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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06444763
Registration number
NCT06444763
Ethics application status
Date submitted
24/05/2024
Date registered
6/06/2024
Date last updated
6/06/2024
Titles & IDs
Public title
Effect of Maolactin™ FMR on Exercise Recovery, Inflammation and Muscle Comfort in an Otherwise Healthy Population
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Scientific 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
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Secondary ID [1]
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MAOJOI(B)
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Inflammation
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Mobility
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Muscle Pain
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Joint Pain
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Maolactin
Treatment: Drugs - Maltodextrin
Experimental: Maolactin - 2 capsules containing a total of 500 mg/day active proteins taken once daily before the morning meal
Placebo comparator: Maltodextrin - 2 capsules containing maltodextrin (0mg/day active proteins) taken once daily before the morning meal
Treatment: Drugs: Maolactin
Once daily dose of 2 capsules containing a total of 500mg/day Maolactin
Treatment: Drugs: Maltodextrin
Once daily dose of 2 capsules of Maltodextrin containing a total of 0mg/day Maolactin
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Inflammatory status
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Assessment method [1]
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Change in Inflammatory status as assessed by C-reactive protein (CRP) via blood test
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Timepoint [1]
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Baseline and Week 12
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Secondary outcome [1]
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Change in Weight
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Assessment method [1]
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Change in Weight as measured by digital scales
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Timepoint [1]
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Baseline and Week 12
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Secondary outcome [2]
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Change in Body Mass Index (BMI)
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Assessment method [2]
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Change in BMI as assessed by digital scale for weight and stadiometer for height
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Timepoint [2]
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Baseline and Week 12
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Secondary outcome [3]
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Change in Musculoskeletal Health Questionnaire (MSK-HQ)
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Assessment method [3]
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Change in MSK-HQ as self-reported by participants. Scored on a range of 0-56, with a higher score indicating health status.
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Timepoint [3]
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Baseline, Week 6 and Week 12
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Secondary outcome [4]
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Change in Visual Analogue Scale (VAS) Muscle Pain
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline, Week 6 and Week 12
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Secondary outcome [5]
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Change in Visual Analogue Scale (VAS) Pain
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Assessment method [5]
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Change in VAS Pain as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of pain
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Timepoint [5]
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Baseline, Week 6 and Week 12
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Secondary outcome [6]
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Change in Visual Analogue Scale (VAS) Fatigue
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Assessment method [6]
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Change in VAS Fatigue as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of fatigue.
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Timepoint [6]
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Baseline, Week 6 and Week 12
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Secondary outcome [7]
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Change in Visual Analogue Scale (VAS) Mobility
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Assessment method [7]
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Change in VAS Mobility as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of mobility.
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Timepoint [7]
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Baseline, Week 6 and Week 12
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Secondary outcome [8]
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Change in Visual Analogue Scale (VAS) Stiffness
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Assessment method [8]
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Change in VAS Stiffness as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of stiffness.
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Timepoint [8]
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Baseline, Week 6 and Week 12
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Secondary outcome [9]
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Change in Multidimensional Fatigue Inventory (MFI)
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline, Week 6 and Week 12
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Secondary outcome [10]
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Change in Blood Pressure (BP)
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Assessment method [10]
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Change in BP as assessed by digital blood pressure monitor
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Timepoint [10]
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Baseline and Week 12
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Secondary outcome [11]
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Change in Heart Rate (HR)
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Assessment method [11]
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Change in HR as assessed by digital heart rate monitor
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Timepoint [11]
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Baseline and Week 12
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Secondary outcome [12]
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Change in Oxygen Saturation
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Assessment method [12]
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Change in Oxygen Saturation as measured by pulse oximeter
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Timepoint [12]
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Baseline and Week 12
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Secondary outcome [13]
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Change in Cytokines
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Assessment method [13]
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Change in Cytokines as measured by blood test
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Timepoint [13]
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Baseline and Week 12
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Secondary outcome [14]
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Change in Monocyte Chemotactic Protein-1 (MCP-1)
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Assessment method [14]
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Change in MCP-1 as measured by blood test
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Timepoint [14]
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Baseline and Week 12
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Secondary outcome [15]
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Change in Nuclear Factor KappaB (NF-kB)
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Assessment method [15]
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Change in NF-kB as measured by blood test
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Timepoint [15]
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Baseline and Week 12
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Secondary outcome [16]
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Change in P-selectin
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Assessment method [16]
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Change in P-selectin as measured by blood test
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Timepoint [16]
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Baseline and Week 12
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Secondary outcome [17]
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Change in E-selectin
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Assessment method [17]
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Change in E-selectin as measured by blood test
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Timepoint [17]
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Baseline and Week 12
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Secondary outcome [18]
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Change in Matrix Metalloproteinase-3 (MMP3)
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Assessment method [18]
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Change in MMP3 as measured by blood test
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Timepoint [18]
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Baseline and Week 12
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Secondary outcome [19]
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Change in Cartilage Oligomeric Matrix Protein (COMP/thrombospondin-5)
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Assessment method [19]
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Change in COMP as measured by blood test
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Timepoint [19]
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Baseline and Week 12
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Secondary outcome [20]
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Change in Type II procollagen (CPII)
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Assessment method [20]
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Change in CPII as measured by blood test
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Timepoint [20]
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Baseline and Week 12
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Secondary outcome [21]
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Change in Type II collagen (C2C)
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Assessment method [21]
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Change in C2C as measured by blood test
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Timepoint [21]
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Baseline and Week 12
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Secondary outcome [22]
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Change in Creatine Kinase (CK)
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Assessment method [22]
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Change in CK as measured by blood test
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Timepoint [22]
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Baseline and Week 12
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Secondary outcome [23]
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Change in Myoglobin
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Assessment method [23]
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Change in Myoglobin as measured by blood test
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Timepoint [23]
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Baseline and Week 12
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Secondary outcome [24]
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Change in Full Blood Count (FBC)
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Assessment method [24]
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Change in FBC as measured by blood test
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Timepoint [24]
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Baseline and Week 12
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Secondary outcome [25]
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Change in Platelet agglomeration
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Assessment method [25]
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Change in Platelet agglomeration as measured by blood test
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Timepoint [25]
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Baseline and Week 12
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Secondary outcome [26]
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Change in Lipoprotein-associated phospholipase A2 (Lp-PLA2)
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Assessment method [26]
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Change in Lp-PLA2 as measured by blood test
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Timepoint [26]
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Baseline and Week 12
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Secondary outcome [27]
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Change in Intercellular Cell Adhesion Molecule-1 (ICAM-1)
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Assessment method [27]
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Change in ICAM-1 as measured by blood test
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Timepoint [27]
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Baseline and Week 12
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Secondary outcome [28]
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Change in Intercellular Cell Adhesion Molecule-2 (ICAM-2)
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Assessment method [28]
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Change in ICAM-2 as measured by blood test
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Timepoint [28]
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Baseline and Week 12
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Secondary outcome [29]
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Change in Vascular Cell Adhesion Molecule-1 (VCAM-1)
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Assessment method [29]
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Change in VCAM-1 as measured by blood test
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Timepoint [29]
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Baseline and Week 12
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Secondary outcome [30]
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Change in Vascular Cell Adhesion Molecule-2 (VCAM-2)
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Assessment method [30]
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Change in VCAM-2 as measured by blood test
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Timepoint [30]
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Baseline and Week 12
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Secondary outcome [31]
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Change in Platelet Endothelial Cell Adhesion Molecule-1 (PECAM-1)
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Assessment method [31]
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Change in PECAM-1 as measured by blood test
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Timepoint [31]
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Baseline and Week 12
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Secondary outcome [32]
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Change in Erythrocyte Sedimentation Rate (ESR)
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Assessment method [32]
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Change in ESR as measured by blood test
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Timepoint [32]
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Baseline and Week 12
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Secondary outcome [33]
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Change in Lactate Dehydrogenase (LDH)
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Assessment method [33]
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Change in LDH as measured by blood test
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Timepoint [33]
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Baseline and Week 12
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Secondary outcome [34]
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Change in P38 Mitogen-activated Protein Kinases (P38)
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Assessment method [34]
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Change in P38 as measured by blood test
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Timepoint [34]
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Baseline and Week 12
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Secondary outcome [35]
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Change in Electrolytes and Liver Function Tests (E/LFT)
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Assessment method [35]
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Change in E/LFT as measured by blood test
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Timepoint [35]
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Baseline and Week 12
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Secondary outcome [36]
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Change in 2 minute walk test
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Assessment method [36]
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Change in 2 minute walk test as measured by exercise testing
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Timepoint [36]
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Baseline and Week 12
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Secondary outcome [37]
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Change in sit-to-stand test
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Assessment method [37]
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Change in sit-to-stand test as measured by exercise testing
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Timepoint [37]
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Baseline and Week 12
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Secondary outcome [38]
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Change in Hand Grip Strength
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Assessment method [38]
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Change in Hand Grip Strength as measured by dynamometer
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Timepoint [38]
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Baseline and Week 12
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Secondary outcome [39]
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Change in Adverse Events
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Assessment method [39]
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Change in Adverse Events self-reported by participants
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Timepoint [39]
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12 week period from enrolment to participant conclusion
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Secondary outcome [40]
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Change in Gastrointestinal Tolerance
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Assessment method [40]
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Change in Gastrointestinal Tolerance as measured by Gastrointestinal Tolerance (GIT) Questionnaire
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Timepoint [40]
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1 week after starting product and Week 12
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Eligibility
Key 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
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Minimum age
45
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
31/07/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/07/2025
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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RDC Clinical Pty Ltd - Brisbane
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Recruitment postcode(s) [1]
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4006 - Brisbane
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
RDC Clinical Pty Ltd
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06444763
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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David Briskey, PhD
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Address
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RDC Clinical Pty Ltd
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Amanda Rao, PhD
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Address
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Country
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Phone
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+61 414 488 559
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06444763
Download to PDF