Clinical trial NCT06444763: Effect of Maolactin™ FMR on Exercise Recovery, Inflammation and Muscle Comfort in an Otherwise Healthy Population
Official title: Effect of Maolactin™ FMR Supplementation on Exercise Recovery, Inflammation, and Muscle Comfort in an Otherwise Healthy Population: A Double-blind Randomized Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Chronic Inflammation
Mobility
Muscle Pain
Joint Pain
Lead sponsor: RDC Clinical Pty Ltd
Sponsor class: INDUSTRY
First posted: 2024-06-06
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Change in Inflammatory status
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change in Weight
timeFrame: Baseline and Week 12
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline and Week 12
measure: Change in Musculoskeletal Health Questionnaire (MSK-HQ)
timeFrame: Baseline, Week 6 and Week 12
measure: Change in Visual Analogue Scale (VAS) Muscle Pain
timeFrame: Baseline, Week 6 and Week 12
measure: Change in Visual Analogue Scale (VAS) Pain
timeFrame: Baseline, Week 6 and Week 12
measure: Change in Visual Analogue Scale (VAS) Fatigue
timeFrame: Baseline, Week 6 and Week 12
measure: Change in Visual Analogue Scale (VAS) Mobility
timeFrame: Baseline, Week 6 and Week 12
measure: Change in Visual Analogue Scale (VAS) Stiffness
timeFrame: Baseline, Week 6 and Week 12
measure: Change in Multidimensional Fatigue Inventory (MFI)
timeFrame: Baseline, Week 6 and Week 12
measure: Change in Blood Pressure (BP)
timeFrame: Baseline and Week 12
measure: Change in Heart Rate (HR)
timeFrame: Baseline and Week 12
measure: Change in Oxygen Saturation
timeFrame: Baseline and Week 12
measure: Change in Cytokines
timeFrame: Baseline and Week 12
measure: Change in Monocyte Chemotactic Protein-1 (MCP-1)
timeFrame: Baseline and Week 12
measure: Change in Nuclear Factor KappaB (NF-kB)
timeFrame: Baseline and Week 12
measure: Change in P-selectin
timeFrame: Baseline and Week 12
measure: Change in E-selectin
timeFrame: Baseline and Week 12
measure: Change in Matrix Metalloproteinase-3 (MMP3)
timeFrame: Baseline and Week 12
measure: Change in Cartilage Oligomeric Matrix Protein (COMP/thrombospondin-5)
timeFrame: Baseline and Week 12
measure: Change in Type II procollagen (CPII)
timeFrame: Baseline and Week 12
measure: Change in Type II collagen (C2C)
timeFrame: Baseline and Week 12
measure: Change in Creatine Kinase (CK)
timeFrame: Baseline and Week 12
measure: Change in Myoglobin
timeFrame: Baseline and Week 12
measure: Change in Full Blood Count (FBC)
timeFrame: Baseline and Week 12
measure: Change in Platelet agglomeration
timeFrame: Baseline and Week 12
measure: Change in Lipoprotein-associated phospholipase A2 (Lp-PLA2)
timeFrame: Baseline and Week 12
measure: Change in Intercellular Cell Adhesion Molecule-1 (ICAM-1)
timeFrame: Baseline and Week 12
measure: Change in Intercellular Cell Adhesion Molecule-2 (ICAM-2)
timeFrame: Baseline and Week 12
measure: Change in Vascular Cell Adhesion Molecule-1 (VCAM-1)
timeFrame: Baseline and Week 12
measure: Change in Vascular Cell Adhesion Molecule-2 (VCAM-2)
timeFrame: Baseline and Week 12
measure: Change in Platelet Endothelial Cell Adhesion Molecule-1 (PECAM-1)
timeFrame: Baseline and Week 12
measure: Change in Erythrocyte Sedimentation Rate (ESR)
timeFrame: Baseline and Week 12
measure: Change in Lactate Dehydrogenase (LDH)
timeFrame: Baseline and Week 12
measure: Change in P38 Mitogen-activated Protein Kinases (P38)
timeFrame: Baseline and Week 12
measure: Change in Electrolytes and Liver Function Tests (E/LFT)
timeFrame: Baseline and Week 12
measure: Change in 2 minute walk test
timeFrame: Baseline and Week 12
measure: Change in sit-to-stand test
timeFrame: Baseline and Week 12
measure: Change in Hand Grip Strength
timeFrame: Baseline and Week 12
measure: Change in Adverse Events
timeFrame: 12 week period from enrolment to participant conclusion
measure: Change in Gastrointestinal Tolerance
timeFrame: 1 week after starting product and Week 12
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: RDC Clinical Pty Ltd
state: Queensland
Study officials:
affiliation: RDC Clinical Pty Ltd
name: David Briskey, PhD
role: PRINCIPAL_INVESTIGATOR
References: