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OpenTrials
Completed

NCT Number: NCT06444763

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 chronic inflammation, mobility and muscle and joint pain in an otherwise healthy population of adults over 45 years old over 10 weeks with 8 weeks supplementation.

This is PART B of the study.

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Key information

Conditions

Chronic Inflammation Arthralgia Joint Diseases Joint Pain Mobility 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

45 year and older

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 45 years and older
  • Generally healthy
  • BMI 25.0 - 35.0 kg/m2
  • C-reactive protein (CRP) equal to or greater than 2.0 mg/L
  • Feel pain or discomfort in joints/muscle for at least 3 months
  • Able to provide informed consent
  • 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

  • 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 Inflammatory status

    Time frame: Baseline and Week 8

    Change in Inflammatory status as assessed by C-reactive protein (CRP) 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, Week 4 and Week 8

    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, Week 4 and Week 8

    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, Week 4 and Week 8

    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, Week 4 and Week 8

    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, Week 4 and Week 8

    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, Week 4 and Week 8

    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, Week 4 and Week 8

    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 Blood Pressure (BP)

    Time frame: Baseline and Week 8

    Change in BP as assessed by digital blood pressure monitor

  11. Change in Heart Rate (HR)

    Time frame: Baseline and Week 8

    Change in HR as assessed by digital heart rate monitor

  12. Change in Oxygen Saturation

    Time frame: Baseline and Week 8

    Change in Oxygen Saturation as measured by pulse oximeter

  13. Change in Cytokines

    Time frame: Baseline and Week 8

    Change in Cytokines as measured by blood test

  14. Change in Monocyte Chemotactic Protein-1 (MCP-1)

    Time frame: Baseline and Week 8

    Change in MCP-1 as measured by blood test

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

    Time frame: Baseline and Week 8

    Change in NF-kB as measured by blood test

  16. Change in P-selectin

    Time frame: Baseline and Week 8

    Change in P-selectin as measured by blood test

  17. Change in E-selectin

    Time frame: Baseline and Week 8

    Change in E-selectin as measured by blood test

  18. Change in Matrix Metalloproteinase-3 (MMP3)

    Time frame: Baseline and Week 8

    Change in MMP3 as measured by blood test

  19. Change in Cartilage Oligomeric Matrix Protein (COMP/thrombospondin-5)

    Time frame: Baseline and Week 8

    Change in COMP as measured by blood test

  20. Change in Type II procollagen (CPII)

    Time frame: Baseline and Week 8

    Change in CPII as measured by blood test

  21. Change in Type II collagen (C2C)

    Time frame: Baseline and Week 8

    Change in C2C as measured by blood test

  22. Change in Creatine Kinase (CK)

    Time frame: Baseline and Week 8

    Change in CK as measured by blood test

  23. Change in Myoglobin

    Time frame: Baseline and Week 8

    Change in Myoglobin as measured by blood test

  24. Change in Full Blood Count (FBC)

    Time frame: Baseline and Week 8

    Change in FBC as measured by blood test

  25. Change in Platelet agglomeration

    Time frame: Baseline and Week 8

    Change in Platelet agglomeration as measured by blood test

  26. Change in Lipoprotein-associated phospholipase A2 (Lp-PLA2)

    Time frame: Baseline and Week 8

    Change in Lp-PLA2 as measured by blood test

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

    Time frame: Baseline and Week 8

    Change in ICAM-1 as measured by blood test

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

    Time frame: Baseline and Week 8

    Change in ICAM-2 as measured by blood test

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

    Time frame: Baseline and Week 8

    Change in VCAM-1 as measured by blood test

  30. Change in Vascular Cell Adhesion Molecule-2 (VCAM-2)

    Time frame: Baseline and Week 8

    Change in VCAM-2 as measured by blood test

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

    Time frame: Baseline and Week 8

    Change in PECAM-1 as measured by blood test

  32. Change in Erythrocyte Sedimentation Rate (ESR)

    Time frame: Baseline and Week 8

    Change in ESR as measured by blood test

  33. Change in Lactate Dehydrogenase (LDH)

    Time frame: Baseline and Week 8

    Change in LDH as measured by blood test

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

    Time frame: Baseline and Week 8

    Change in P38 as measured by blood test

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

    Time frame: Baseline and Week 8

    Change in E/LFT as measured by blood test

  36. Change in 2 minute walk test

    Time frame: Baseline and Week 8

    Change in 2 minute walk test as measured by exercise testing

  37. Change in sit-to-stand test

    Time frame: Baseline and Week 8

    Change in sit-to-stand test as measured by exercise testing

  38. Change in Hand Grip Strength

    Time frame: Baseline and Week 8

    Change in Hand Grip Strength as measured by dynamometer

  39. Change in Adverse Events

    Time frame: Baseline to week 8

    Change in Adverse Events self-reported by participants

  40. Change in Gastrointestinal Tolerance

    Time frame: 1 week after starting product and Week 8

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

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
2025
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2024
Registry last updated
Mar 6, 2026

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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