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

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.

Study Overview

• Status: Completed
• Conditions: Muscle Pain; Muscle Fatigue; Exercise Recovery; Post Exercise Inflammation
• Intervention / Treatment: Drug: Maolactin; Drug: Maltodextrin

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4006
      • RDC Clinical Pty Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Maolactin; 2 capsules containing a total of 500 mg/day active proteins taken once daily before the morning meal	Drug: Maolactin; Once daily dose of 2 capsules containing a total of 500mg/day Maolactin
Placebo Comparator: Maltodextrin; 2 capsules containing maltodextrin (0mg/day active proteins) taken once daily before the morning meal	Drug: Maltodextrin; Once daily dose of 2 capsules of Maltodextrin containing a total of 0mg/day Maolactin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: RDC Clinical Pty Ltd
• Investigators: Principal Investigator: David Briskey, PhD, RDC Clinical Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2024
• Primary Completion (Actual): May 23, 2025
• Study Completion (Actual): May 23, 2025

Study Registration Dates

• First Submitted: May 24, 2024
• First Submitted That Met QC Criteria: May 24, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 20, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Pathologic Processes; Neuromuscular Diseases; Musculoskeletal Pain; Inflammation; Myalgia
• Other Study ID Numbers: MAOJOI(A)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No