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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06436781




Registration number
NCT06436781
Ethics application status
Date submitted
24/05/2024
Date registered
31/05/2024
Date last updated
16/10/2024

Titles & IDs
Public title
Effect of Maolactin™ FMR on Exercise Recovery, Inflammation, and Muscle Comfort in an Otherwise Healthy Population
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
Secondary ID [1] 0 0
MAOJOI(A)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Exercise Inflammation 0 0
Exercise Recovery 0 0
Muscle Fatigue 0 0
Muscle Pain 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in post exercise muscle breakdown
Timepoint [1] 0 0
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 outcome [1] 0 0
Change in Weight
Timepoint [1] 0 0
Baseline and Week 8
Secondary outcome [2] 0 0
Change in Body Mass Index (BMI)
Timepoint [2] 0 0
Baseline and Week 8
Secondary outcome [3] 0 0
Change in Musculoskeletal Health Questionnaire (MSK-HQ)
Timepoint [3] 0 0
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 outcome [4] 0 0
Change in Visual Analogue Scale (VAS) Muscle Pain
Timepoint [4] 0 0
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 outcome [5] 0 0
Change in Visual Analogue Scale (VAS) Pain
Timepoint [5] 0 0
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 outcome [6] 0 0
Change in Visual Analogue Scale (VAS) Fatigue
Timepoint [6] 0 0
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 outcome [7] 0 0
Change in Visual Analogue Scale (VAS) Mobility
Timepoint [7] 0 0
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 outcome [8] 0 0
Change in Visual Analogue Scale (VAS) Stiffness
Timepoint [8] 0 0
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 outcome [9] 0 0
Change in Multidimensional Fatigue Inventory (MFI)
Timepoint [9] 0 0
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 outcome [10] 0 0
Change in The Perceived Recovery Status Scale (PRSS)
Timepoint [10] 0 0
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 outcome [11] 0 0
Change in Blood Pressure (BP)
Timepoint [11] 0 0
Baseline and Week 8
Secondary outcome [12] 0 0
Change in Heart Rate (HR)
Timepoint [12] 0 0
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 outcome [13] 0 0
Change in Oxygen Saturation
Timepoint [13] 0 0
Baseline and Week 8
Secondary outcome [14] 0 0
Change in Cytokines
Timepoint [14] 0 0
Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
Secondary outcome [15] 0 0
Change in Nuclear Factor KappaB (NF-kB)
Timepoint [15] 0 0
Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
Secondary outcome [16] 0 0
Change in P-selectin
Timepoint [16] 0 0
Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
Secondary outcome [17] 0 0
Change in E-selectin
Timepoint [17] 0 0
Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
Secondary outcome [18] 0 0
Change in Lipoprotein-associated Phospholipase A2 (Lp-PLA2)
Timepoint [18] 0 0
Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
Secondary outcome [19] 0 0
Change in Intercellular Cell Adhesion Molecule-1 (ICAM-1)
Timepoint [19] 0 0
Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
Secondary outcome [20] 0 0
Change in Intercellular Cell Adhesion Molecule-2 (ICAM-2)
Timepoint [20] 0 0
Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
Secondary outcome [21] 0 0
Change in Vascular Cell Adhesion Molecule-1 (VCAM-1)
Timepoint [21] 0 0
Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
Secondary outcome [22] 0 0
Change in Platelet Endothelial Cell Adhesion Molecule-1 (PECAM-1)
Timepoint [22] 0 0
Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
Secondary outcome [23] 0 0
Change in Erythrocyte Sedimentation Rate (ESR)
Timepoint [23] 0 0
Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
Secondary outcome [24] 0 0
Change in Lactate Dehydrogenase (LDH)
Timepoint [24] 0 0
Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
Secondary outcome [25] 0 0
Change in P38 Mitogen-activated Protein Kinases (P38)
Timepoint [25] 0 0
Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
Secondary outcome [26] 0 0
Change in Electrolytes and Liver Function Tests (E/LFT)
Timepoint [26] 0 0
Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)
Secondary outcome [27] 0 0
Change in Lactic acid
Timepoint [27] 0 0
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 outcome [28] 0 0
Change in C-reactive protein (CRP)
Timepoint [28] 0 0
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 outcome [29] 0 0
Change in myoglobin
Timepoint [29] 0 0
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 outcome [30] 0 0
Change in 1 Repetition Max (1-RM)
Timepoint [30] 0 0
Baseline (Session 1 and Session 2 (+24 hours)) and Week 8 (Session 1, Session 2 (+24 hours))
Secondary outcome [31] 0 0
Change in Number of Repetitions to Fatigue
Timepoint [31] 0 0
Baseline (Session 1 and Session 2 (+24 hours)) and Week 8 (Session 1, Session 2 (+24 hours)
Secondary outcome [32] 0 0
Change in Hand Grip Strength
Timepoint [32] 0 0
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 outcome [33] 0 0
Change in BORG Perception of intensity (RPE)
Timepoint [33] 0 0
Baseline (Session 1 and Session 2 (+24 hours)) and Week 8 (Session 1, Session 2 (+24 hours)
Secondary outcome [34] 0 0
Change in Adverse Events
Timepoint [34] 0 0
8 week period from enrolment to participant conclusion
Secondary outcome [35] 0 0
Change in Gastrointestinal Tolerance
Timepoint [35] 0 0
1 week after starting product
Secondary outcome [36] 0 0
Change in diet
Timepoint [36] 0 0
Baseline and Week 8

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
RDC Clinical Pty Ltd - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
RDC Clinical Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT06436781
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Briskey, PhD
Address 0 0
RDC Clinical Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amanda Rao, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 414 488 559
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06436781