Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06436781
Other study ID # MAOJOI(A)
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 post exercise inflammation, exercise recovery and muscle fatigue and pain in an otherwise healthy population of adults 18-65 years old over 10 weeks with 8 weeks of supplementation. This is PART A of the study.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date July 31, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Adults 18-65 years old - Generally healthy - BMI 19.0 - 29.9 kg/m2 - Able to provide informed consent - Generally active, low to moderately trained (with a minimum of 1 resistance exercise sessions per week) - 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: - Undertaking high intensity exercise training and or undertaking more than 3 days of resistance training per week. - 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 post exercise muscle breakdown Change in post exercise muscle breakdown as assessed by creatine kinase (CK) via blood test Baseline (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise) and Week 8 (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise)
Secondary Change in Weight Change in Weight as measured by digital scales Baseline and Week 8
Secondary Change in Body Mass Index (BMI) Change in BMI as assessed by digital scale for weight and stadiometer for height Baseline and Week 8
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 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))
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 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))
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 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))
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 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))
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 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))
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 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))
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 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))
Secondary Change in The Perceived Recovery Status Scale (PRSS) Change in PRSS as self-reported by participants. A single-item, 0 to 10 point scale where 0 = very poorly recovered (poor performance) and 10 = fully recovered (optimal performance). Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))
Secondary Change in Blood Pressure (BP) Change in BP as assessed by digital blood pressure monitor Baseline and Week 8
Secondary Change in Heart Rate (HR) Change in HR as assessed by digital heart rate monitor Baseline (Time 0 and every 5 minutes until return to baseline) and Week 8 (Time 0 and every 5 minutes until return to baseline)
Secondary Change in Oxygen Saturation Change in Oxygen Saturation as measured by pulse oximeter Baseline and Week 8
Secondary Change in Cytokines Change in Cytokines as measured by blood test Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
Secondary Change in Nuclear Factor KappaB (NF-kB) Change in NF-kB as measured by blood test Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
Secondary Change in P-selectin Change in P-selectin as measured by blood test Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
Secondary Change in E-selectin Change in E-selectin as measured by blood test Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
Secondary Change in Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Change in Lp-PLA2 as measured by blood test Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
Secondary Change in Intercellular Cell Adhesion Molecule-1 (ICAM-1) Change in ICAM-1 as measured by blood test Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
Secondary Change in Intercellular Cell Adhesion Molecule-2 (ICAM-2) Change in ICAM-2 as measured by blood test Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
Secondary Change in Vascular Cell Adhesion Molecule-1 (VCAM-1) Change in VCAM-1 as measured by blood test Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
Secondary Change in Platelet Endothelial Cell Adhesion Molecule-1 (PECAM-1) Change in PECAM-1 as measured by blood test Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
Secondary Change in Erythrocyte Sedimentation Rate (ESR) Change in ESR as measured by blood test Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
Secondary Change in Lactate Dehydrogenase (LDH) Change in LDH as measured by blood test Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
Secondary Change in P38 Mitogen-activated Protein Kinases (P38) Change in P38 as measured by blood test Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
Secondary Change in Electrolytes and Liver Function Tests (E/LFT) Change in E/LFT as measured by blood test Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
Secondary Change in Lactic acid Change in Lactic acid as measured by blood test Baseline (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise) and Week 8 (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise)
Secondary Change in C-reactive protein (CRP) Change in CRP as measured by blood test Baseline (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise) and Week 8 (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise)
Secondary Change in myoglobin Change in myoglobin as measured by blood test Baseline (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise) and Week 8 (Pre-exercise and 0, 1, 2, 24 and 48 hours post exercise)
Secondary Change in 1 Repetition Max (1-RM) Change in 1 Repetition Max (1-RM) as assessed by exercise testing Baseline (Session 1 and Session 2 (+24 hours)) and Week 8 (Session 1, Session 2 (+24 hours))
Secondary Change in Number of Repetitions to Fatigue Change in Number of Repetitions to Fatigue as assessed by exercise testing Baseline (Session 1 and Session 2 (+24 hours)) and Week 8 (Session 1, Session 2 (+24 hours)
Secondary Change in Hand Grip Strength Change in Hand Grip Strength as measured by dynamometer Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))
Secondary Change in BORG Perception of intensity (RPE) Change in BORG Perception of intensity (RPE) as self-reported by participants. Rates exertion from a scale of 6 (no exertion) to 20 (maximum effort). A rating between 12 to 14 typically reflects a moderate or somewhat hard level of intensity. Baseline (Session 1 and Session 2 (+24 hours)) and Week 8 (Session 1, Session 2 (+24 hours)
Secondary Change in Adverse Events Change in Adverse Events self-reported by participants 8 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
Secondary Change in diet Change in diet as assessed by 3 day Diet Recall Baseline and Week 8
See also
  Status Clinical Trial Phase
Completed NCT05077046 - Efficacy of an Ergonomic Handwriting Pen - The AWP Pen Study N/A
Recruiting NCT05073224 - Muscle Function After Childbirth N/A
Completed NCT03576391 - The Influence of Fatigue on Trunk Motor Control and Brain Activity N/A
Recruiting NCT05528250 - The Effect of Quadriceps Muscle Fatigue on Balance
Completed NCT02923102 - Effects of Recoverben® on Recovery After Exhaustive Exercise N/A
Completed NCT01962298 - Recovery of Diaphragmatic Function After Neuromuscular Blockade and Sugammadex Phase 3
Recruiting NCT03460639 - Administration of Low-level Laser on Muscles of Mastication Following the Induction of Initial Fatigue N/A
Enrolling by invitation NCT04367727 - Effect of Light Emitting Diode Therapy on Muscle Fatigue N/A
Completed NCT05862987 - The Effect of Hydrogen Rich Water Intake on Acute Body Response and Following Recovery After 5 km Run in Untrained Men N/A
Completed NCT01932281 - SierraSil Joint Formula 14 as an Ergogenic Aid to Performance in Athletes N/A
Recruiting NCT01764620 - Effects of Muscle Fatigue and a Taping Technique on Shoulder Motion of Athletes N/A
Recruiting NCT06406764 - Effects of a Plyometric Training Program on Youths With Different Biological Maturity in Sport N/A
Completed NCT03186573 - Effect of Grape Juice Consumption on the Parameters of Oxidative Stress and Muscle Fatigue in Judo Athletes N/A
Recruiting NCT03998280 - The Effect Of Cervical Muscle Fatigue in Neck Proprioception and Postural Stability
Not yet recruiting NCT02691806 - New Indices for Prediction of Human Fatigue During Training Based on Non-invasive Methods N/A
Completed NCT03863340 - Short Interventions to Prevent Trapezius Muscle Fatigue in Computer Work N/A
Completed NCT02014233 - Short Term Omega-3 Supplementation on Performance N/A
Completed NCT03712592 - Physiological Constraints Associated With Trail Running N/A
Recruiting NCT04082156 - The Effect of Transcutaneous Electrical Nerve Stimulation on People With Muscle Fatigue Due to Training, Sports N/A
Completed NCT04415099 - Tibialis Posterior Fatigue and Plantar Pressure N/A