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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maolactin | Experimental | 2 capsules containing a total of 500 mg/day active proteins taken once daily before the morning meal |
|
| Maltodextrin | Placebo Comparator | 2 capsules containing maltodextrin (0mg/day active proteins) taken once daily before the morning meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maolactin | Drug | Once daily dose of 2 capsules containing a total of 500mg/day Maolactin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in post exercise muscle breakdown | Change in post exercise muscle breakdown as assessed by creatine kinase (CK) via blood test | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight | Change in Weight as measured by digital scales | Baseline and Week 8 |
| Change in Body Mass Index (BMI) | Change in BMI as assessed by digital scale for weight and stadiometer for height |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| David Briskey, PhD | RDC Clinical Pty Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RDC Clinical Pty Ltd | Brisbane | Queensland | 4006 | Australia |
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| ID | Term |
|---|---|
| D063806 | Myalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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| Maltodextrin |
| Drug |
Once daily dose of 2 capsules of Maltodextrin containing a total of 0mg/day Maolactin |
|
| Baseline and Week 8 |
| Change in Musculoskeletal Health Questionnaire (MSK-HQ) | Change in MSK-HQ as self-reported by participants. Scored on a range of 0-56, with a higher score indicating health status. | 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 Visual Analogue Scale (VAS) Muscle Pain | 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. | 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 Visual Analogue Scale (VAS) Pain | Change in VAS Pain as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of 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 Visual Analogue Scale (VAS) Fatigue | Change in VAS Fatigue as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of 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 Visual Analogue Scale (VAS) Mobility | Change in VAS Mobility as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of 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 Visual Analogue Scale (VAS) Stiffness | Change in VAS Stiffness as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of 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 Multidimensional Fatigue Inventory (MFI) | 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. | 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 The Perceived Recovery Status Scale (PRSS) | 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). | 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 Blood Pressure (BP) | Change in BP as assessed by digital blood pressure monitor | Baseline and Week 8 |
| Change in Heart Rate (HR) | Change in HR as assessed by digital heart rate monitor | 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 Oxygen Saturation | Change in Oxygen Saturation as measured by pulse oximeter | Baseline and Week 8 |
| Change in Cytokines | Change in Cytokines as measured by blood test | Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post) |
| Change in Nuclear Factor KappaB (NF-kB) | Change in NF-kB as measured by blood test | Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post) |
| Change in P-selectin | Change in P-selectin as measured by blood test | Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post) |
| Change in E-selectin | Change in E-selectin as measured by blood test | Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post) |
| Change in Lipoprotein-associated Phospholipase A2 (Lp-PLA2) | Change in Lp-PLA2 as measured by blood test | Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post) |
| Change in Intercellular Cell Adhesion Molecule-1 (ICAM-1) | Change in ICAM-1 as measured by blood test | Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post) |
| Change in Intercellular Cell Adhesion Molecule-2 (ICAM-2) | Change in ICAM-2 as measured by blood test | Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post) |
| Change in Vascular Cell Adhesion Molecule-1 (VCAM-1) | Change in VCAM-1 as measured by blood test | Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post) |
| Change in Platelet Endothelial Cell Adhesion Molecule-1 (PECAM-1) | Change in PECAM-1 as measured by blood test | Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post) |
| Change in Erythrocyte Sedimentation Rate (ESR) | Change in ESR as measured by blood test | Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post) |
| Change in Lactate Dehydrogenase (LDH) | Change in LDH as measured by blood test | Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post) |
| Change in P38 Mitogen-activated Protein Kinases (P38) | Change in P38 as measured by blood test | Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post) |
| Change in Electrolytes and Liver Function Tests (E/LFT) | Change in E/LFT as measured by blood test | Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post) |
| Change in Lactic acid | Change in Lactic acid as measured by blood test | 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 C-reactive protein (CRP) | Change in CRP as measured by blood test | 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 | Change in myoglobin as measured by blood test | 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 1 Repetition Max (1-RM) | Change in 1 Repetition Max (1-RM) as assessed by exercise testing | Baseline (Session 1 and Session 2 (+24 hours)) and Week 8 (Session 1, Session 2 (+24 hours)) |
| Change in Number of Repetitions to Fatigue | Change in Number of Repetitions to Fatigue as assessed by exercise testing | Baseline (Session 1 and Session 2 (+24 hours)) and Week 8 (Session 1, Session 2 (+24 hours) |
| Change in Hand Grip Strength | Change in Hand Grip Strength as measured by dynamometer | 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 BORG Perception of intensity (RPE) | 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. | Baseline (Session 1 and Session 2 (+24 hours)) and Week 8 (Session 1, Session 2 (+24 hours) |
| Change in Adverse Events | Change in Adverse Events self-reported by participants | 8 week period from enrolment to participant conclusion |
| Change in Gastrointestinal Tolerance | Change in Gastrointestinal Tolerance as measured by Gastrointestinal Tolerance (GIT) Questionnaire | 1 week after starting product |
| Change in diet | Change in diet as assessed by 3 day Diet Recall | Baseline and Week 8 |
| D059352 | Musculoskeletal Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |