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
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.
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 |
Country | Name | City | State |
---|---|---|---|
Australia | RDC Clinical Pty Ltd | Brisbane | Queensland |
Lead Sponsor | Collaborator |
---|---|
RDC Clinical Pty Ltd |
Australia,
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 |
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