Muscle Fatigue Clinical Trial
Official title:
Effect of Maolactin™ FMR Supplementation on Exercise Recovery, Inflammation, and Muscle Comfort in an Otherwise Healthy Population: A Double-blind Randomized Placebo-controlled Study
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | July 31, 2025 |
Est. primary completion date | April 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Australia | RDC Clinical Pty Ltd | Brisbane | Queensland |
Lead Sponsor | Collaborator |
---|---|
RDC Clinical Pty Ltd |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Secondary | Change in Weight | Change in Weight as measured by digital scales | Baseline and Week 8 | |
Secondary | Change in Body Mass Index (BMI) | Change in BMI as assessed by digital scale for weight and stadiometer for height | Baseline and Week 8 | |
Secondary | 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)) | |
Secondary | 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)) | |
Secondary | 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)) | |
Secondary | 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)) | |
Secondary | 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)) | |
Secondary | 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)) | |
Secondary | 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)) | |
Secondary | 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)) | |
Secondary | Change in Blood Pressure (BP) | Change in BP as assessed by digital blood pressure monitor | Baseline and Week 8 | |
Secondary | 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) | |
Secondary | Change in Oxygen Saturation | Change in Oxygen Saturation as measured by pulse oximeter | Baseline and Week 8 | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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)) | |
Secondary | 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) | |
Secondary | 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)) | |
Secondary | 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) | |
Secondary | Change in Adverse Events | Change in Adverse Events self-reported by participants | 8 week period from enrolment to participant conclusion | |
Secondary | Change in Gastrointestinal Tolerance | Change in Gastrointestinal Tolerance as measured by Gastrointestinal Tolerance (GIT) Questionnaire | 1 week after starting product | |
Secondary | Change in diet | Change in diet as assessed by 3 day Diet Recall | Baseline and Week 8 |
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