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

Joint Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06444763
• Other study ID #: MAOJOI(B)
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 31, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: May 2024
• Source: RDC Clinical Pty Ltd
• Contact: Amanda Rao, PhD
• Phone: +61 414 488 559
• Email: amanda[@]rdcglobal.com.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Chronic Inflammation
• Inflammation
• Joint Pain
• Mobility
• Muscle Pain
• Myalgia

Intervention

Drug:
• Maolactin
Once daily dose of 2 capsules containing a total of 500mg/day Maolactin
• Maltodextrin
Once daily dose of 2 capsules of Maltodextrin containing a total of 0mg/day Maolactin

Locations

Country	Name	City	State
Australia	RDC Clinical Pty Ltd	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
RDC Clinical Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Inflammatory status	Change in Inflammatory status as assessed by C-reactive protein (CRP) via blood test	Baseline and Week 12
Secondary	Change in Weight	Change in Weight as measured by digital scales	Baseline and Week 12
Secondary	Change in Body Mass Index (BMI)	Change in BMI as assessed by digital scale for weight and stadiometer for height	Baseline and Week 12
Secondary	Change in Musculoskeletal Health Questionnaire (MSK-HQ)	Change in MSK-HQ as self-reported by participants. Scored on a range of 0-56, with a higher score indicating health status.	Baseline, Week 6 and Week 12
Secondary	Change in Visual Analogue Scale (VAS) Muscle Pain	Change in VAS Muscle Pain as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of muscle pain.	Baseline, Week 6 and Week 12
Secondary	Change in Visual Analogue Scale (VAS) Pain	Change in VAS Pain as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of pain	Baseline, Week 6 and Week 12
Secondary	Change in Visual Analogue Scale (VAS) Fatigue	Change in VAS Fatigue as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of fatigue.	Baseline, Week 6 and Week 12
Secondary	Change in Visual Analogue Scale (VAS) Mobility	Change in VAS Mobility as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of mobility.	Baseline, Week 6 and Week 12
Secondary	Change in Visual Analogue Scale (VAS) Stiffness	Change in VAS Stiffness as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of stiffness.	Baseline, Week 6 and Week 12
Secondary	Change in Multidimensional Fatigue Inventory (MFI)	Change in MFI as self-reported by participants. Comprises 20 questions rated on a 5 point scale. with a higher score indicating a higher level of fatigue.	Baseline, Week 6 and Week 12
Secondary	Change in Blood Pressure (BP)	Change in BP as assessed by digital blood pressure monitor	Baseline and Week 12
Secondary	Change in Heart Rate (HR)	Change in HR as assessed by digital heart rate monitor	Baseline and Week 12
Secondary	Change in Oxygen Saturation	Change in Oxygen Saturation as measured by pulse oximeter	Baseline and Week 12
Secondary	Change in Cytokines	Change in Cytokines as measured by blood test	Baseline and Week 12
Secondary	Change in Monocyte Chemotactic Protein-1 (MCP-1)	Change in MCP-1 as measured by blood test	Baseline and Week 12
Secondary	Change in Nuclear Factor KappaB (NF-kB)	Change in NF-kB as measured by blood test	Baseline and Week 12
Secondary	Change in P-selectin	Change in P-selectin as measured by blood test	Baseline and Week 12
Secondary	Change in E-selectin	Change in E-selectin as measured by blood test	Baseline and Week 12
Secondary	Change in Matrix Metalloproteinase-3 (MMP3)	Change in MMP3 as measured by blood test	Baseline and Week 12
Secondary	Change in Cartilage Oligomeric Matrix Protein (COMP/thrombospondin-5)	Change in COMP as measured by blood test	Baseline and Week 12
Secondary	Change in Type II procollagen (CPII)	Change in CPII as measured by blood test	Baseline and Week 12
Secondary	Change in Type II collagen (C2C)	Change in C2C as measured by blood test	Baseline and Week 12
Secondary	Change in Creatine Kinase (CK)	Change in CK as measured by blood test	Baseline and Week 12
Secondary	Change in Myoglobin	Change in Myoglobin as measured by blood test	Baseline and Week 12
Secondary	Change in Full Blood Count (FBC)	Change in FBC as measured by blood test	Baseline and Week 12
Secondary	Change in Platelet agglomeration	Change in Platelet agglomeration as measured by blood test	Baseline and Week 12
Secondary	Change in Lipoprotein-associated phospholipase A2 (Lp-PLA2)	Change in Lp-PLA2 as measured by blood test	Baseline and Week 12
Secondary	Change in Intercellular Cell Adhesion Molecule-1 (ICAM-1)	Change in ICAM-1 as measured by blood test	Baseline and Week 12
Secondary	Change in Intercellular Cell Adhesion Molecule-2 (ICAM-2)	Change in ICAM-2 as measured by blood test	Baseline and Week 12
Secondary	Change in Vascular Cell Adhesion Molecule-1 (VCAM-1)	Change in VCAM-1 as measured by blood test	Baseline and Week 12
Secondary	Change in Vascular Cell Adhesion Molecule-2 (VCAM-2)	Change in VCAM-2 as measured by blood test	Baseline and Week 12
Secondary	Change in Platelet Endothelial Cell Adhesion Molecule-1 (PECAM-1)	Change in PECAM-1 as measured by blood test	Baseline and Week 12
Secondary	Change in Erythrocyte Sedimentation Rate (ESR)	Change in ESR as measured by blood test	Baseline and Week 12
Secondary	Change in Lactate Dehydrogenase (LDH)	Change in LDH as measured by blood test	Baseline and Week 12
Secondary	Change in P38 Mitogen-activated Protein Kinases (P38)	Change in P38 as measured by blood test	Baseline and Week 12
Secondary	Change in Electrolytes and Liver Function Tests (E/LFT)	Change in E/LFT as measured by blood test	Baseline and Week 12
Secondary	Change in 2 minute walk test	Change in 2 minute walk test as measured by exercise testing	Baseline and Week 12
Secondary	Change in sit-to-stand test	Change in sit-to-stand test as measured by exercise testing	Baseline and Week 12
Secondary	Change in Hand Grip Strength	Change in Hand Grip Strength as measured by dynamometer	Baseline and Week 12
Secondary	Change in Adverse Events	Change in Adverse Events self-reported by participants	12 week period from enrolment to participant conclusion
Secondary	Change in Gastrointestinal Tolerance	Change in Gastrointestinal Tolerance as measured by Gastrointestinal Tolerance (GIT) Questionnaire	1 week after starting product and Week 12