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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06444763
Other study ID # MAOJOI(B)
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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