Effect of Maolactin™ FMR on Exercise Recovery, Inflammation, and Muscle Comfort in an Otherwise Healthy Population
Launched by RDC CLINICAL PTY LTD · May 24, 2024
Trial Information
Current as of February 08, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of a supplement called Maolactin FMR on how well people recover after exercise, and how it affects inflammation, muscle fatigue, and pain. The trial will involve healthy adults aged 18 to 65 who are generally active and participate in low to moderate exercise. Participants will take either the supplement or a placebo (a non-active pill that looks the same) for 8 weeks, and the entire study will last for 10 weeks.
To be eligible, participants need to be healthy, have a body mass index (BMI) between 19.0 and 29.9, and agree not to change their diet or exercise routine during the study. However, those who do high-intensity workouts, have serious health issues, or are taking certain medications may not qualify. Throughout the study, participants will be monitored to see how the supplement affects their recovery and muscle comfort after exercise. It’s important to note that this trial is currently recruiting participants, so interested individuals should consider reaching out for more information.
Gender
ALL
Eligibility criteria
- 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 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
- Exclusion Criteria:
- • 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
- • 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
Trial Officials
David Briskey, PhD
Principal Investigator
RDC Clinical Pty Ltd
About Rdc Clinical Pty Ltd
RDC Clinical Pty Ltd is a leading clinical research organization dedicated to advancing medical science through innovative trial design and execution. With a strong focus on delivering high-quality data and patient-centered research solutions, RDC Clinical partners with pharmaceutical, biotechnology, and medical device companies to facilitate the development of new therapies. Their team of experienced professionals is committed to maintaining the highest ethical standards and regulatory compliance, ensuring the integrity of clinical trials while optimizing operational efficiencies. RDC Clinical's expertise spans various therapeutic areas, making them a trusted partner in the clinical development landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Brisbane, Queensland, Australia
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0