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

NCT06436781 | Completed Phase 3

• 1 other identifier: MAOJOI(A)
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Exercise Inflammation; Exercise Recovery; Muscle Fatigue; Muscle Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (36)

• Change in Weight

  Baseline and Week 8

• Change in Body Mass Index (BMI)

  Baseline and Week 8

• 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 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 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))

Study Arms (2)

Maolactin

EXPERIMENTAL

2 capsules containing a total of 500 mg/day active proteins taken once daily before the morning meal

Drug: Maolactin

Maltodextrin

PLACEBO COMPARATOR

2 capsules containing maltodextrin (0mg/day active proteins) taken once daily before the morning meal

Drug: Maltodextrin

Interventions

Maolactin DRUG

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

Maolactin

Maltodextrin DRUG

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

Maltodextrin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• RDC Clinical Pty Ltd: lead

Study Sites (1)

RDC Clinical Pty Ltd

Brisbane, Queensland, 4006, Australia

Location

MeSH Terms

Conditions

Myalgia

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Briskey, PhD

  RDC Clinical Pty Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 31, 2024
• Study Start: September 12, 2024
• Primary Completion: May 23, 2025
• Study Completion: May 23, 2025
• Last Updated: June 25, 2025

Record last verified: 2024-10

Locations

AU (1)