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

NCT06444763 | Completed Phase 3

• 1 other identifier: MAOJOI(B)
• Study Type: interventional
• Target: 97
• 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 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.

Conditions

Chronic Inflammation; Mobility; Muscle Pain; Joint Pain

Outcome Measures

Primary Outcomes (1)

• Change in Inflammatory status

  Change in Inflammatory status as assessed by C-reactive protein (CRP) via blood test

  Baseline and Week 8

Secondary Outcomes (40)

• 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, Week 4 and Week 8

• Change in Visual Analogue Scale (VAS) Muscle Pain

  Baseline, Week 4 and Week 8

• Change in Visual Analogue Scale (VAS) Pain

  Baseline, Week 4 and Week 8

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

You may qualify if:

• 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

You may not qualify if:

• 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.
• An unstable intake is any dose that has changed by more than 10% of the previous dose in the past 4-weeks

Sponsors & Collaborators

• RDC Clinical Pty Ltd: lead

Study Sites (1)

RDC Clinical Pty Ltd

Brisbane, Queensland, 4006, Australia

Location

MeSH Terms

Conditions

Myalgia; Arthralgia

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; Joint Diseases

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: June 6, 2024
• Study Start: February 27, 2025
• Primary Completion: February 16, 2026
• Study Completion: February 16, 2026
• Last Updated: March 6, 2026

Record last verified: 2025-07

Locations

AU (1)