Effect of Maolactin™ FMR on Exercise Recovery, Inflammation, and Muscle Comfort in an Otherwise Healthy Population

Phase 3

Recruiting

• Conditions: Muscle Fatigue; Post Exercise Inflammation; Exercise Recovery; Muscle Pain
• Interventions: Drug: Maolactin; Drug: Maltodextrin

• Registration Number: NCT06436781
• Lead Sponsor: RDC Clinical Pty Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-24
• Study First Submitted QC: 2024-05-24
• Study First Posted: 2024-05-31
• Study Start: 2024-09-12
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-05-30
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maolactin	Maolactin	2 capsules containing a total of 500 mg/day active proteins taken once daily before the morning meal
Maltodextrin	Maltodextrin	2 capsules containing maltodextrin (0mg/day active proteins) taken once daily before the morning meal

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 diet	Baseline and Week 8	Change in diet as assessed by 3 day Diet Recall
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 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) 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 Weight	Baseline and Week 8	Change in Weight as measured by digital scales
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 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 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 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 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 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 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 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 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 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
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 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 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 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 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 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 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 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.

Trial Locations

Locations (1)

RDC Clinical Pty Ltd; 🇦🇺 Brisbane, Queensland, Australia