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

Last updated: October 14, 2024
Sponsor: RDC Clinical Pty Ltd
Overall Status: Active - Recruiting

Phase

3

Condition

Sarcopenia

Polymyositis (Inflammatory Muscle Disease)

Muscle Pain

Treatment

Maltodextrin

Maolactin

Clinical Study ID

NCT06436781
MAOJOI(A)
  • Ages 18-65
  • 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 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.

Eligibility Criteria

Inclusion

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 exercisesessions per week)

  • 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:

  • Undertaking high intensity exercise training and or undertaking more than 3 days ofresistance training per week.

  • 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: 40
Treatment Group(s): 2
Primary Treatment: Maltodextrin
Phase: 3
Study Start date:
September 12, 2024
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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