Effect of Maolactin FMR on exercise recovery and muscle comfort
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 study tests whether taking Maolactin FMR can help healthy adults aged 45-65 feel less muscle and joint pain and recover better after exercise.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 45 Years to 65 Years |
| Sex | All |
| Sponsor | RDC Clinical Pty Ltd Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Brisbane, Queensland) |
| Trial ID | NCT06444763 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of Maolactin FMR supplementation on chronic inflammation, mobility, and muscle and joint pain in healthy adults aged 45-65. It is a double-blind, randomized, placebo-controlled study conducted over 14 weeks, with 12 weeks of supplementation. Participants will be monitored for changes in pain and inflammation levels, ensuring they maintain their usual diet and exercise routines throughout the study.
Who should consider this trial
Good fit: Ideal candidates are generally healthy adults aged 45-65 with a BMI between 25.0 and 35.0 kg/m2 who experience muscle or joint pain for at least three months.
Not a fit: Patients with serious or unstable illnesses, recent malignancies, or those on specific anticoagulant medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new approach to alleviating chronic inflammation and muscle discomfort in middle-aged adults.
How similar studies have performed: While this specific approach may be novel, similar studies on dietary supplements for inflammation and pain management have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 study period * Agree to not participate in another clinical trial while enrolled in this trial Exclusion Criteria: * 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
Where this trial is running
Brisbane, Queensland
- RDC Clinical Pty Ltd — Brisbane, Queensland, Australia (Recruiting)
Study contacts
- Principal investigator: David Briskey, PhD — RDC Clinical Pty Ltd
- Study coordinator: Amanda Rao, PhD
- Email: amanda@rdcglobal.com.au
- Phone: +61 414 488 559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.