Effect of Maolactin™ FMR on Exercise Recovery, Inflammation and Muscle Comfort in an Otherwise Healthy Population
- Conditions
- MobilityJoint PainChronic InflammationMuscle Pain
- Interventions
- Drug: Maolactin
- Registration Number
- NCT06444763
- Lead Sponsor
- RDC Clinical Pty Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
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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
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Unstable intake of any medication or supplement(3)
-
Acute injuries on reporting area
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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
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Receiving medications known to affect inflammation such as steroids
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Active smokers, nicotine use or drug (prescription or illegal substances) abuse
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Chronic past and/or current alcohol use (>21 alcoholic drinks per week)
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Pregnant or lactating women
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Allergic to any of the ingredients in active or placebo formula
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Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month
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Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
- 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.
- An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity.
- An unstable intake is any dose that has changed by more than 10% of the previous dose in the past 4-weeks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Maolactin Maolactin 2 capsules containing a total of 500 mg/day active proteins taken once daily before the morning meal Maltodextrin Maltodextrin 2 capsules containing maltodextrin (0mg/day active proteins) taken once daily before the morning meal
- Primary Outcome Measures
Name Time Method Change in Inflammatory status Baseline and Week 12 Change in Inflammatory status as assessed by C-reactive protein (CRP) via blood test
- Secondary Outcome Measures
Name Time Method Change in Blood Pressure (BP) Baseline and Week 12 Change in BP as assessed by digital blood pressure monitor
Change in Heart Rate (HR) Baseline and Week 12 Change in HR as assessed by digital heart rate monitor
Change in Weight Baseline and Week 12 Change in Weight as measured by digital scales
Change in Visual Analogue Scale (VAS) Muscle Pain Baseline, Week 6 and Week 12 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.
Change in Body Mass Index (BMI) Baseline and Week 12 Change in BMI as assessed by digital scale for weight and stadiometer for height
Change in Visual Analogue Scale (VAS) Pain Baseline, Week 6 and Week 12 Change in VAS Pain as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of pain
Change in Creatine Kinase (CK) Baseline and Week 12 Change in CK as measured by blood test
Change in Erythrocyte Sedimentation Rate (ESR) Baseline and Week 12 Change in ESR as measured by blood test
Change in sit-to-stand test Baseline and Week 12 Change in sit-to-stand test as measured by exercise testing
Change in Visual Analogue Scale (VAS) Mobility Baseline, Week 6 and Week 12 Change in VAS Mobility as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of mobility.
Change in Nuclear Factor KappaB (NF-kB) Baseline and Week 12 Change in NF-kB as measured by blood test
Change in Matrix Metalloproteinase-3 (MMP3) Baseline and Week 12 Change in MMP3 as measured by blood test
Change in Cartilage Oligomeric Matrix Protein (COMP/thrombospondin-5) Baseline and Week 12 Change in COMP as measured by blood test
Change in Type II procollagen (CPII) Baseline and Week 12 Change in CPII as measured by blood test
Change in Type II collagen (C2C) Baseline and Week 12 Change in C2C as measured by blood test
Change in Lactate Dehydrogenase (LDH) Baseline and Week 12 Change in LDH as measured by blood test
Change in Hand Grip Strength Baseline and Week 12 Change in Hand Grip Strength as measured by dynamometer
Change in Visual Analogue Scale (VAS) Fatigue Baseline, Week 6 and Week 12 Change in VAS Fatigue as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of fatigue.
Change in Visual Analogue Scale (VAS) Stiffness Baseline, Week 6 and Week 12 Change in VAS Stiffness as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of stiffness.
Change in Oxygen Saturation Baseline and Week 12 Change in Oxygen Saturation as measured by pulse oximeter
Change in Monocyte Chemotactic Protein-1 (MCP-1) Baseline and Week 12 Change in MCP-1 as measured by blood test
Change in P-selectin Baseline and Week 12 Change in P-selectin as measured by blood test
Change in E-selectin Baseline and Week 12 Change in E-selectin as measured by blood test
Change in Myoglobin Baseline and Week 12 Change in Myoglobin as measured by blood test
Change in Lipoprotein-associated phospholipase A2 (Lp-PLA2) Baseline and Week 12 Change in Lp-PLA2 as measured by blood test
Change in Intercellular Cell Adhesion Molecule-1 (ICAM-1) Baseline and Week 12 Change in ICAM-1 as measured by blood test
Change in Intercellular Cell Adhesion Molecule-2 (ICAM-2) Baseline and Week 12 Change in ICAM-2 as measured by blood test
Change in 2 minute walk test Baseline and Week 12 Change in 2 minute walk test as measured by exercise testing
Change in Adverse Events 12 week period from enrolment to participant conclusion Change in Adverse Events self-reported by participants
Change in Musculoskeletal Health Questionnaire (MSK-HQ) Baseline, Week 6 and Week 12 Change in MSK-HQ as self-reported by participants. Scored on a range of 0-56, with a higher score indicating health status.
Change in Multidimensional Fatigue Inventory (MFI) Baseline, Week 6 and Week 12 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.
Change in Full Blood Count (FBC) Baseline and Week 12 Change in FBC as measured by blood test
Change in Platelet agglomeration Baseline and Week 12 Change in Platelet agglomeration as measured by blood test
Change in Vascular Cell Adhesion Molecule-1 (VCAM-1) Baseline and Week 12 Change in VCAM-1 as measured by blood test
Change in Platelet Endothelial Cell Adhesion Molecule-1 (PECAM-1) Baseline and Week 12 Change in PECAM-1 as measured by blood test
Change in P38 Mitogen-activated Protein Kinases (P38) Baseline and Week 12 Change in P38 as measured by blood test
Change in Cytokines Baseline and Week 12 Change in Cytokines as measured by blood test
Change in Vascular Cell Adhesion Molecule-2 (VCAM-2) Baseline and Week 12 Change in VCAM-2 as measured by blood test
Change in Electrolytes and Liver Function Tests (E/LFT) Baseline and Week 12 Change in E/LFT as measured by blood test
Change in Gastrointestinal Tolerance 1 week after starting product and Week 12 Change in Gastrointestinal Tolerance as measured by Gastrointestinal Tolerance (GIT) Questionnaire
Trial Locations
- Locations (1)
RDC Clinical Pty Ltd
🇦🇺Brisbane, Queensland, Australia