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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-27

Study Completion Date

2025-12-31

Brief Summary

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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 over 45 years old over 10 weeks with 8 weeks supplementation.

This is PART B of the study.

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Detailed Description

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Conditions

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Chronic Inflammation Mobility Muscle Pain Joint Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Maolactin

2 capsules containing a total of 500 mg/day active proteins taken once daily before the morning meal

Group Type EXPERIMENTAL

Maolactin

Intervention Type DRUG

Once daily dose of 2 capsules containing a total of 500mg/day Maolactin

Maltodextrin

2 capsules containing maltodextrin (0mg/day active proteins) taken once daily before the morning meal

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DRUG

Once daily dose of 2 capsules of Maltodextrin containing a total of 0mg/day Maolactin

Interventions

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Maolactin

Once daily dose of 2 capsules containing a total of 500mg/day Maolactin

Intervention Type DRUG

Maltodextrin

Once daily dose of 2 capsules of Maltodextrin containing a total of 0mg/day Maolactin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults 45 years and older
* 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

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes