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Completed

NCT Number: NCT06436781

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

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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Key information

Conditions

Post Exercise Inflammation Exercise Recovery Muscle Fatigue Muscle Pain Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

RDC Clinical Pty Ltd

Brisbane, Queensland, 4006, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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.
  • An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity.
  • An unstable intake is any dose that has changed by more than 10% of the previous dose in the past 4-weeks

Treatment and study plan

Maolactin

Drug

Once daily dose of 2 capsules containing a total of 500mg/day Maolactin

Maltodextrin

Drug

Once daily dose of 2 capsules of Maltodextrin containing a total of 0mg/day Maolactin

Primary outcomes

  1. Change in post exercise muscle breakdown

    Time frame: 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 outcomes

  1. Change in Weight

    Time frame: Baseline and Week 8

    Change in Weight as measured by digital scales

  2. Change in Body Mass Index (BMI)

    Time frame: Baseline and Week 8

    Change in BMI as assessed by digital scale for weight and stadiometer for height

  3. Change in Musculoskeletal Health Questionnaire (MSK-HQ)

    Time frame: 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.

  4. Change in Visual Analogue Scale (VAS) Muscle Pain

    Time frame: 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.

  5. Change in Visual Analogue Scale (VAS) Pain

    Time frame: 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

  6. Change in Visual Analogue Scale (VAS) Fatigue

    Time frame: 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.

  7. Change in Visual Analogue Scale (VAS) Mobility

    Time frame: 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.

  8. Change in Visual Analogue Scale (VAS) Stiffness

    Time frame: 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.

  9. Change in Multidimensional Fatigue Inventory (MFI)

    Time frame: 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.

  10. Change in The Perceived Recovery Status Scale (PRSS)

    Time frame: 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).

  11. Change in Blood Pressure (BP)

    Time frame: Baseline and Week 8

    Change in BP as assessed by digital blood pressure monitor

  12. Change in Heart Rate (HR)

    Time frame: 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

  13. Change in Oxygen Saturation

    Time frame: Baseline and Week 8

    Change in Oxygen Saturation as measured by pulse oximeter

  14. Change in Cytokines

    Time frame: Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)

    Change in Cytokines as measured by blood test

  15. Change in Nuclear Factor KappaB (NF-kB)

    Time frame: 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

  16. Change in P-selectin

    Time frame: 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

  17. Change in E-selectin

    Time frame: 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

  18. Change in Lipoprotein-associated Phospholipase A2 (Lp-PLA2)

    Time frame: 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

  19. Change in Intercellular Cell Adhesion Molecule-1 (ICAM-1)

    Time frame: 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

  20. Change in Intercellular Cell Adhesion Molecule-2 (ICAM-2)

    Time frame: 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

  21. Change in Vascular Cell Adhesion Molecule-1 (VCAM-1)

    Time frame: 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

  22. Change in Platelet Endothelial Cell Adhesion Molecule-1 (PECAM-1)

    Time frame: 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

  23. Change in Erythrocyte Sedimentation Rate (ESR)

    Time frame: Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)

    Change in ESR as measured by blood test

  24. Change in Lactate Dehydrogenase (LDH)

    Time frame: Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)

    Change in LDH as measured by blood test

  25. Change in P38 Mitogen-activated Protein Kinases (P38)

    Time frame: Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)

    Change in P38 as measured by blood test

  26. Change in Electrolytes and Liver Function Tests (E/LFT)

    Time frame: 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

  27. Change in Lactic acid

    Time frame: 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

  28. Change in C-reactive protein (CRP)

    Time frame: 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

  29. Change in myoglobin

    Time frame: 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

  30. Change in 1 Repetition Max (1-RM)

    Time frame: 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

  31. Change in Number of Repetitions to Fatigue

    Time frame: 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

  32. Change in Hand Grip Strength

    Time frame: 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

  33. Change in BORG Perception of intensity (RPE)

    Time frame: 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.

  34. Change in Adverse Events

    Time frame: 8 week period from enrolment to participant conclusion

    Change in Adverse Events self-reported by participants

  35. Change in Gastrointestinal Tolerance

    Time frame: 1 week after starting product

    Change in Gastrointestinal Tolerance as measured by Gastrointestinal Tolerance (GIT) Questionnaire

  36. Change in diet

    Time frame: Baseline and Week 8

    Change in diet as assessed by 3 day Diet Recall

Sponsors and collaborators

Lead sponsor

RDC Clinical Pty Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 31, 2024
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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