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

Launched by RDC CLINICAL PTY LTD · Jun 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a supplement called Maolactin FMR on how well people recover after exercise and on reducing inflammation and discomfort in muscles and joints. The study is designed for healthy adults aged 45 to 65 who have been experiencing pain or discomfort in their joints and muscles for at least three months. To participate, individuals must have a specific level of inflammation in their blood and a body mass index (BMI) between 25.0 and 35.0. Importantly, participants should not have serious or unstable medical conditions, be pregnant or nursing, or be involved in other clinical trials during this study.

Participants in this trial will be randomly assigned to either receive the Maolactin FMR supplement or a placebo (a pill that looks like the real thing but has no active ingredients) for 12 weeks. They will be monitored over a total of 14 weeks to assess any changes in their recovery from exercise, inflammation levels, and muscle and joint comfort. It's important for participants to maintain their usual diet and exercise routine throughout the study. This trial is currently recruiting, and it aims to find out if this supplement can help improve the quality of life for those dealing with chronic pain and inflammation.

Gender

ALL

Eligibility 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

Trial Officials