Gulf War Illness, Chronic Fatigue, Ubiquinol, Coenzyme Q10
Conditions
Keywords
Chronic Pain, Cognitive Disorders, Inflammation, Neurologic manifestations, Dementia, Mental Disorders, Ubiquinol/ubiquinone, Pathologic Processes, Nervous System Diseases, Hormones, Hormone Substitutes, and Hormone Antagon, Anti-Inflammatory Agents, Pharmacologic Actions, Therapeutic Uses, Physiological Effects of Drugs, Gulf war illness, Chronic fatigue
Brief summary
The primary objective of this clinical trial is to determine if treatment with ubiquinol, a form of coenzyme Q10, improves the physical function of men and women Veterans suffering from Gulf War Illness (GWI). The primary outcome measure is a change from baseline on the Short Form Health Survey 36-item (SF-36), with respect to physical functioning and symptoms. Secondary outcome measures include changes from baseline levels on GWI-associated biomarkers in peripheral blood and GWI-associated symptoms of chronic pain, fatigue, insomnia, activity level, and cognitive and mental functioning.
Detailed description
As many as a third of the nearly 700,000 military personnel deployed during Desert Shield and Desert Storm (Aug 2, 1990 to July 31, 1991) in the Kuwaiti Theater of Operations are suffering from Gulf War Illness (GWI), an unexplained chronic illness characterized by multiple symptoms. Gulf War Veterans experienced environmental exposures that are known to be oxidative stressors which contribute to cell injury, resulting in mitochondrial dysfunction Exploratory studies using interventions that support cell functioning and prevent or repair stress mediators suggest a role for these targeted interventions, such as Coenzyme Q10. The goal of this clinical trial is to determine if Coenzyme Q10 is effective in increasing physical functioning for Veterans with Gulf War Illness. This is a randomized, two group, double blind, placebo controlled, Phase III clinical trial. The treatment group will receive a (2x200 mg for 2 months and 1x200 mg for 4 months) once a day of ubiquinol for 6 months. The placebo group will receive matching placebo (2x200 mg for 2 months and 1x200 mg for 4 months) once a day of ubiquinol for 6 months. The primary outcome measure for this clinical trial is a change from baseline of SF-36, with respect to physical functioning and symptoms. The secondary outcome measures include changes from baseline of peripheral blood levels of biomarkers, and of GWI-associated symptoms of chronic pain, fatigue, sleep issues, and cognitive impairment.
Interventions
DRUGUbiquinol
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
DRUGPlacebo
Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male and female Veterans who were deployed in 1990 -1991 Gulf War. * Veterans who currently meet the Kansas Gulf War Study Case Definition for Gulf War Illness. * Veterans who were in good health based on medical history prior to 1990. * Veterans whose severity of illness is moderate to severe, evidenced by scoring less than 30 of 100 on the physical domain of SF36.
Exclusion criteria
* Veteran has a condition that may interfere with the ability to accurately report symptoms, such as: * severe psychiatric problems * schizophrenia * bipolar disorder * major depression with psychotic or melancholic features * delusional disorders alcohol or drug dependence requiring hospitalization, or regular illegal drug use or other psychiatric condition requiring inpatient stay in the 6 months prior to study entry. * Has dementias of any type * Currently does not have exclusionary conditions that could reasonably be responsible for the symptoms in multi-symptom disorders, as determined by Investigator (based on Reeves et al.2003). * Is pregnant or breastfeeding or plans to become pregnant within the next 6 months. * Medical conditions excluded: * organ failure * defined rheumatologic inflammatory disorders * chronic active infections such as HIV, hepatitis B and C, or transplant * primary sleep disorders * Medications that could potentially impact immune function excluded: * steroids * immune-suppressives * nutraceuticals that are formulated to impact mitochondrial function or oxidative stress * Biologic response modifiers within 3 months of study entry. * Current use of Coumadin (given the vitamin K structural similarity of CoQ10) * Known allergy to CoQ10 and/or inactive ingredients of active and placebo soft gelatin capsules * Willingness to have 12 weeks of washout of current CoQ10, ubiquinol, or ubiquinone supplements will be required between the screening and baseline visits. * Common multivitamin preparations will be allowed if taken without change throughout the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Veterans Short Form 36-Item Health Survey Physical Component Summary | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | Veterans Health Survey contains 36 items to measure health functioning from the patient's point of view. The scale is 0-100. The higher value indicates better physical health. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gulf War Illness Health Symptom Checklist | Baseline, Weeks 4, 8, 12, 16, 20, 24, and 28 | The Gulf War Illness Health Symptoms Checklist asks questions about symptoms related to Gulf War Illness. The linear scale is 0-42. The higher value indicates more symptoms. |
| Brief Pain Inventory | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | The Brief Pain Inventory is a linear scale of pain. The scale is 0-10. The higher value indicates more pain. |
| Pittsburgh Sleep Quality Index | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | The PSQI measures quality and patterns of sleep and wake cycles and is completed by the participant. The Pittsburgh Sleep Quality Index scale is 0-21. The higher value indicates more sleep disturbance. |
| Hamilton Anxiety Scale (HAM-A) | Baseline, Weeks 8, 16, and 24 | This measure allows the participant to rate levels of anxiety. The Hamilton Anxiety Scale is 0-56. The higher value indicates more anxiety. |
| Hamilton Depression Scale (HAM-D) | Baseline, Weeks 8, 16, and 24 | This measure allows the participant to rate level of depression. The Hamilton Depression Scale is a linear scale 0-62. The higher value indicates more depression. |
| Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS) | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | Veterans Health Survey contains 36 items to measure health functioning from the patient's point of view. The Veterans Short Form 36-item Health Survey Mental Component Score scale is 0-100. The higher value indicates more favorable mental health. |
| Connors Continuous Performance Test (CPT-3): Hit Reaction Time | Baseline, Weeks 8, 16, and 24 | CPT-3 asks questions about cognitive symptoms related to attention and reaction time. The Connors Continuous Performance Test Hit Reaction Time scale is 0-No limit. The higher score indicates poorer outcomes. |
| Connors Continuous Performance Test (CPT-3):Omissions T-score | Baseline, Weeks 8, 16, and 24 | CPT-3 asks questions about cognitive symptoms related to attention and reaction time. The Connors Continuous Performance Test Omissions score is 0-100. 50 indicates the population mean with a standard deviation of 10. The higher T-score indicates poorer outcomes. |
| Connors Continuous Performance Test (CPT-3):Commissions T-score | Baseline, Weeks 8, 16, and 24 | CPT-3 asks questions about cognitive symptoms related to attention and reaction time. The Connors Continuous Performance Test Commissions T-score scale is 0-100. 50 indicates the population mean with a standard deviation of 10. The higher score indicates poorer outcomes. |
| Brief Visual Memory Test (BVMT): Delayed Recall | Baseline, Weeks 8, 16, and 24 | BVMT asks questions about cognitive symptoms related to visual memory. The Brief Visual Memory Test Delayed Recall scale is 0-12. The higher value indicates better performance. |
| Brief Visual Memory Test (BVMT): Percent Retained | Baseline, Weeks 8, 16, and 24 | BVMT asks questions about cognitive symptoms related to visual memory. The Brief Visual Memory Test Percent Retained score is 0-100. The higher value indicates better performance. |
| California Verbal Learning Test (CVLT-II): Correct Trials # 1-5 | Baseline, Weeks 8, 16, and 24 | CVLT-II asks questions about cognitive symptoms related to recall and memory. The California Verbal Learning Test (CVLT-II) Correct Trials #1-5 score is 0-80. The higher score indicates better performance. |
| California Verbal Learning Test (CVLT-II): Short Delay | Baseline, Weeks 8, 16, and 24 | CVLT-II asks questions about cognitive symptoms related to recall and memory. The California Verbal Learning Test (CVLT-II) Short Delay Test scale is 0-16. The higher score indicates better performance. |
| California Verbal Learning Test (CVLT-II): Long Delay Test | Baseline, Weeks 8, 16, and 24 | CVLT-II asks questions about cognitive symptoms related to recall and memory. The California Verbal Learning Test (CVLT-II) Long Delay Test scale is 0-16. The higher score indicates better performance. |
| Multidimensional Fatigue Inventory (MFI) | Baseline, Weeks 4, 8, 12, 16, 20, and 24 | MFI asks questions about general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. The Multidimensional Fatigue Inventory score is 0-100. The higher value indicates more fatigue. |
| FitBit Sleep Measurement - Total Sleep | Baseline to 8 weeks, 8 weeks to 16 weeks, 16 weeks to 24 weeks | FitBit measures the duration of sleep daily via a bracelet-type instrument worn on the participant's wrist throughout the study. No normative data for FitBit Sleep was available. |
| FitBit Sleep Measurement - Types of Sleep | Baseline to 8 weeks, 8 weeks to 16 weeks, 16 weeks to 24 weeks | FitBit measures the time spent in each type of sleep (Light, Deep, Rapid Eye Movement (REM)) daily via a bracelet-type instrument worn on the participant's wrist throughout the study. No normative data for FitBit Sleep was available. |
| Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets | Baseline, Weeks 8, 16, and 24 | Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: white blood cell (WBC) counts and platelets. Average values fell within the normal range for this type of assay. |
| Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Red Blood Cell (RBC) Counts | Baseline, Weeks 8, 16, and 24 | Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: red blood cell counts. Average values fell within the normal range for this type of assay. |
| Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Baseline, Weeks 8, 16, and 24 | Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: percentages of white blood cells. Average values fell within the normal range for this type of assay. |
| Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hemoglobin | Baseline, Weeks 8, 16, and 24 | Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: hemoglobin. Average values fell within the normal range for this type of assay. |
| Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hematocrit | Baseline, Weeks 8, 16, and 24 | Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: percentages of hematocrit in blood. Average values fell within the normal range for this type of assay. |
| Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: TSH | Baseline, Weeks 8, 16, and 24 | Thyroid status is assessed using a chemiluminescent method: thyroid stimulating hormone (TSH). Average values fell within the normal range for this type of assay. |
| Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT3 | Baseline, Weeks 8, 16, and 24 | Thyroid status is assessed using a chemiluminescent method: Free triiodothyronine (FT3). Average values fell within the normal range for this type of assay. |
| Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT4 | Baseline, Weeks 8, 16, and 24 | Thyroid status is assessed using a chemiluminescent method: Free thyroxine (FT4). Average values fell within the normal range for this type of assay. |
| Response to Therapy on Cortisol Levels | Baseline, Weeks 8, 16, and 24 upon waking, mid-morning, evening, and sleep for each. | Cortisol will be measured using a 24-hour salivary collection to assess circadian rhythm. |
| Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Testosterone | Baseline, Weeks 8, 16, and 24 | HPG will measure testosterone. Average values fell within the normal range for this type of assay. |
| Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Progesterone | Baseline, Weeks 8, 16, and 24 | HPG will measure progesterone. Average values fell within the normal range for this type of assay. |
| Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Estradiol | Baseline, Weeks 8, 16, and 24 | HPG will measure estradiol. Average values fell within the normal range for this type of assay. |
| Davidson Trauma Scale | Baseline, Weeks 8, 16, and 24 | Davidson Trauma Scale asks questions about stress, arousal, and avoidance. The scale is 0 - 136. The higher value indicates worse outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ubiquinol Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking | 51 |
| Placebo Take oral tablets as directed (2x200 mg for 2 months; 1x 200 mg for 4 months) with food each morning-upon waking
Placebo: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking | 49 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 7 | 4 |
| Overall Study | Ubiquinol group -not deployed to Gulf; Placebo group- ill with COVID | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Ubiquinol | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 6 | 54 years STANDARD_DEVIATION 5 | 53 years STANDARD_DEVIATION 5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 22 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 77 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 24 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 11 Participants | 14 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 27 Participants | 59 Participants | 32 Participants |
| Sex: Female, Male Female | 5 Participants | 8 Participants | 3 Participants |
| Sex: Female, Male Male | 46 Participants | 92 Participants | 46 Participants |
| SF 36 Physical Component Summary (PCS) | 55 units on a scale STANDARD_DEVIATION 23 | 56 units on a scale STANDARD_DEVIATION 22 | 56 units on a scale STANDARD_DEVIATION 22 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 49 |
| other Total, other adverse events | 0 / 51 | 0 / 49 |
| serious Total, serious adverse events | 0 / 51 | 0 / 49 |
Outcome results
Primary
Veterans Short Form 36-Item Health Survey Physical Component Summary
Veterans Health Survey contains 36 items to measure health functioning from the patient's point of view. The scale is 0-100. The higher value indicates better physical health.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Population: Intention-to-Treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | Veterans Short Form 36-Item Health Survey Physical Component Summary | Change Baseline to 4 Weeks | 1.6 units on a scale | Standard Deviation 11.1 |
| Ubiquinol | Veterans Short Form 36-Item Health Survey Physical Component Summary | Change Baseline to 8 Weeks | 1.4 units on a scale | Standard Deviation 12.7 |
| Ubiquinol | Veterans Short Form 36-Item Health Survey Physical Component Summary | Change Baseline to 12 Weeks | 1.5 units on a scale | Standard Deviation 15.9 |
| Ubiquinol | Veterans Short Form 36-Item Health Survey Physical Component Summary | Change Baseline to 16 Weeks | 2.1 units on a scale | Standard Deviation 14.5 |
| Ubiquinol | Veterans Short Form 36-Item Health Survey Physical Component Summary | Change Baseline to 20 Weeks | 1.6 units on a scale | Standard Deviation 14.7 |
| Ubiquinol | Veterans Short Form 36-Item Health Survey Physical Component Summary | Change Baseline to 24 Weeks | 0.7 units on a scale | Standard Deviation 12.5 |
| Placebo | Veterans Short Form 36-Item Health Survey Physical Component Summary | Change Baseline to 20 Weeks | 0.7 units on a scale | Standard Deviation 14.3 |
| Placebo | Veterans Short Form 36-Item Health Survey Physical Component Summary | Change Baseline to 4 Weeks | -1.1 units on a scale | Standard Deviation 10.1 |
| Placebo | Veterans Short Form 36-Item Health Survey Physical Component Summary | Change Baseline to 16 Weeks | 1.8 units on a scale | Standard Deviation 12.4 |
| Placebo | Veterans Short Form 36-Item Health Survey Physical Component Summary | Change Baseline to 8 Weeks | 1.1 units on a scale | Standard Deviation 10.3 |
| Placebo | Veterans Short Form 36-Item Health Survey Physical Component Summary | Change Baseline to 24 Weeks | 0.3 units on a scale | Standard Deviation 12.7 |
| Placebo | Veterans Short Form 36-Item Health Survey Physical Component Summary | Change Baseline to 12 Weeks | -1.8 units on a scale | Standard Deviation 13.1 |
Secondary
Brief Pain Inventory
The Brief Pain Inventory is a linear scale of pain. The scale is 0-10. The higher value indicates more pain.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | Brief Pain Inventory | Change from baseline to 8 weeks | -0.1 units on a scale | Standard Deviation 1.6 |
| Ubiquinol | Brief Pain Inventory | Change from baseline to 16 weeks | -0.1 units on a scale | Standard Deviation 1.8 |
| Ubiquinol | Brief Pain Inventory | Change from baseline to 4 weeks | 0 units on a scale | Standard Deviation 1.1 |
| Ubiquinol | Brief Pain Inventory | Change from baseline to 20 weeks | 0.2 units on a scale | Standard Deviation 1.6 |
| Ubiquinol | Brief Pain Inventory | Change from baseline to 12 weeks | 0.3 units on a scale | Standard Deviation 1.7 |
| Ubiquinol | Brief Pain Inventory | Change from baseline to 24 weeks | -0.3 units on a scale | Standard Deviation 1.4 |
| Placebo | Brief Pain Inventory | Change from baseline to 24 weeks | -0.3 units on a scale | Standard Deviation 1.5 |
| Placebo | Brief Pain Inventory | Change from baseline to 4 weeks | 0 units on a scale | Standard Deviation 1.3 |
| Placebo | Brief Pain Inventory | Change from baseline to 8 weeks | 0.3 units on a scale | Standard Deviation 1.6 |
| Placebo | Brief Pain Inventory | Change from baseline to 12 weeks | 0.3 units on a scale | Standard Deviation 1.6 |
| Placebo | Brief Pain Inventory | Change from baseline to 16 weeks | 0.1 units on a scale | Standard Deviation 1.4 |
| Placebo | Brief Pain Inventory | Change from baseline to 20 weeks | 0.6 units on a scale | Standard Deviation 1.8 |
Secondary
Brief Visual Memory Test (BVMT): Delayed Recall
BVMT asks questions about cognitive symptoms related to visual memory. The Brief Visual Memory Test Delayed Recall scale is 0-12. The higher value indicates better performance.
Time frame: Baseline, Weeks 8, 16, and 24
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | Brief Visual Memory Test (BVMT): Delayed Recall | Change from baseline to8 weeks | 0.3 score on a scale | Standard Deviation 2.3 |
| Ubiquinol | Brief Visual Memory Test (BVMT): Delayed Recall | Change from baseline to 16 weeks | 0.3 score on a scale | Standard Deviation 2.8 |
| Ubiquinol | Brief Visual Memory Test (BVMT): Delayed Recall | Change from baseline to 24 weeks | 0.4 score on a scale | Standard Deviation 2.7 |
| Placebo | Brief Visual Memory Test (BVMT): Delayed Recall | Change from baseline to8 weeks | 0.3 score on a scale | Standard Deviation 2.4 |
| Placebo | Brief Visual Memory Test (BVMT): Delayed Recall | Change from baseline to 16 weeks | 0.9 score on a scale | Standard Deviation 2 |
| Placebo | Brief Visual Memory Test (BVMT): Delayed Recall | Change from baseline to 24 weeks | 0.4 score on a scale | Standard Deviation 2.2 |
Secondary
Brief Visual Memory Test (BVMT): Percent Retained
BVMT asks questions about cognitive symptoms related to visual memory. The Brief Visual Memory Test Percent Retained score is 0-100. The higher value indicates better performance.
Time frame: Baseline, Weeks 8, 16, and 24
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | Brief Visual Memory Test (BVMT): Percent Retained | Change from baseline to 8 weeks | -4.1 score on a scale | Standard Deviation 42.9 |
| Ubiquinol | Brief Visual Memory Test (BVMT): Percent Retained | Change from baseline to 16 weeks | -5.6 score on a scale | Standard Deviation 24.6 |
| Ubiquinol | Brief Visual Memory Test (BVMT): Percent Retained | Change from baseline to 24 weeks | -0.4 score on a scale | Standard Deviation 52.3 |
| Placebo | Brief Visual Memory Test (BVMT): Percent Retained | Change from baseline to 8 weeks | 13.7 score on a scale | Standard Deviation 43 |
| Placebo | Brief Visual Memory Test (BVMT): Percent Retained | Change from baseline to 16 weeks | 1.1 score on a scale | Standard Deviation 24.7 |
| Placebo | Brief Visual Memory Test (BVMT): Percent Retained | Change from baseline to 24 weeks | 0.4 score on a scale | Standard Deviation 39.4 |
Secondary
California Verbal Learning Test (CVLT-II): Correct Trials # 1-5
CVLT-II asks questions about cognitive symptoms related to recall and memory. The California Verbal Learning Test (CVLT-II) Correct Trials #1-5 score is 0-80. The higher score indicates better performance.
Time frame: Baseline, Weeks 8, 16, and 24
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | California Verbal Learning Test (CVLT-II): Correct Trials # 1-5 | Change from baseline to 8 weeks | 0.4 score on a scale | Standard Deviation 7 |
| Ubiquinol | California Verbal Learning Test (CVLT-II): Correct Trials # 1-5 | Change from baseline to 16 weeks | 4.0 score on a scale | Standard Deviation 8.4 |
| Ubiquinol | California Verbal Learning Test (CVLT-II): Correct Trials # 1-5 | Change from baseline to 24 weeks | 5.8 score on a scale | Standard Deviation 8.8 |
| Placebo | California Verbal Learning Test (CVLT-II): Correct Trials # 1-5 | Change from baseline to 8 weeks | 0.9 score on a scale | Standard Deviation 9.8 |
| Placebo | California Verbal Learning Test (CVLT-II): Correct Trials # 1-5 | Change from baseline to 16 weeks | 6.7 score on a scale | Standard Deviation 7.5 |
| Placebo | California Verbal Learning Test (CVLT-II): Correct Trials # 1-5 | Change from baseline to 24 weeks | 6.9 score on a scale | Standard Deviation 10 |
Secondary
California Verbal Learning Test (CVLT-II): Long Delay Test
CVLT-II asks questions about cognitive symptoms related to recall and memory. The California Verbal Learning Test (CVLT-II) Long Delay Test scale is 0-16. The higher score indicates better performance.
Time frame: Baseline, Weeks 8, 16, and 24
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | California Verbal Learning Test (CVLT-II): Long Delay Test | Change from baseline to 8 weeks | -0.4 score on a scale | Standard Deviation 3.7 |
| Ubiquinol | California Verbal Learning Test (CVLT-II): Long Delay Test | Change from baseline to 16 weeks | 0.3 score on a scale | Standard Deviation 3.6 |
| Ubiquinol | California Verbal Learning Test (CVLT-II): Long Delay Test | Change from baseline to 24 weeks | 0.9 score on a scale | Standard Deviation 2.9 |
| Placebo | California Verbal Learning Test (CVLT-II): Long Delay Test | Change from baseline to 8 weeks | 0.6 score on a scale | Standard Deviation 2.7 |
| Placebo | California Verbal Learning Test (CVLT-II): Long Delay Test | Change from baseline to 16 weeks | 1.6 score on a scale | Standard Deviation 2.8 |
| Placebo | California Verbal Learning Test (CVLT-II): Long Delay Test | Change from baseline to 24 weeks | 1.4 score on a scale | Standard Deviation 2.7 |
Secondary
California Verbal Learning Test (CVLT-II): Short Delay
CVLT-II asks questions about cognitive symptoms related to recall and memory. The California Verbal Learning Test (CVLT-II) Short Delay Test scale is 0-16. The higher score indicates better performance.
Time frame: Baseline, Weeks 8, 16, and 24
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | California Verbal Learning Test (CVLT-II): Short Delay | Change from baseline to 8 weeks | 0.2 units on a scale | Standard Deviation 3 |
| Ubiquinol | California Verbal Learning Test (CVLT-II): Short Delay | Change from baseline to 16 weeks | 1.1 units on a scale | Standard Deviation 2.5 |
| Ubiquinol | California Verbal Learning Test (CVLT-II): Short Delay | Change from baseline to 24 weeks | 1.1 units on a scale | Standard Deviation 2.6 |
| Placebo | California Verbal Learning Test (CVLT-II): Short Delay | Change from baseline to 8 weeks | 0.5 units on a scale | Standard Deviation 2.4 |
| Placebo | California Verbal Learning Test (CVLT-II): Short Delay | Change from baseline to 16 weeks | 1.5 units on a scale | Standard Deviation 1.9 |
| Placebo | California Verbal Learning Test (CVLT-II): Short Delay | Change from baseline to 24 weeks | 1.5 units on a scale | Standard Deviation 2.8 |
Secondary
Connors Continuous Performance Test (CPT-3):Commissions T-score
CPT-3 asks questions about cognitive symptoms related to attention and reaction time. The Connors Continuous Performance Test Commissions T-score scale is 0-100. 50 indicates the population mean with a standard deviation of 10. The higher score indicates poorer outcomes.
Time frame: Baseline, Weeks 8, 16, and 24
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | Connors Continuous Performance Test (CPT-3):Commissions T-score | Change from baseline to 8 weeks | -3.2 T-score | Standard Deviation 8 |
| Ubiquinol | Connors Continuous Performance Test (CPT-3):Commissions T-score | Change from baseline to 16 weeks | -3.2 T-score | Standard Deviation 8.6 |
| Ubiquinol | Connors Continuous Performance Test (CPT-3):Commissions T-score | Change from baseline to 24 weeks | -3.5 T-score | Standard Deviation 8.8 |
| Placebo | Connors Continuous Performance Test (CPT-3):Commissions T-score | Change from baseline to 8 weeks | -2.0 T-score | Standard Deviation 5.3 |
| Placebo | Connors Continuous Performance Test (CPT-3):Commissions T-score | Change from baseline to 16 weeks | -3.0 T-score | Standard Deviation 6.7 |
| Placebo | Connors Continuous Performance Test (CPT-3):Commissions T-score | Change from baseline to 24 weeks | -4.5 T-score | Standard Deviation 7.2 |
Secondary
Connors Continuous Performance Test (CPT-3): Hit Reaction Time
CPT-3 asks questions about cognitive symptoms related to attention and reaction time. The Connors Continuous Performance Test Hit Reaction Time scale is 0-No limit. The higher score indicates poorer outcomes.
Time frame: Baseline, Weeks 8, 16, and 24
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | Connors Continuous Performance Test (CPT-3): Hit Reaction Time | Change from baseline to 8 weeks | 10.7 score on a scale | Standard Deviation 43.1 |
| Ubiquinol | Connors Continuous Performance Test (CPT-3): Hit Reaction Time | Change from baseline to 16 weeks | 17.2 score on a scale | Standard Deviation 46.9 |
| Ubiquinol | Connors Continuous Performance Test (CPT-3): Hit Reaction Time | Change from baseline to 24 weeks | 24.0 score on a scale | Standard Deviation 46.9 |
| Placebo | Connors Continuous Performance Test (CPT-3): Hit Reaction Time | Change from baseline to 8 weeks | -1.6 score on a scale | Standard Deviation 34.3 |
| Placebo | Connors Continuous Performance Test (CPT-3): Hit Reaction Time | Change from baseline to 16 weeks | -3.0 score on a scale | Standard Deviation 49 |
| Placebo | Connors Continuous Performance Test (CPT-3): Hit Reaction Time | Change from baseline to 24 weeks | 12.8 score on a scale | Standard Deviation 45.4 |
Secondary
Connors Continuous Performance Test (CPT-3):Omissions T-score
CPT-3 asks questions about cognitive symptoms related to attention and reaction time. The Connors Continuous Performance Test Omissions score is 0-100. 50 indicates the population mean with a standard deviation of 10. The higher T-score indicates poorer outcomes.
Time frame: Baseline, Weeks 8, 16, and 24
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | Connors Continuous Performance Test (CPT-3):Omissions T-score | Change from baseline to 8 weeks | -2.0 T-score | Standard Deviation 7.6 |
| Ubiquinol | Connors Continuous Performance Test (CPT-3):Omissions T-score | Change from baseline to 16 weeks | 0.2 T-score | Standard Deviation 9.1 |
| Ubiquinol | Connors Continuous Performance Test (CPT-3):Omissions T-score | Change from baseline to 24 weeks | -0.4 T-score | Standard Deviation 9.1 |
| Placebo | Connors Continuous Performance Test (CPT-3):Omissions T-score | Change from baseline to 8 weeks | -1.2 T-score | Standard Deviation 5.2 |
| Placebo | Connors Continuous Performance Test (CPT-3):Omissions T-score | Change from baseline to 16 weeks | -1.6 T-score | Standard Deviation 8.5 |
| Placebo | Connors Continuous Performance Test (CPT-3):Omissions T-score | Change from baseline to 24 weeks | -1.6 T-score | Standard Deviation 7.8 |
Secondary
Davidson Trauma Scale
Davidson Trauma Scale asks questions about stress, arousal, and avoidance. The scale is 0 - 136. The higher value indicates worse outcome.
Time frame: Baseline, Weeks 8, 16, and 24
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | Davidson Trauma Scale | Change from baseline to 8 weeks | -7.6 score on a scale | Standard Deviation 24.6 |
| Ubiquinol | Davidson Trauma Scale | Change from baseline to 16 weeks | -5.4 score on a scale | Standard Deviation 24 |
| Ubiquinol | Davidson Trauma Scale | Change from baseline to 24 weeks | -13.3 score on a scale | Standard Deviation 18.9 |
| Placebo | Davidson Trauma Scale | Change from baseline to 8 weeks | -6.7 score on a scale | Standard Deviation 23.4 |
| Placebo | Davidson Trauma Scale | Change from baseline to 16 weeks | -12.1 score on a scale | Standard Deviation 26.5 |
| Placebo | Davidson Trauma Scale | Change from baseline to 24 weeks | -9.4 score on a scale | Standard Deviation 21.8 |
Secondary
FitBit Sleep Measurement - Total Sleep
FitBit measures the duration of sleep daily via a bracelet-type instrument worn on the participant's wrist throughout the study. No normative data for FitBit Sleep was available.
Time frame: Baseline to 8 weeks, 8 weeks to 16 weeks, 16 weeks to 24 weeks
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | FitBit Sleep Measurement - Total Sleep | Average Total Sleep, Baseline to Week 8 | 344.14 minutes | Standard Deviation 54.6 |
| Ubiquinol | FitBit Sleep Measurement - Total Sleep | Average Total Sleep, Week 8 to Week 16 | 346.31 minutes | Standard Deviation 60.85 |
| Ubiquinol | FitBit Sleep Measurement - Total Sleep | Average Total Sleep, Week 16 to Week 24 | 350.98 minutes | Standard Deviation 58.28 |
| Placebo | FitBit Sleep Measurement - Total Sleep | Average Total Sleep, Baseline to Week 8 | 343.4 minutes | Standard Deviation 59.8 |
| Placebo | FitBit Sleep Measurement - Total Sleep | Average Total Sleep, Week 8 to Week 16 | 348.15 minutes | Standard Deviation 57.57 |
| Placebo | FitBit Sleep Measurement - Total Sleep | Average Total Sleep, Week 16 to Week 24 | 334.22 minutes | Standard Deviation 70.86 |
Secondary
FitBit Sleep Measurement - Types of Sleep
FitBit measures the time spent in each type of sleep (Light, Deep, Rapid Eye Movement (REM)) daily via a bracelet-type instrument worn on the participant's wrist throughout the study. No normative data for FitBit Sleep was available.
Time frame: Baseline to 8 weeks, 8 weeks to 16 weeks, 16 weeks to 24 weeks
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | FitBit Sleep Measurement - Types of Sleep | Awake, Week 8 to Week 16 | 10.64 average percentage of total time in bed | Standard Deviation 4.28 |
| Ubiquinol | FitBit Sleep Measurement - Types of Sleep | Light Sleep, Week 16 to Week 24 | 64.49 average percentage of total time in bed | Standard Deviation 6.04 |
| Ubiquinol | FitBit Sleep Measurement - Types of Sleep | Asleep, Week 8 to Week 16 | 89.1 average percentage of total time in bed | Standard Deviation 2.6 |
| Ubiquinol | FitBit Sleep Measurement - Types of Sleep | Deep Sleep, Baseline to Week 8 | 15.29 average percentage of total time in bed | Standard Deviation 3.62 |
| Ubiquinol | FitBit Sleep Measurement - Types of Sleep | Awake, Week 16 to Week 24 | 10.92 average percentage of total time in bed | Standard Deviation 3.28 |
| Ubiquinol | FitBit Sleep Measurement - Types of Sleep | Deep Sleep, Week 8 to Week 16 | 14.04 average percentage of total time in bed | Standard Deviation 3.97 |
| Ubiquinol | FitBit Sleep Measurement - Types of Sleep | Awake, Baseline to Week 8 | 10.68 average percentage of total time in bed | Standard Deviation 2.71 |
| Ubiquinol | FitBit Sleep Measurement - Types of Sleep | Deep Sleep, Week 16 to Week 24 | 15.78 average percentage of total time in bed | Standard Deviation 3.57 |
| Ubiquinol | FitBit Sleep Measurement - Types of Sleep | Light Sleep, Baseline to Week 8 | 65.37 average percentage of total time in bed | Standard Deviation 6.23 |
| Ubiquinol | FitBit Sleep Measurement - Types of Sleep | REM Sleep, Baseline to Week 8 | 19.33 average percentage of total time in bed | Standard Deviation 3.86 |
| Ubiquinol | FitBit Sleep Measurement - Types of Sleep | Asleep, Week 16 to Week 24 | 88.81 average percentage of total time in bed | Standard Deviation 3.48 |
| Ubiquinol | FitBit Sleep Measurement - Types of Sleep | REM Sleep, Week 8 to Week 16 | 18.65 average percentage of total time in bed | Standard Deviation 4.38 |
| Ubiquinol | FitBit Sleep Measurement - Types of Sleep | Light Sleep, Week 8 to Week 16 | 67.31 average percentage of total time in bed | Standard Deviation 6.43 |
| Ubiquinol | FitBit Sleep Measurement - Types of Sleep | REM Sleep, Week 16 to Week 24 | 19.74 average percentage of total time in bed | Standard Deviation 3.98 |
| Ubiquinol | FitBit Sleep Measurement - Types of Sleep | Asleep, Baseline to Week 8 | 89.06 average percentage of total time in bed | Standard Deviation 2.61 |
| Placebo | FitBit Sleep Measurement - Types of Sleep | REM Sleep, Week 16 to Week 24 | 18.75 average percentage of total time in bed | Standard Deviation 4.59 |
| Placebo | FitBit Sleep Measurement - Types of Sleep | Asleep, Baseline to Week 8 | 88.57 average percentage of total time in bed | Standard Deviation 1.4 |
| Placebo | FitBit Sleep Measurement - Types of Sleep | Asleep, Week 8 to Week 16 | 88.5 average percentage of total time in bed | Standard Deviation 1.36 |
| Placebo | FitBit Sleep Measurement - Types of Sleep | Asleep, Week 16 to Week 24 | 88.85 average percentage of total time in bed | Standard Deviation 2.06 |
| Placebo | FitBit Sleep Measurement - Types of Sleep | Awake, Baseline to Week 8 | 11.34 average percentage of total time in bed | Standard Deviation 1.37 |
| Placebo | FitBit Sleep Measurement - Types of Sleep | Awake, Week 8 to Week 16 | 11.43 average percentage of total time in bed | Standard Deviation 1.92 |
| Placebo | FitBit Sleep Measurement - Types of Sleep | Awake, Week 16 to Week 24 | 11.09 average percentage of total time in bed | Standard Deviation 2.06 |
| Placebo | FitBit Sleep Measurement - Types of Sleep | Light Sleep, Baseline to Week 8 | 64.68 average percentage of total time in bed | Standard Deviation 7.21 |
| Placebo | FitBit Sleep Measurement - Types of Sleep | Light Sleep, Week 8 to Week 16 | 65.89 average percentage of total time in bed | Standard Deviation 7.1 |
| Placebo | FitBit Sleep Measurement - Types of Sleep | Light Sleep, Week 16 to Week 24 | 65.28 average percentage of total time in bed | Standard Deviation 7.98 |
| Placebo | FitBit Sleep Measurement - Types of Sleep | Deep Sleep, Baseline to Week 8 | 14.7 average percentage of total time in bed | Standard Deviation 5.97 |
| Placebo | FitBit Sleep Measurement - Types of Sleep | Deep Sleep, Week 8 to Week 16 | 13.82 average percentage of total time in bed | Standard Deviation 5.48 |
| Placebo | FitBit Sleep Measurement - Types of Sleep | Deep Sleep, Week 16 to Week 24 | 15.23 average percentage of total time in bed | Standard Deviation 5.86 |
| Placebo | FitBit Sleep Measurement - Types of Sleep | REM Sleep, Baseline to Week 8 | 6.41 average percentage of total time in bed | Standard Deviation 1.31 |
| Placebo | FitBit Sleep Measurement - Types of Sleep | REM Sleep, Week 8 to Week 16 | 20.21 average percentage of total time in bed | Standard Deviation 3.43 |
Secondary
Gulf War Illness Health Symptom Checklist
The Gulf War Illness Health Symptoms Checklist asks questions about symptoms related to Gulf War Illness. The linear scale is 0-42. The higher value indicates more symptoms.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, and 28
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | Gulf War Illness Health Symptom Checklist | Change from baseline to 12 weeks | -5.8 units on a scale | Standard Deviation 10.8 |
| Ubiquinol | Gulf War Illness Health Symptom Checklist | Change from baseline to 20 weeks | -6.1 units on a scale | Standard Deviation 11.9 |
| Ubiquinol | Gulf War Illness Health Symptom Checklist | Change from baseline to 8 weeks | -3.7 units on a scale | Standard Deviation 7.5 |
| Ubiquinol | Gulf War Illness Health Symptom Checklist | Change from baseline to 24 weeks | -3.8 units on a scale | Standard Deviation 8.6 |
| Ubiquinol | Gulf War Illness Health Symptom Checklist | Change from baseline to 16 weeks | -4.6 units on a scale | Standard Deviation 9.5 |
| Ubiquinol | Gulf War Illness Health Symptom Checklist | Change from baseline to 28 weeks | -8.7 units on a scale | Standard Deviation 11.5 |
| Ubiquinol | Gulf War Illness Health Symptom Checklist | Change from baseline to 4 weeks | -3.7 units on a scale | Standard Deviation 8.8 |
| Placebo | Gulf War Illness Health Symptom Checklist | Change from baseline to 28 weeks | -9.4 units on a scale | Standard Deviation 13.3 |
| Placebo | Gulf War Illness Health Symptom Checklist | Change from baseline to 4 weeks | -2.0 units on a scale | Standard Deviation 6.3 |
| Placebo | Gulf War Illness Health Symptom Checklist | Change from baseline to 8 weeks | -2.6 units on a scale | Standard Deviation 9.4 |
| Placebo | Gulf War Illness Health Symptom Checklist | Change from baseline to 12 weeks | -2.7 units on a scale | Standard Deviation 9.4 |
| Placebo | Gulf War Illness Health Symptom Checklist | Change from baseline to 16 weeks | -1.6 units on a scale | Standard Deviation 6.1 |
| Placebo | Gulf War Illness Health Symptom Checklist | Change from baseline to 20 weeks | -3.7 units on a scale | Standard Deviation 10.3 |
| Placebo | Gulf War Illness Health Symptom Checklist | Change from baseline to 24 weeks | -3.1 units on a scale | Standard Deviation 8 |
Secondary
Hamilton Anxiety Scale (HAM-A)
This measure allows the participant to rate levels of anxiety. The Hamilton Anxiety Scale is 0-56. The higher value indicates more anxiety.
Time frame: Baseline, Weeks 8, 16, and 24
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | Hamilton Anxiety Scale (HAM-A) | Change from baseline to 8 weeks | -0.9 units on a scale | Standard Deviation 9.3 |
| Ubiquinol | Hamilton Anxiety Scale (HAM-A) | Change from baseline to 16 weeks | -0.7 units on a scale | Standard Deviation 8.3 |
| Ubiquinol | Hamilton Anxiety Scale (HAM-A) | Change from baseline to 24 weeks | -1.5 units on a scale | Standard Deviation 9 |
| Placebo | Hamilton Anxiety Scale (HAM-A) | Change from baseline to 8 weeks | 1.7 units on a scale | Standard Deviation 10.3 |
| Placebo | Hamilton Anxiety Scale (HAM-A) | Change from baseline to 16 weeks | -1.7 units on a scale | Standard Deviation 8.3 |
| Placebo | Hamilton Anxiety Scale (HAM-A) | Change from baseline to 24 weeks | 0.1 units on a scale | Standard Deviation 10.3 |
Secondary
Hamilton Depression Scale (HAM-D)
This measure allows the participant to rate level of depression. The Hamilton Depression Scale is a linear scale 0-62. The higher value indicates more depression.
Time frame: Baseline, Weeks 8, 16, and 24
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | Hamilton Depression Scale (HAM-D) | Change from baseline to 8 weeks | -2.4 units on a scale | Standard Deviation 6.1 |
| Ubiquinol | Hamilton Depression Scale (HAM-D) | Change from baseline to 16 weeks | -2.8 units on a scale | Standard Deviation 5.8 |
| Ubiquinol | Hamilton Depression Scale (HAM-D) | Change from baseline to 24 weeks | -2.5 units on a scale | Standard Deviation 7 |
| Placebo | Hamilton Depression Scale (HAM-D) | Change from baseline to 8 weeks | -1.3 units on a scale | Standard Deviation 4.9 |
| Placebo | Hamilton Depression Scale (HAM-D) | Change from baseline to 16 weeks | -3.6 units on a scale | Standard Deviation 4.5 |
| Placebo | Hamilton Depression Scale (HAM-D) | Change from baseline to 24 weeks | -2.8 units on a scale | Standard Deviation 5.8 |
Secondary
Multidimensional Fatigue Inventory (MFI)
MFI asks questions about general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. The Multidimensional Fatigue Inventory score is 0-100. The higher value indicates more fatigue.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Population: Intention-to-Treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | Multidimensional Fatigue Inventory (MFI) | Change Baseline to 4 Weeks | -0.6 score on a scale | Standard Deviation 8.3 |
| Ubiquinol | Multidimensional Fatigue Inventory (MFI) | Change Baseline to 8 Weeks | -1.8 score on a scale | Standard Deviation 9.9 |
| Ubiquinol | Multidimensional Fatigue Inventory (MFI) | Change Baseline to 12 Weeks | -1.4 score on a scale | Standard Deviation 10 |
| Ubiquinol | Multidimensional Fatigue Inventory (MFI) | Change Baseline to 16 Weeks | -3.2 score on a scale | Standard Deviation 9.5 |
| Ubiquinol | Multidimensional Fatigue Inventory (MFI) | Change Baseline to 20 Weeks | -0.5 score on a scale | Standard Deviation 7.5 |
| Ubiquinol | Multidimensional Fatigue Inventory (MFI) | Change Baseline to 24 Weeks | -2.3 score on a scale | Standard Deviation 9.7 |
| Placebo | Multidimensional Fatigue Inventory (MFI) | Change Baseline to 20 Weeks | 2.5 score on a scale | Standard Deviation 9 |
| Placebo | Multidimensional Fatigue Inventory (MFI) | Change Baseline to 4 Weeks | 0.2 score on a scale | Standard Deviation 10 |
| Placebo | Multidimensional Fatigue Inventory (MFI) | Change Baseline to 16 Weeks | 0.3 score on a scale | Standard Deviation 8.1 |
| Placebo | Multidimensional Fatigue Inventory (MFI) | Change Baseline to 8 Weeks | 0.5 score on a scale | Standard Deviation 8 |
| Placebo | Multidimensional Fatigue Inventory (MFI) | Change Baseline to 24 Weeks | 0.8 score on a scale | Standard Deviation 8.7 |
| Placebo | Multidimensional Fatigue Inventory (MFI) | Change Baseline to 12 Weeks | 3.6 score on a scale | Standard Deviation 8.4 |
Secondary
Pittsburgh Sleep Quality Index
The PSQI measures quality and patterns of sleep and wake cycles and is completed by the participant. The Pittsburgh Sleep Quality Index scale is 0-21. The higher value indicates more sleep disturbance.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | Pittsburgh Sleep Quality Index | Change from baseline to 12 weeks | -1.7 units on a scale | Standard Deviation 3.4 |
| Ubiquinol | Pittsburgh Sleep Quality Index | Change from baseline to 16 weeks | -1.6 units on a scale | Standard Deviation 3 |
| Ubiquinol | Pittsburgh Sleep Quality Index | Change from baseline to 20 weeks | -0.3 units on a scale | Standard Deviation 3.7 |
| Ubiquinol | Pittsburgh Sleep Quality Index | Change from baseline to 8 weeks | -1.2 units on a scale | Standard Deviation 2.9 |
| Ubiquinol | Pittsburgh Sleep Quality Index | Change from baseline to 24 weeks | -1.4 units on a scale | Standard Deviation 3.5 |
| Ubiquinol | Pittsburgh Sleep Quality Index | Change from baseline to 4 weeks | -1.0 units on a scale | Standard Deviation 2.8 |
| Placebo | Pittsburgh Sleep Quality Index | Change from baseline to 24 weeks | -0.4 units on a scale | Standard Deviation 3.5 |
| Placebo | Pittsburgh Sleep Quality Index | Change from baseline to 4 weeks | 0.0 units on a scale | Standard Deviation 3.1 |
| Placebo | Pittsburgh Sleep Quality Index | Change from baseline to 8 weeks | -0.4 units on a scale | Standard Deviation 2.8 |
| Placebo | Pittsburgh Sleep Quality Index | Change from baseline to 12 weeks | 0.1 units on a scale | Standard Deviation 3.6 |
| Placebo | Pittsburgh Sleep Quality Index | Change from baseline to 20 weeks | 0.3 units on a scale | Standard Deviation 3.7 |
| Placebo | Pittsburgh Sleep Quality Index | Change from baseline to 16 weeks | -1.0 units on a scale | Standard Deviation 3 |
Secondary
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hematocrit
Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: percentages of hematocrit in blood. Average values fell within the normal range for this type of assay.
Time frame: Baseline, Weeks 8, 16, and 24
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hematocrit | Change from baseline to 8 weeks | 0.73 percentage of red blood cells in blood | Standard Deviation 4.64 |
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hematocrit | Change from baseline to 16 weeks | 0.63 percentage of red blood cells in blood | Standard Deviation 4.94 |
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hematocrit | Change from baseline to 24 weeks | 0.53 percentage of red blood cells in blood | Standard Deviation 4.77 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hematocrit | Change from baseline to 16 weeks | -0.27 percentage of red blood cells in blood | Standard Deviation 3.41 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hematocrit | Change from baseline to 8 weeks | 0.11 percentage of red blood cells in blood | Standard Deviation 2.58 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hematocrit | Change from baseline to 24 weeks | -0.25 percentage of red blood cells in blood | Standard Deviation 3.08 |
Secondary
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hemoglobin
Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: hemoglobin. Average values fell within the normal range for this type of assay.
Time frame: Baseline, Weeks 8, 16, and 24
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hemoglobin | Change from baseline to 8 weeks | 0.18 grams per deciliter | Standard Deviation 1.56 |
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hemoglobin | Change from baseline to 16 weeks | 0.17 grams per deciliter | Standard Deviation 1.59 |
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hemoglobin | Change from baseline to 24 weeks | 0.10 grams per deciliter | Standard Deviation 1.52 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hemoglobin | Change from baseline to 8 weeks | 0.05 grams per deciliter | Standard Deviation 0.8 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hemoglobin | Change from baseline to 16 weeks | -0.25 grams per deciliter | Standard Deviation 0.91 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Hemoglobin | Change from baseline to 24 weeks | -0.28 grams per deciliter | Standard Deviation 1.11 |
Secondary
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Red Blood Cell (RBC) Counts
Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: red blood cell counts. Average values fell within the normal range for this type of assay.
Time frame: Baseline, Weeks 8, 16, and 24
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Red Blood Cell (RBC) Counts | RBC, Change from baseline to 8 weeks | 0.10 1000000 cells per microliter | Standard Deviation 0.64 |
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Red Blood Cell (RBC) Counts | RBC, Change from baseline to 16 weeks | 0.12 1000000 cells per microliter | Standard Deviation 0.7 |
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Red Blood Cell (RBC) Counts | RBC, Change from baseline to 24 weeks | 0.08 1000000 cells per microliter | Standard Deviation 0.69 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Red Blood Cell (RBC) Counts | RBC, Change from baseline to 8 weeks | 0.01 1000000 cells per microliter | Standard Deviation 0.27 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Red Blood Cell (RBC) Counts | RBC, Change from baseline to 16 weeks | -0.03 1000000 cells per microliter | Standard Deviation 0.33 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) Red Blood Cell (RBC) Counts | RBC, Change from baseline to 24 weeks | -0.02 1000000 cells per microliter | Standard Deviation 0.32 |
Secondary
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets
Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: white blood cell (WBC) counts and platelets. Average values fell within the normal range for this type of assay.
Time frame: Baseline, Weeks 8, 16, and 24
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets | WBC, Change from baseline to 8 weeks | 0.41 1000 cells per microliter | Standard Deviation 2.63 |
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets | WBC, Change from baseline to 16 weeks | 0.22 1000 cells per microliter | Standard Deviation 2.54 |
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets | WBC, Change from baseline to 24 weeks | 0.22 1000 cells per microliter | Standard Deviation 2.81 |
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets | Platelets, Change from baseline to 8 weeks | -0.94 1000 cells per microliter | Standard Deviation 74.64 |
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets | Platelets, Change from baseline to 16 weeks | -5.88 1000 cells per microliter | Standard Deviation 79.94 |
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets | Platelets, Change from baseline to 24 weeks | -6.00 1000 cells per microliter | Standard Deviation 78.07 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets | Platelets, Change from baseline to 16 weeks | 3.74 1000 cells per microliter | Standard Deviation 31.36 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets | WBC, Change from baseline to 8 weeks | 0.34 1000 cells per microliter | Standard Deviation 1.27 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets | Platelets, Change from baseline to 8 weeks | -2.00 1000 cells per microliter | Standard Deviation 26.2 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets | WBC, Change from baseline to 16 weeks | 0.14 1000 cells per microliter | Standard Deviation 1.27 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets | Platelets, Change from baseline to 24 weeks | 14.48 1000 cells per microliter | Standard Deviation 48.81 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Counts and Platelets | WBC, Change from baseline to 24 weeks | 0.44 1000 cells per microliter | Standard Deviation 1.44 |
Secondary
Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages
Peripheral blood biomarker levels are quantified by complete blood count (CBC) analyses: percentages of white blood cells. Average values fell within the normal range for this type of assay.
Time frame: Baseline, Weeks 8, 16, and 24
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Lymphocytes, Change from baseline to 16 weeks | -0.18 percentage of white blood cells | Standard Deviation 12.73 |
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Monocytes, Change from baseline to 24 weeks | -0.23 percentage of white blood cells | Standard Deviation 2.88 |
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Neutrophils, Change from baseline to 16 weeks | 0.26 percentage of white blood cells | Standard Deviation 13.97 |
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Eosinophils, Change from baseline to 8 weeks | -0.25 percentage of white blood cells | Standard Deviation 2.86 |
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Lymphocytes, Change from baseline to 24 weeks | -3.01 percentage of white blood cells | Standard Deviation 13.22 |
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Eosinophils, Change from baseline to 16 weeks | 0.07 percentage of white blood cells | Standard Deviation 2.56 |
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Lymphocytes, Change from baseline to 8 weeks | -1.64 percentage of white blood cells | Standard Deviation 12.29 |
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Eosinophils, Change from baseline to 24 weeks | -0.16 percentage of white blood cells | Standard Deviation 2.67 |
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Monocytes, Change from baseline to 8 weeks | -0.19 percentage of white blood cells | Standard Deviation 3.68 |
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Basophils, Change from baseline to 8 weeks | -0.02 percentage of white blood cells | Standard Deviation 0.69 |
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Neutrophils, Change from baseline to 24 weeks | 3.33 percentage of white blood cells | Standard Deviation 14.81 |
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Basophils, Change from baseline to 16 weeks | 0.23 percentage of white blood cells | Standard Deviation 0.54 |
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Monocytes, Change from baseline to 16 weeks | -0.43 percentage of white blood cells | Standard Deviation 2.81 |
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Basophils, Change from baseline to 24 weeks | 0.00 percentage of white blood cells | Standard Deviation 0.64 |
| Ubiquinol | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Neutrophils, Change from baseline to 8 weeks | 2.08 percentage of white blood cells | Standard Deviation 15.11 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Basophils, Change from baseline to 24 weeks | 0.07 percentage of white blood cells | Standard Deviation 0.87 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Neutrophils, Change from baseline to 8 weeks | 1.13 percentage of white blood cells | Standard Deviation 9.25 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Neutrophils, Change from baseline to 16 weeks | 0.74 percentage of white blood cells | Standard Deviation 9.36 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Neutrophils, Change from baseline to 24 weeks | 2.04 percentage of white blood cells | Standard Deviation 10.95 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Lymphocytes, Change from baseline to 8 weeks | -0.39 percentage of white blood cells | Standard Deviation 7.83 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Lymphocytes, Change from baseline to 16 weeks | 0.10 percentage of white blood cells | Standard Deviation 7.66 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Lymphocytes, Change from baseline to 24 weeks | -1.01 percentage of white blood cells | Standard Deviation 8.68 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Monocytes, Change from baseline to 8 weeks | -0.37 percentage of white blood cells | Standard Deviation 2.36 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Monocytes, Change from baseline to 16 weeks | -0.12 percentage of white blood cells | Standard Deviation 1.61 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Monocytes, Change from baseline to 24 weeks | -0.39 percentage of white blood cells | Standard Deviation 1.95 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Eosinophils, Change from baseline to 8 weeks | -0.30 percentage of white blood cells | Standard Deviation 1.35 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Eosinophils, Change from baseline to 16 weeks | -0.82 percentage of white blood cells | Standard Deviation 1.86 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Eosinophils, Change from baseline to 24 weeks | -0.67 percentage of white blood cells | Standard Deviation 2.13 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Basophils, Change from baseline to 8 weeks | -0.06 percentage of white blood cells | Standard Deviation 0.75 |
| Placebo | Response to Therapy of Gulf War Illness-associated Peripheral Blood Biomarkers - Complete Blood Count (CBC) White Blood Cell Percentages | Basophils, Change from baseline to 16 weeks | 0.14 percentage of white blood cells | Standard Deviation 0.64 |
Secondary
Response to Therapy on Cortisol Levels
Cortisol will be measured using a 24-hour salivary collection to assess circadian rhythm.
Time frame: Baseline, Weeks 8, 16, and 24 upon waking, mid-morning, evening, and sleep for each.
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | Response to Therapy on Cortisol Levels | Morning, Change from Baseline to Week 16 | 0.12 micrograms/dL | Standard Deviation 0.53 |
| Ubiquinol | Response to Therapy on Cortisol Levels | Evening, Change from Baseline to Week 8 | -0.02 micrograms/dL | Standard Deviation 0.15 |
| Ubiquinol | Response to Therapy on Cortisol Levels | Evening, Change from Baseline to Week 16 | 0.03 micrograms/dL | Standard Deviation 0.21 |
| Ubiquinol | Response to Therapy on Cortisol Levels | Evening, Change from Baseline to Week 24 | -0.01 micrograms/dL | Standard Deviation 0.16 |
| Ubiquinol | Response to Therapy on Cortisol Levels | Sleep, Change from Baseline to Week 16 | 0.11 micrograms/dL | Standard Deviation 0.21 |
| Ubiquinol | Response to Therapy on Cortisol Levels | Sleep, Change from Baseline to Week 8 | 0.03 micrograms/dL | Standard Deviation 0.17 |
| Ubiquinol | Response to Therapy on Cortisol Levels | Waking, Change from Baseline to Week 24 | 0.06 micrograms/dL | Standard Deviation 0.24 |
| Ubiquinol | Response to Therapy on Cortisol Levels | Morning, Change from Baseline to Week 8 | 0.04 micrograms/dL | Standard Deviation 0.1 |
| Ubiquinol | Response to Therapy on Cortisol Levels | Morning, Change from Baseline to Week 24 | 0.02 micrograms/dL | Standard Deviation 0.16 |
| Ubiquinol | Response to Therapy on Cortisol Levels | Waking, Change from Baseline to Week 16 | 0.08 micrograms/dL | Standard Deviation 0.63 |
| Ubiquinol | Response to Therapy on Cortisol Levels | Sleep, Change from Baseline to Week 24 | 0.01 micrograms/dL | Standard Deviation 0.15 |
| Ubiquinol | Response to Therapy on Cortisol Levels | Waking, Change from Baseline to Week 8 | -0.04 micrograms/dL | Standard Deviation 0.32 |
| Placebo | Response to Therapy on Cortisol Levels | Sleep, Change from Baseline to Week 24 | -0.02 micrograms/dL | Standard Deviation 0.11 |
| Placebo | Response to Therapy on Cortisol Levels | Waking, Change from Baseline to Week 8 | -0.04 micrograms/dL | Standard Deviation 0.28 |
| Placebo | Response to Therapy on Cortisol Levels | Morning, Change from Baseline to Week 8 | 0.10 micrograms/dL | Standard Deviation 0.49 |
| Placebo | Response to Therapy on Cortisol Levels | Evening, Change from Baseline to Week 8 | 0.05 micrograms/dL | Standard Deviation 0.19 |
| Placebo | Response to Therapy on Cortisol Levels | Sleep, Change from Baseline to Week 8 | 0.05 micrograms/dL | Standard Deviation 0.23 |
| Placebo | Response to Therapy on Cortisol Levels | Waking, Change from Baseline to Week 16 | 0.02 micrograms/dL | Standard Deviation 0.29 |
| Placebo | Response to Therapy on Cortisol Levels | Morning, Change from Baseline to Week 16 | -0.02 micrograms/dL | Standard Deviation 0.09 |
| Placebo | Response to Therapy on Cortisol Levels | Evening, Change from Baseline to Week 16 | 0.05 micrograms/dL | Standard Deviation 0.21 |
| Placebo | Response to Therapy on Cortisol Levels | Sleep, Change from Baseline to Week 16 | 0.01 micrograms/dL | Standard Deviation 0.13 |
| Placebo | Response to Therapy on Cortisol Levels | Waking, Change from Baseline to Week 24 | 0.03 micrograms/dL | Standard Deviation 0.17 |
| Placebo | Response to Therapy on Cortisol Levels | Evening, Change from Baseline to Week 24 | 0.00 micrograms/dL | Standard Deviation 0.12 |
| Placebo | Response to Therapy on Cortisol Levels | Morning, Change from Baseline to Week 24 | 0.03 micrograms/dL | Standard Deviation 0.12 |
Secondary
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Estradiol
HPG will measure estradiol. Average values fell within the normal range for this type of assay.
Time frame: Baseline, Weeks 8, 16, and 24
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Estradiol | Change from Baseline to Week 24 | 6.21 pg/mL | Standard Deviation 27.9 |
| Ubiquinol | Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Estradiol | Change from Baseline to Week 8 | 6.06 pg/mL | Standard Deviation 25.64 |
| Ubiquinol | Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Estradiol | Change from Baseline to Week 16 | -0.97 pg/mL | Standard Deviation 11.86 |
| Placebo | Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Estradiol | Change from Baseline to Week 16 | -1.37 pg/mL | Standard Deviation 6.55 |
| Placebo | Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Estradiol | Change from Baseline to Week 8 | 1.77 pg/mL | Standard Deviation 7.51 |
| Placebo | Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Estradiol | Change from Baseline to Week 24 | -2.19 pg/mL | Standard Deviation 8.79 |
Secondary
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Progesterone
HPG will measure progesterone. Average values fell within the normal range for this type of assay.
Time frame: Baseline, Weeks 8, 16, and 24
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Progesterone | Change from Baseline to Week 8 | 0.01 ng/mL | Standard Deviation 0.16 |
| Ubiquinol | Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Progesterone | Change from Baseline to Week 16 | -0.00 ng/mL | Standard Deviation 0.16 |
| Ubiquinol | Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Progesterone | Change from Baseline to Week 24 | -0.02 ng/mL | Standard Deviation 0.13 |
| Placebo | Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Progesterone | Change from Baseline to Week 8 | 0.00 ng/mL | Standard Deviation 0.09 |
| Placebo | Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Progesterone | Change from Baseline to Week 16 | -0.03 ng/mL | Standard Deviation 0.08 |
| Placebo | Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Progesterone | Change from Baseline to Week 24 | -0.05 ng/mL | Standard Deviation 0.06 |
Secondary
Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Testosterone
HPG will measure testosterone. Average values fell within the normal range for this type of assay.
Time frame: Baseline, Weeks 8, 16, and 24
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Testosterone | Change from Baseline to Week 8 | -0.12 ng/mL | Standard Deviation 2.04 |
| Ubiquinol | Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Testosterone | Change from Baseline to Week 16 | -0.19 ng/mL | Standard Deviation 1.99 |
| Ubiquinol | Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Testosterone | Change from Baseline to Week 24 | -0.13 ng/mL | Standard Deviation 2.08 |
| Placebo | Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Testosterone | Change from Baseline to Week 8 | -0.14 ng/mL | Standard Deviation 0.95 |
| Placebo | Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Testosterone | Change from Baseline to Week 16 | -0.39 ng/mL | Standard Deviation 0.75 |
| Placebo | Response to Therapy on Hypothalamic-Pituitary-Gonadal (HPG) Axis: Testosterone | Change from Baseline to Week 24 | -0.53 ng/mL | Standard Deviation 1.3 |
Secondary
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT3
Thyroid status is assessed using a chemiluminescent method: Free triiodothyronine (FT3). Average values fell within the normal range for this type of assay.
Time frame: Baseline, Weeks 8, 16, and 24
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT3 | Change from Baseline to Week 8 | -0.06 pg/mL | Standard Deviation 0.48 |
| Ubiquinol | Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT3 | Change from Baseline to Week 16 | -0.13 pg/mL | Standard Deviation 0.48 |
| Ubiquinol | Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT3 | Change from Baseline to Week 24 | -0.05 pg/mL | Standard Deviation 0.56 |
| Placebo | Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT3 | Change from Baseline to Week 8 | -0.04 pg/mL | Standard Deviation 0.29 |
| Placebo | Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT3 | Change from Baseline to Week 16 | -0.10 pg/mL | Standard Deviation 0.32 |
| Placebo | Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT3 | Change from Baseline to Week 24 | -0.17 pg/mL | Standard Deviation 0.4 |
Secondary
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT4
Thyroid status is assessed using a chemiluminescent method: Free thyroxine (FT4). Average values fell within the normal range for this type of assay.
Time frame: Baseline, Weeks 8, 16, and 24
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT4 | Change from Baseline to Week 8 | -0.00 ng/dL | Standard Deviation 0.21 |
| Ubiquinol | Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT4 | Change from Baseline to Week 16 | -0.01 ng/dL | Standard Deviation 0.19 |
| Ubiquinol | Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT4 | Change from Baseline to Week 24 | -0.02 ng/dL | Standard Deviation 0.18 |
| Placebo | Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT4 | Change from Baseline to Week 8 | -0.03 ng/dL | Standard Deviation 0.11 |
| Placebo | Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT4 | Change from Baseline to Week 16 | -0.02 ng/dL | Standard Deviation 0.1 |
| Placebo | Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: FT4 | Change from Baseline to Week 24 | -0.06 ng/dL | Standard Deviation 0.12 |
Secondary
Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: TSH
Thyroid status is assessed using a chemiluminescent method: thyroid stimulating hormone (TSH). Average values fell within the normal range for this type of assay.
Time frame: Baseline, Weeks 8, 16, and 24
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: TSH | Change from Baseline to Week 8 | 0.344 mIU/L | Standard Deviation 1.26 |
| Ubiquinol | Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: TSH | Change from Baseline to Week 16 | 0.15 mIU/L | Standard Deviation 1.31 |
| Ubiquinol | Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: TSH | Change from Baseline to Week 24 | -0.10 mIU/L | Standard Deviation 1.23 |
| Placebo | Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: TSH | Change from Baseline to Week 8 | 0.09 mIU/L | Standard Deviation 0.96 |
| Placebo | Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: TSH | Change from Baseline to Week 16 | -0.06 mIU/L | Standard Deviation 0.68 |
| Placebo | Response to Therapy on Hypothalamic-Pituitary-Thyroid (HPT) Axis: TSH | Change from Baseline to Week 24 | -0.04 mIU/L | Standard Deviation 0.92 |
Secondary
Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS)
Veterans Health Survey contains 36 items to measure health functioning from the patient's point of view. The Veterans Short Form 36-item Health Survey Mental Component Score scale is 0-100. The higher value indicates more favorable mental health.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Population: Intention-to-treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ubiquinol | Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS) | Change from baseline to 4 weeks | 4.5 score on a scale | Standard Deviation 12.6 |
| Ubiquinol | Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS) | Change from baseline to 8 weeks | 4.2 score on a scale | Standard Deviation 14.9 |
| Ubiquinol | Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS) | Change from baseline to 12 weeks | 4.0 score on a scale | Standard Deviation 19.5 |
| Ubiquinol | Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS) | Change from baseline to 16 weeks | 3.8 score on a scale | Standard Deviation 15.5 |
| Ubiquinol | Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS) | Change from baseline to 20 weeks | -3.7 score on a scale | Standard Deviation 17.4 |
| Ubiquinol | Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS) | Change from baseline to 24 weeks | 2.6 score on a scale | Standard Deviation 16.3 |
| Placebo | Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS) | Change from baseline to 20 weeks | 3.1 score on a scale | Standard Deviation 15.8 |
| Placebo | Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS) | Change from baseline to 4 weeks | 0.4 score on a scale | Standard Deviation 12.8 |
| Placebo | Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS) | Change from baseline to 16 weeks | 4.9 score on a scale | Standard Deviation 13.9 |
| Placebo | Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS) | Change from baseline to 8 weeks | 3.6 score on a scale | Standard Deviation 14.8 |
| Placebo | Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS) | Change from baseline to 24 weeks | 1.1 score on a scale | Standard Deviation 13.5 |
| Placebo | Veterans Short Form 36-Item Health Survey: Mental Component Score (MCS) | Change from baseline to 12 weeks | 2.8 score on a scale | Standard Deviation 10.6 |