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

Muscle Fatigue Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06436781
• Other study ID #: MAOJOI(A)
• Status: Not yet recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Exercise Recovery
• Inflammation
• Muscle Fatigue
• Muscle Pain
• Myalgia

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