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

RDC Clinical Pty Ltd97 enrolled

Overview

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 over 45 years old over 10 weeks with 8 weeks supplementation. This is PART B of the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Chronic Inflammation Mobility Muscle Pain Joint Pain

Interventions

MaolactinDRUG

Once daily dose of 2 capsules containing a total of 500mg/day Maolactin

MaltodextrinDRUG

Once daily dose of 2 capsules of Maltodextrin containing a total of 0mg/day Maolactin

Eligibility

Sex: ALLMin age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Adults 45 years and older * 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

Locations (1)

RDC Clinical Pty Ltd

Brisbane, Queensland, Australia

Outcomes

Primary Outcomes

Change in Inflammatory status

Change in Inflammatory status as assessed by C-reactive protein (CRP) via blood test

Time frame: Baseline and Week 8

Secondary Outcomes

Change in Weight

Change in Weight as measured by digital scales

Time frame: Baseline and Week 8

Change in Body Mass Index (BMI)

Change in BMI as assessed by digital scale for weight and stadiometer for height

Time frame: Baseline and Week 8

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.

Time frame: Baseline, Week 4 and Week 8

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.

Time frame: Baseline, Week 4 and Week 8

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

Time frame: Baseline, Week 4 and Week 8

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.

Time frame: Baseline, Week 4 and Week 8

Data from ClinicalTrials.gov

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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.

Time frame: Baseline, Week 4 and Week 8

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.

Time frame: Baseline, Week 4 and Week 8

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.

Time frame: Baseline, Week 4 and Week 8

Change in Blood Pressure (BP)

Change in BP as assessed by digital blood pressure monitor

Time frame: Baseline and Week 8

Change in Heart Rate (HR)

Change in HR as assessed by digital heart rate monitor

Time frame: Baseline and Week 8

Change in Oxygen Saturation

Change in Oxygen Saturation as measured by pulse oximeter

Time frame: Baseline and Week 8

Change in Cytokines

Change in Cytokines as measured by blood test

Time frame: Baseline and Week 8

Change in Monocyte Chemotactic Protein-1 (MCP-1)

Change in MCP-1 as measured by blood test

Time frame: Baseline and Week 8

Change in Nuclear Factor KappaB (NF-kB)

Change in NF-kB as measured by blood test

Time frame: Baseline and Week 8

Change in P-selectin

Change in P-selectin as measured by blood test

Time frame: Baseline and Week 8

Change in E-selectin

Change in E-selectin as measured by blood test

Time frame: Baseline and Week 8

Change in Matrix Metalloproteinase-3 (MMP3)

Change in MMP3 as measured by blood test

Time frame: Baseline and Week 8

Change in Cartilage Oligomeric Matrix Protein (COMP/thrombospondin-5)

Change in COMP as measured by blood test

Time frame: Baseline and Week 8

Change in Type II procollagen (CPII)

Change in CPII as measured by blood test

Time frame: Baseline and Week 8

Change in Type II collagen (C2C)

Change in C2C as measured by blood test

Time frame: Baseline and Week 8

Change in Creatine Kinase (CK)

Change in CK as measured by blood test

Time frame: Baseline and Week 8

Change in Myoglobin

Change in Myoglobin as measured by blood test

Time frame: Baseline and Week 8

Change in Full Blood Count (FBC)

Change in FBC as measured by blood test

Time frame: Baseline and Week 8

Change in Platelet agglomeration

Change in Platelet agglomeration as measured by blood test

Time frame: Baseline and Week 8

Change in Lipoprotein-associated phospholipase A2 (Lp-PLA2)

Change in Lp-PLA2 as measured by blood test

Time frame: Baseline and Week 8

Change in Intercellular Cell Adhesion Molecule-1 (ICAM-1)

Change in ICAM-1 as measured by blood test

Time frame: Baseline and Week 8

Change in Intercellular Cell Adhesion Molecule-2 (ICAM-2)

Change in ICAM-2 as measured by blood test

Time frame: Baseline and Week 8

Change in Vascular Cell Adhesion Molecule-1 (VCAM-1)

Change in VCAM-1 as measured by blood test

Time frame: Baseline and Week 8

Change in Vascular Cell Adhesion Molecule-2 (VCAM-2)

Change in VCAM-2 as measured by blood test

Time frame: Baseline and Week 8

Change in Platelet Endothelial Cell Adhesion Molecule-1 (PECAM-1)

Change in PECAM-1 as measured by blood test

Time frame: Baseline and Week 8

Change in Erythrocyte Sedimentation Rate (ESR)

Change in ESR as measured by blood test

Time frame: Baseline and Week 8

Change in Lactate Dehydrogenase (LDH)

Change in LDH as measured by blood test

Time frame: Baseline and Week 8

Change in P38 Mitogen-activated Protein Kinases (P38)

Change in P38 as measured by blood test

Time frame: Baseline and Week 8

Change in Electrolytes and Liver Function Tests (E/LFT)

Change in E/LFT as measured by blood test

Time frame: Baseline and Week 8

Change in 2 minute walk test

Change in 2 minute walk test as measured by exercise testing

Time frame: Baseline and Week 8

Change in sit-to-stand test

Change in sit-to-stand test as measured by exercise testing

Time frame: Baseline and Week 8

Change in Hand Grip Strength

Change in Hand Grip Strength as measured by dynamometer

Time frame: Baseline and Week 8

Change in Adverse Events

Change in Adverse Events self-reported by participants

Time frame: Baseline to week 8

Change in Gastrointestinal Tolerance

Change in Gastrointestinal Tolerance as measured by Gastrointestinal Tolerance (GIT) Questionnaire

Time frame: 1 week after starting product and Week 8