Exercise Recovery, Muscle Fatigue, Muscle Pain, Post Exercise Inflammation
Conditions
Brief summary
This is a double blind, randomised, placebo-controlled, parallel-group trial to evaluate the effect of Maolactin FMR supplementation on post exercise inflammation, exercise recovery and muscle fatigue and pain in an otherwise healthy population of adults 18-65 years old over 10 weeks with 8 weeks of supplementation. This is PART A of the study.
Interventions
DRUGMaolactin
Once daily dose of 2 capsules containing a total of 500mg/day Maolactin
DRUGMaltodextrin
Once daily dose of 2 capsules of Maltodextrin containing a total of 0mg/day Maolactin
Sponsors
RDC Clinical Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults 18-65 years old * Generally healthy * BMI 19.0 - 29.9 kg/m2 * Able to provide informed consent * Generally active, low to moderately trained (with a minimum of 1 resistance exercise sessions per week) * Agree not to change current diet and/or exercise frequency or intensity during study period * Agree to not participate in another clinical trial while enrolled in this trial
Exclusion criteria
* Undertaking high intensity exercise training and or undertaking more than 3 days of resistance training per week. * Serious illness(1) e.g., mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease or heart conditions * Unstable illness(2) e.g., diabetes and thyroid gland dysfunction * Unstable intake of any medication or supplement(3) * Acute injuries on reporting area * Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years * Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy including low dose aspirin * Receiving medications known to affect inflammation such as steroids * Active smokers, nicotine use or drug (prescription or illegal substances) abuse * Chronic past and/or current alcohol use (\>21 alcoholic drinks per week) * Pregnant or lactating women * Allergic to any of the ingredients in active or placebo formula * Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month * Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion 1. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments. 2. An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. 3. An unstable intake is any dose that has changed by more than 10% of the previous dose in the past 4-weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in post exercise muscle breakdown | Baseline (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise) and Week 8 (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise) | Change in post exercise muscle breakdown as assessed by creatine kinase (CK) via blood test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index (BMI) | Baseline and Week 8 | Change in BMI as assessed by digital scale for weight and stadiometer for height |
| Change in Musculoskeletal Health Questionnaire (MSK-HQ) | Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) | Change in MSK-HQ as self-reported by participants. Scored on a range of 0-56, with a higher score indicating health status. |
| Change in Visual Analogue Scale (VAS) Muscle Pain | Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) | Change in VAS Muscle Pain as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of muscle pain. |
| Change in Visual Analogue Scale (VAS) Pain | Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) | Change in VAS Pain as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of pain |
| Change in Visual Analogue Scale (VAS) Fatigue | Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) | Change in VAS Fatigue as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of fatigue. |
| Change in Visual Analogue Scale (VAS) Mobility | Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) | Change in VAS Mobility as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of mobility. |
| Change in Visual Analogue Scale (VAS) Stiffness | Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) | Change in VAS Stiffness as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of stiffness. |
| Change in Multidimensional Fatigue Inventory (MFI) | Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) | Change in MFI as self-reported by participants. Comprises 20 questions rated on a 5 point scale. with a higher score indicating a higher level of fatigue. |
| Change in The Perceived Recovery Status Scale (PRSS) | Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) | Change in PRSS as self-reported by participants. A single-item, 0 to 10 point scale where 0 = very poorly recovered (poor performance) and 10 = fully recovered (optimal performance). |
| Change in Blood Pressure (BP) | Baseline and Week 8 | Change in BP as assessed by digital blood pressure monitor |
| Change in Heart Rate (HR) | Baseline (Time 0 and every 5 minutes until return to baseline) and Week 8 (Time 0 and every 5 minutes until return to baseline) | Change in HR as assessed by digital heart rate monitor |
| Change in Oxygen Saturation | Baseline and Week 8 | Change in Oxygen Saturation as measured by pulse oximeter |
| Change in Cytokines | Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post) | Change in Cytokines as measured by blood test |
| Change in Nuclear Factor KappaB (NF-kB) | Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post) | Change in NF-kB as measured by blood test |
| Change in P-selectin | Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post) | Change in P-selectin as measured by blood test |
| Change in E-selectin | Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post) | Change in E-selectin as measured by blood test |
| Change in Lipoprotein-associated Phospholipase A2 (Lp-PLA2) | Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post) | Change in Lp-PLA2 as measured by blood test |
| Change in Weight | Baseline and Week 8 | Change in Weight as measured by digital scales |
| Change in Intercellular Cell Adhesion Molecule-2 (ICAM-2) | Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post) | Change in ICAM-2 as measured by blood test |
| Change in Vascular Cell Adhesion Molecule-1 (VCAM-1) | Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post) | Change in VCAM-1 as measured by blood test |
| Change in Platelet Endothelial Cell Adhesion Molecule-1 (PECAM-1) | Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post) | Change in PECAM-1 as measured by blood test |
| Change in Erythrocyte Sedimentation Rate (ESR) | Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post) | Change in ESR as measured by blood test |
| Change in Lactate Dehydrogenase (LDH) | Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post) | Change in LDH as measured by blood test |
| Change in P38 Mitogen-activated Protein Kinases (P38) | Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post) | Change in P38 as measured by blood test |
| Change in Electrolytes and Liver Function Tests (E/LFT) | Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post) | Change in E/LFT as measured by blood test |
| Change in Lactic acid | Baseline (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise) and Week 8 (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise) | Change in Lactic acid as measured by blood test |
| Change in C-reactive protein (CRP) | Baseline (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise) and Week 8 (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise) | Change in CRP as measured by blood test |
| Change in myoglobin | Baseline (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise) and Week 8 (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise) | Change in myoglobin as measured by blood test |
| Change in 1 Repetition Max (1-RM) | Baseline (Session 1 and Session 2 (+24 hours)) and Week 8 (Session 1, Session 2 (+24 hours)) | Change in 1 Repetition Max (1-RM) as assessed by exercise testing |
| Change in Number of Repetitions to Fatigue | Baseline (Session 1 and Session 2 (+24 hours)) and Week 8 (Session 1, Session 2 (+24 hours) | Change in Number of Repetitions to Fatigue as assessed by exercise testing |
| Change in Hand Grip Strength | Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) | Change in Hand Grip Strength as measured by dynamometer |
| Change in BORG Perception of intensity (RPE) | Baseline (Session 1 and Session 2 (+24 hours)) and Week 8 (Session 1, Session 2 (+24 hours) | Change in BORG Perception of intensity (RPE) as self-reported by participants. Rates exertion from a scale of 6 (no exertion) to 20 (maximum effort). A rating between 12 to 14 typically reflects a moderate or somewhat hard level of intensity. |
| Change in Adverse Events | 8 week period from enrolment to participant conclusion | Change in Adverse Events self-reported by participants |
| Change in Gastrointestinal Tolerance | 1 week after starting product | Change in Gastrointestinal Tolerance as measured by Gastrointestinal Tolerance (GIT) Questionnaire |
| Change in diet | Baseline and Week 8 | Change in diet as assessed by 3 day Diet Recall |
| Change in Intercellular Cell Adhesion Molecule-1 (ICAM-1) | Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post) | Change in ICAM-1 as measured by blood test |
Countries
Australia
Outcome results
None listed