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

RDC Clinical

Status and phase: Enrolling; Phase 3

Conditions: Mobility; Chronic Inflammation; Joint Pain; Muscle Pain

Treatments: Drug: Maolactin; Drug: Maltodextrin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06444763

MAOJOI(B)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Maolactin

Experimental group

Description:

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

Treatment:

Drug: Maolactin

Maltodextrin

Placebo Comparator group

Description:

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

Treatment:

Drug: Maltodextrin