale After Handgrip Fatigue Test at Baseline.

The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention.

Time frame: baseline - directly after handgrip fatigue test

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteinePerceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale After Handgrip Fatigue Test at Baseline.2.7 units on a scaleStandard Deviation 3.39
N-acetylcysteine and Placebo LosartanPerceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale After Handgrip Fatigue Test at Baseline.7.5 units on a scaleStandard Deviation 4.5
Losartan and Placebo N-acetylcysteinePerceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale After Handgrip Fatigue Test at Baseline.0.6 units on a scaleStandard Deviation 0.84
Secondary

Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale Before Handgrip Fatigue Test After Study Intervention

The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention.

Time frame: Post dose three of the intervention, average of 17 hours post dose one intervention - Before handgrip fatigue test

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteinePerceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale Before Handgrip Fatigue Test After Study Intervention1.45 units on a scaleStandard Deviation 1.62
N-acetylcysteine and Placebo LosartanPerceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale Before Handgrip Fatigue Test After Study Intervention1 units on a scaleStandard Deviation 1.41
Losartan and Placebo N-acetylcysteinePerceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale Before Handgrip Fatigue Test After Study Intervention0.65 units on a scaleStandard Deviation 0.92
Secondary

Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale Before Handgrip Fatigue Test at Baseline.

The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention.

Time frame: baseline - before handgrip fatigue test

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteinePerceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale Before Handgrip Fatigue Test at Baseline.0.3 units on a scaleStandard Deviation 0.14
N-acetylcysteine and Placebo LosartanPerceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale Before Handgrip Fatigue Test at Baseline.3.3 units on a scaleStandard Deviation 2.69
Losartan and Placebo N-acetylcysteinePerceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale Before Handgrip Fatigue Test at Baseline.0.2 units on a scaleStandard Deviation 0.28
Secondary

Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale After Handgrip Fatigue Test After Study Intervention

The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention.

Time frame: Post dose three of the intervention, average of 17 hours post dose one intervention - Directly after handgrip fatigue test

Population: Data for 1 subject was not recorded

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteinePerceptual Fatigue of Whole Body as Measured by Visual Analog Scale After Handgrip Fatigue Test After Study Intervention1.25 units on a scaleStandard Deviation 1.34
N-acetylcysteine and Placebo LosartanPerceptual Fatigue of Whole Body as Measured by Visual Analog Scale After Handgrip Fatigue Test After Study Intervention5.3 units on a scale
Losartan and Placebo N-acetylcysteinePerceptual Fatigue of Whole Body as Measured by Visual Analog Scale After Handgrip Fatigue Test After Study Intervention0.95 units on a scaleStandard Deviation 1.34
Secondary

Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale After Handgrip Fatigue Test at Baseline.

The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention.

Time frame: baseline - directly after handgrip fatigue test

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteinePerceptual Fatigue of Whole Body as Measured by Visual Analog Scale After Handgrip Fatigue Test at Baseline.1.05 units on a scaleStandard Deviation 1.2
N-acetylcysteine and Placebo LosartanPerceptual Fatigue of Whole Body as Measured by Visual Analog Scale After Handgrip Fatigue Test at Baseline.5 units on a scaleStandard Deviation 3.11
Losartan and Placebo N-acetylcysteinePerceptual Fatigue of Whole Body as Measured by Visual Analog Scale After Handgrip Fatigue Test at Baseline.0.6 units on a scaleStandard Deviation 0.85
Secondary

Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale Before Handgrip Fatigue Test After Study Intervention

The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention.

Time frame: Post dose three of the intervention, average of 17 hours post dose one intervention - Before handgrip fatigue test

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteinePerceptual Fatigue of Whole Body as Measured by Visual Analog Scale Before Handgrip Fatigue Test After Study Intervention0.7 units on a scaleStandard Deviation 0.42
N-acetylcysteine and Placebo LosartanPerceptual Fatigue of Whole Body as Measured by Visual Analog Scale Before Handgrip Fatigue Test After Study Intervention4.1 units on a scaleStandard Deviation 4.1
Losartan and Placebo N-acetylcysteinePerceptual Fatigue of Whole Body as Measured by Visual Analog Scale Before Handgrip Fatigue Test After Study Intervention0.55 units on a scaleStandard Deviation 0.77
Secondary

Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale Before Handgrip Fatigue Test at Baseline.

The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention.

Time frame: baseline - before handgrip fatigue test

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteinePerceptual Fatigue of Whole Body as Measured by Visual Analog Scale Before Handgrip Fatigue Test at Baseline.0.4 units on a scaleStandard Deviation 0.14
N-acetylcysteine and Placebo LosartanPerceptual Fatigue of Whole Body as Measured by Visual Analog Scale Before Handgrip Fatigue Test at Baseline.1.15 units on a scaleStandard Deviation 0.35
Losartan and Placebo N-acetylcysteinePerceptual Fatigue of Whole Body as Measured by Visual Analog Scale Before Handgrip Fatigue Test at Baseline.0.55 units on a scaleStandard Deviation 0.77
Secondary

Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Emotional Fatigue After All Doses of Study Intervention

Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the emotional fatigue scale is 24 to 0, with the higher number meaning more fatigue. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.

Time frame: Post dose three of the intervention, average of 17 hours post dose one intervention

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteinePersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Emotional Fatigue After All Doses of Study Intervention0.5 units on a scaleStandard Deviation 0.7
N-acetylcysteine and Placebo LosartanPersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Emotional Fatigue After All Doses of Study Intervention0 units on a scaleStandard Deviation 0
Losartan and Placebo N-acetylcysteinePersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Emotional Fatigue After All Doses of Study Intervention7.5 units on a scaleStandard Deviation 2.12
Secondary

Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Emotional Fatigue at Baseline

Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the emotional fatigue scale is 24 to 0, with the higher number meaning more fatigue. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteinePersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Emotional Fatigue at Baseline0.5 units on a scaleStandard Deviation 0.7
N-acetylcysteine and Placebo LosartanPersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Emotional Fatigue at Baseline0 units on a scaleStandard Deviation 0
Losartan and Placebo N-acetylcysteinePersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Emotional Fatigue at Baseline4 units on a scaleStandard Deviation 5.6
Secondary

Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale General Fatigue After All Doses of Study Intervention

Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the general fatigue scale is 24 to 0, with the higher number meaning more fatigue. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.

Time frame: Post dose three of the intervention, average of 17 hours post dose one intervention

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteinePersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale General Fatigue After All Doses of Study Intervention0 units on a scaleStandard Deviation 0
N-acetylcysteine and Placebo LosartanPersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale General Fatigue After All Doses of Study Intervention2 units on a scaleStandard Deviation 2.8
Losartan and Placebo N-acetylcysteinePersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale General Fatigue After All Doses of Study Intervention6.5 units on a scaleStandard Deviation 0.7
Secondary

Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale General Fatigue at Baseline

Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the general fatigue scale is 24 to 0, with the higher number meaning more fatigue. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteinePersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale General Fatigue at Baseline0 units on a scaleStandard Deviation 0
N-acetylcysteine and Placebo LosartanPersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale General Fatigue at Baseline1.5 units on a scaleStandard Deviation 2.12
Losartan and Placebo N-acetylcysteinePersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale General Fatigue at Baseline3.5 units on a scaleStandard Deviation 2.11
Secondary

Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Mental Fatigue After All Doses of Study Intervention

Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the mental fatigue scale is 24 to 0, with the higher number meaning more fatigue The range of the total score is -24 to 96, with the higher the number meaning more fatigue.

Time frame: Post dose three of the intervention, average of 17 hours post dose one intervention

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteinePersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Mental Fatigue After All Doses of Study Intervention0 units on a scaleStandard Deviation 0
N-acetylcysteine and Placebo LosartanPersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Mental Fatigue After All Doses of Study Intervention1 units on a scaleStandard Deviation 1.4
Losartan and Placebo N-acetylcysteinePersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Mental Fatigue After All Doses of Study Intervention6.5 units on a scaleStandard Deviation 0.7
Secondary

Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Mental Fatigue at Baseline

Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the mental fatigue scale is 24 to 0, with the higher number meaning more fatigue. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteinePersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Mental Fatigue at Baseline0.5 units on a scaleStandard Deviation 0.7
N-acetylcysteine and Placebo LosartanPersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Mental Fatigue at Baseline0.5 units on a scaleStandard Deviation 0.7
Losartan and Placebo N-acetylcysteinePersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Mental Fatigue at Baseline4.5 units on a scaleStandard Deviation 0.7
Secondary

Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Physical Fatigue After All Doses of Study Intervention

Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the physical fatigue scale is 24 to 0, with the higher number meaning more fatigue. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.

Time frame: Post dose three of the intervention, average of 17 hours post dose one intervention

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteinePersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Physical Fatigue After All Doses of Study Intervention0 units on a scaleStandard Deviation 0
N-acetylcysteine and Placebo LosartanPersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Physical Fatigue After All Doses of Study Intervention0.5 units on a scaleStandard Deviation 0.7
Losartan and Placebo N-acetylcysteinePersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Physical Fatigue After All Doses of Study Intervention7 units on a scaleStandard Deviation 1.4
Secondary

Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Physical Fatigue at Baseline

Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the physical fatigue scale is 24 to 0, with the higher number meaning more fatigue. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteinePersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Physical Fatigue at Baseline0.5 units on a scaleStandard Deviation 0.7
N-acetylcysteine and Placebo LosartanPersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Physical Fatigue at Baseline0.5 units on a scaleStandard Deviation 0.7
Losartan and Placebo N-acetylcysteinePersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Physical Fatigue at Baseline3 units on a scaleStandard Deviation 1.4
Secondary

Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Vigor Fatigue After All Doses of Study Intervention

Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the vigor scale is 0 to 24, with the higher number meaning more vigor. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.

Time frame: Post dose three of the intervention, average of 17 hours post dose one intervention

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteinePersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Vigor Fatigue After All Doses of Study Intervention20.5 units on a scaleStandard Deviation 3.5
N-acetylcysteine and Placebo LosartanPersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Vigor Fatigue After All Doses of Study Intervention15.5 units on a scaleStandard Deviation 3.5
Losartan and Placebo N-acetylcysteinePersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Vigor Fatigue After All Doses of Study Intervention14 units on a scaleStandard Deviation 1.4
Secondary

Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Vigor Fatigue at Baseline

Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the vigor scale is 0 to 24, with the higher number meaning more vigor. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteinePersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Vigor Fatigue at Baseline18 units on a scaleStandard Deviation 0
N-acetylcysteine and Placebo LosartanPersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Vigor Fatigue at Baseline15 units on a scaleStandard Deviation 2.8
Losartan and Placebo N-acetylcysteinePersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Vigor Fatigue at Baseline16.5 units on a scaleStandard Deviation 3.5
Secondary

Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Total Score After All Doses of Study Intervention

Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.

Time frame: Post dose three of the intervention, average of 17 hours post dose one intervention

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteinePersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Total Score After All Doses of Study Intervention-20 units on a scaleStandard Deviation 2.8
N-acetylcysteine and Placebo LosartanPersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Total Score After All Doses of Study Intervention-12 units on a scaleStandard Deviation 1.4
Losartan and Placebo N-acetylcysteinePersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Total Score After All Doses of Study Intervention13.5 units on a scaleStandard Deviation 2.12
Secondary

Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Total Score at Baseline

Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Placebo Losartan and Placebo N-acetylcysteinePersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Total Score at Baseline-16.5 units on a scaleStandard Deviation 2.12
N-acetylcysteine and Placebo LosartanPersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Total Score at Baseline-12.5 units on a scaleStandard Deviation 6.36
Losartan and Placebo N-acetylcysteinePersonal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Total Score at Baseline-1.5 units on a scaleStandard Deviation 4.95

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026