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

Last updated: March 6, 2025
Sponsor: RDC Clinical Pty Ltd
Overall Status: Active - Recruiting

Phase

3

Condition

Inflammation

Muscle Pain

Joint Injuries

Treatment

Maltodextrin

Maolactin

Clinical Study ID

NCT06444763
MAOJOI(B)
  • Ages 45-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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 45-65 years old over 14 weeks with 12 weeks supplementation.

This is PART B of the study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults 45-65 years old

  • 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 studyperiod

  • Agree to not participate in another clinical trial while enrolled in this trial

Exclusion

Exclusion Criteria:

  • Serious illness(1) e.g., mood disorders such as depression, anxiety or bipolardisorder, neurological disorders such as MS, kidney disease, liver disease or heartconditions

  • 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 radiotherapytreatment for malignancy within the previous 2 years

  • Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or otheranticoagulation 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 haveparticipated in any other clinical trial during the past 1 month

  • Any condition which in the opinion of the investigator makes the participantunsuitable for inclusion

  1. A serious illness is a condition that carries a risk of mortality, negativelyimpacts quality of life and daily function and/or is burdensome in symptomsand/or treatments.

  2. An unstable illness is any illness that is currently not being treated with astable dose of medication or is fluctuating in severity.

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

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Maltodextrin
Phase: 3
Study Start date:
February 27, 2025
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • RDC Clinical Pty Ltd

    Brisbane, Queensland 4006
    Australia

    Active - Recruiting

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