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 45-65 years old over 14 weeks with 12 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 45-65 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 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