## Protocol Section
### Identification Module
**NCT ID:** NCT06436781

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

**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

#### Organization Study ID Info
**ID:** MAOJOI(A)
#### Organization
**Class:** INDUSTRY
**Full Name:** RDC Clinical Pty Ltd
### Status Module
#### Completion Date
**Date:** 2025-07-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-04-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-31

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** RDC Clinical Pty Ltd

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Post Exercise Inflammation

- Exercise Recovery

- Muscle Fatigue

- Muscle Pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 2 capsules containing a total of 500 mg/day active proteins taken once daily before the morning meal

**Intervention Names:**

- Drug: Maolactin

**Label:** Maolactin

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 2 capsules containing maltodextrin (0mg/day active proteins) taken once daily before the morning meal

**Intervention Names:**

- Drug: Maltodextrin

**Label:** Maltodextrin

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Maolactin

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

**Name:** Maolactin

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Maltodextrin

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

**Name:** Maltodextrin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Change in post exercise muscle breakdown as assessed by creatine kinase (CK) via blood test

**Measure:** Change in post exercise muscle breakdown

**Time Frame:** 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 Outcomes

**Description:** Change in Weight as measured by digital scales

**Measure:** Change in Weight

**Time Frame:** Baseline and Week 8

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

**Measure:** Change in Body Mass Index (BMI)

**Time Frame:** Baseline and Week 8

**Description:** Change in MSK-HQ as self-reported by participants. Scored on a range of 0-56, with a higher score indicating health status.

**Measure:** Change in Musculoskeletal Health Questionnaire (MSK-HQ)

**Time Frame:** Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))

**Description:** 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.

**Measure:** Change in Visual Analogue Scale (VAS) Muscle Pain

**Time Frame:** Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))

**Description:** Change in VAS Pain as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of pain

**Measure:** Change in Visual Analogue Scale (VAS) Pain

**Time Frame:** Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))

**Description:** Change in VAS Fatigue as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of fatigue.

**Measure:** Change in Visual Analogue Scale (VAS) Fatigue

**Time Frame:** Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))

**Description:** Change in VAS Mobility as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of mobility.

**Measure:** Change in Visual Analogue Scale (VAS) Mobility

**Time Frame:** Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))

**Description:** Change in VAS Stiffness as self-reported by participants. Minimum score = 0, Maximum score = 10. Higher scores indicate a higher level of stiffness.

**Measure:** Change in Visual Analogue Scale (VAS) Stiffness

**Time Frame:** Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))

**Description:** 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.

**Measure:** Change in Multidimensional Fatigue Inventory (MFI)

**Time Frame:** Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))

**Description:** 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).

**Measure:** Change in The Perceived Recovery Status Scale (PRSS)

**Time Frame:** Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))

**Description:** Change in BP as assessed by digital blood pressure monitor

**Measure:** Change in Blood Pressure (BP)

**Time Frame:** Baseline and Week 8

**Description:** Change in HR as assessed by digital heart rate monitor

**Measure:** Change in Heart Rate (HR)

**Time Frame:** Baseline (Time 0 and every 5 minutes until return to baseline) and Week 8 (Time 0 and every 5 minutes until return to baseline)

**Description:** Change in Oxygen Saturation as measured by pulse oximeter

**Measure:** Change in Oxygen Saturation

**Time Frame:** Baseline and Week 8

**Description:** Change in Cytokines as measured by blood test

**Measure:** Change in Cytokines

**Time Frame:** Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)

**Description:** Change in NF-kB as measured by blood test

**Measure:** Change in Nuclear Factor KappaB (NF-kB)

**Time Frame:** Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)

**Description:** Change in P-selectin as measured by blood test

**Measure:** Change in P-selectin

**Time Frame:** Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)

**Description:** Change in E-selectin as measured by blood test

**Measure:** Change in E-selectin

**Time Frame:** Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)

**Description:** Change in Lp-PLA2 as measured by blood test

**Measure:** Change in Lipoprotein-associated Phospholipase A2 (Lp-PLA2)

**Time Frame:** Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)

**Description:** Change in ICAM-1 as measured by blood test

**Measure:** Change in Intercellular Cell Adhesion Molecule-1 (ICAM-1)

**Time Frame:** Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)

**Description:** Change in ICAM-2 as measured by blood test

**Measure:** Change in Intercellular Cell Adhesion Molecule-2 (ICAM-2)

**Time Frame:** Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)

**Description:** Change in VCAM-1 as measured by blood test

**Measure:** Change in Vascular Cell Adhesion Molecule-1 (VCAM-1)

**Time Frame:** Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)

**Description:** Change in PECAM-1 as measured by blood test

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

**Time Frame:** Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)

**Description:** Change in ESR as measured by blood test

**Measure:** Change in Erythrocyte Sedimentation Rate (ESR)

**Time Frame:** Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)

**Description:** Change in LDH as measured by blood test

**Measure:** Change in Lactate Dehydrogenase (LDH)

**Time Frame:** Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)

**Description:** Change in P38 as measured by blood test

**Measure:** Change in P38 Mitogen-activated Protein Kinases (P38)

**Time Frame:** Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)

**Description:** Change in E/LFT as measured by blood test

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

**Time Frame:** Baseline (Pre-exercise and 2 hours post) and Week 8 (Pre-exercise and 2 hours post)

**Description:** Change in Lactic acid as measured by blood test

**Measure:** Change in Lactic acid

**Time Frame:** 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)

**Description:** Change in CRP as measured by blood test

**Measure:** Change in C-reactive protein (CRP)

**Time Frame:** 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)

**Description:** Change in myoglobin as measured by blood test

**Measure:** Change in myoglobin

**Time Frame:** 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)

**Description:** Change in 1 Repetition Max (1-RM) as assessed by exercise testing

**Measure:** Change in 1 Repetition Max (1-RM)

**Time Frame:** Baseline (Session 1 and Session 2 (+24 hours)) and Week 8 (Session 1, Session 2 (+24 hours))

**Description:** Change in Number of Repetitions to Fatigue as assessed by exercise testing

**Measure:** Change in Number of Repetitions to Fatigue

**Time Frame:** Baseline (Session 1 and Session 2 (+24 hours)) and Week 8 (Session 1, Session 2 (+24 hours)

**Description:** Change in Hand Grip Strength as measured by dynamometer

**Measure:** Change in Hand Grip Strength

**Time Frame:** Baseline (Session 1, Session 2 (+24 hours), Session 3 (+48 hours)) and Week 8 (Session 1, Session 2 (+24 hours), Session 3 (+48 hours))

**Description:** 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.

**Measure:** Change in BORG Perception of intensity (RPE)

**Time Frame:** Baseline (Session 1 and Session 2 (+24 hours)) and Week 8 (Session 1, Session 2 (+24 hours)

**Description:** Change in Adverse Events self-reported by participants

**Measure:** Change in Adverse Events

**Time Frame:** 8 week period from enrolment to participant conclusion

**Description:** Change in Gastrointestinal Tolerance as measured by Gastrointestinal Tolerance (GIT) Questionnaire

**Measure:** Change in Gastrointestinal Tolerance

**Time Frame:** 1 week after starting product

**Description:** Change in diet as assessed by 3 day Diet Recall

**Measure:** Change in diet

**Time Frame:** Baseline and Week 8

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** amanda@rdcglobal.com.au

**Name:** Amanda Rao, PhD

**Phone:** +61 414 488 559

**Role:** CONTACT

**Contact 2:**

**Email:** david@rdcglobal.com.au

**Name:** David Briskey, PhD

**Phone:** +61 421 784 077

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Brisbane

**Country:** Australia

**Facility:** RDC Clinical Pty Ltd

**State:** Queensland

**Zip:** 4006

#### Overall Officials

**Official 1:**

**Affiliation:** RDC Clinical Pty Ltd

**Name:** David Briskey, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000009135

- Term: Muscular Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000059352

- Term: Musculoskeletal Pain

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M10293

- Name: Inflammation

- Relevance: HIGH

- As Found: Inflammation

- ID: M8364

- Name: Fatigue

- Relevance: LOW

- As Found: Unknown

- ID: M30156

- Name: Myalgia

- Relevance: HIGH

- As Found: Muscle Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M29444

- Name: Musculoskeletal Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000063806

- Term: Myalgia

- ID: D000007249

- Term: Inflammation

### Misc Info Module

- Version Holder: 2024-05-31
