Chronic InflammationPhase 3NCT06444763
Effect of Maolactin™ FMR on Exercise Recovery, Inflammation and Muscle Comfort in an Otherwise Healthy Population
A Phase 3 study testing Maolactin and Maltodextrin in people with Chronic Inflammation and Mobility, run by RDC Clinical Pty Ltd at 1 site in Australia.
Trial 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 over 45 years old over 10 weeks with 8 weeks supplementation. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Inflammation, Mobility, Muscle Pain
- What is being tested?
- Maolactin and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteAustralia
- Study dates
- 27 Feb 2025to 16 Feb 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 45 years and older
- 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
Who cannot join
- 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
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- 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
- 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.
- An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity.
- An unstable intake is any dose that has changed by more than 10% of the previous dose in the past 4-weeks
Trial locations and contacts
1 site in 1 country.
About this study
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
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 over 45 years old over 10 weeks with 8 weeks supplementation.
This is PART B of the study.
- Conditions
- Chronic Inflammation, Mobility, Muscle Pain, Joint Pain
- Being tested
- Maolactin, Maltodextrin
- Medical subject headings
- Myalgia, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MaolactinDrug
Once daily dose of 2 capsules containing a total of 500mg/day Maolactin
MaltodextrinDrug
Once daily dose of 2 capsules of Maltodextrin containing a total of 0mg/day Maolactin
| Study group | Role | What they receive |
|---|---|---|
| Maolactin | Experimental | 2 capsules containing a total of 500 mg/day active proteins taken once daily before the morning meal Receives: Drug: Maolactin |
| Maltodextrin | Placebo comparator | 2 capsules containing maltodextrin (0mg/day active proteins) taken once daily before the morning meal Receives: Drug: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Inflammatory status
Change in Inflammatory status as assessed by C-reactive protein (CRP) via blood test
Measured: Baseline and Week 8
Secondary outcomes (40)
Change in Weight
Change in Weight as measured by digital scales
Measured: Baseline and Week 8
Change in Body Mass Index (BMI)
Change in BMI as assessed by digital scale for weight and stadiometer for height
Measured: Baseline and Week 8
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.
Measured: Baseline, Week 4 and Week 8
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.
Measured: Baseline, Week 4 and Week 8
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
Measured: Baseline, Week 4 and Week 8
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.
Measured: Baseline, Week 4 and Week 8
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.
Measured: Baseline, Week 4 and Week 8
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.
Measured: Baseline, Week 4 and Week 8
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.
Measured: Baseline, Week 4 and Week 8
Change in Blood Pressure (BP)
Change in BP as assessed by digital blood pressure monitor
Measured: Baseline and Week 8
Change in Heart Rate (HR)
Change in HR as assessed by digital heart rate monitor
Measured: Baseline and Week 8
Change in Oxygen Saturation
Change in Oxygen Saturation as measured by pulse oximeter
Measured: Baseline and Week 8
Change in Cytokines
Change in Cytokines as measured by blood test
Measured: Baseline and Week 8
Change in Monocyte Chemotactic Protein-1 (MCP-1)
Change in MCP-1 as measured by blood test
Measured: Baseline and Week 8
Change in Nuclear Factor KappaB (NF-kB)
Change in NF-kB as measured by blood test
Measured: Baseline and Week 8
Change in P-selectin
Change in P-selectin as measured by blood test
Measured: Baseline and Week 8
Change in E-selectin
Change in E-selectin as measured by blood test
Measured: Baseline and Week 8
Change in Matrix Metalloproteinase-3 (MMP3)
Change in MMP3 as measured by blood test
Measured: Baseline and Week 8
Change in Cartilage Oligomeric Matrix Protein (COMP/thrombospondin-5)
Change in COMP as measured by blood test
Measured: Baseline and Week 8
Change in Type II procollagen (CPII)
Change in CPII as measured by blood test
Measured: Baseline and Week 8
Change in Type II collagen (C2C)
Change in C2C as measured by blood test
Measured: Baseline and Week 8
Change in Creatine Kinase (CK)
Change in CK as measured by blood test
Measured: Baseline and Week 8
Change in Myoglobin
Change in Myoglobin as measured by blood test
Measured: Baseline and Week 8
Change in Full Blood Count (FBC)
Change in FBC as measured by blood test
Measured: Baseline and Week 8
Change in Platelet agglomeration
Change in Platelet agglomeration as measured by blood test
Measured: Baseline and Week 8
Change in Lipoprotein-associated phospholipase A2 (Lp-PLA2)
Change in Lp-PLA2 as measured by blood test
Measured: Baseline and Week 8
Change in Intercellular Cell Adhesion Molecule-1 (ICAM-1)
Change in ICAM-1 as measured by blood test
Measured: Baseline and Week 8
Change in Intercellular Cell Adhesion Molecule-2 (ICAM-2)
Change in ICAM-2 as measured by blood test
Measured: Baseline and Week 8
Change in Vascular Cell Adhesion Molecule-1 (VCAM-1)
Change in VCAM-1 as measured by blood test
Measured: Baseline and Week 8
Change in Vascular Cell Adhesion Molecule-2 (VCAM-2)
Change in VCAM-2 as measured by blood test
Measured: Baseline and Week 8
Change in Platelet Endothelial Cell Adhesion Molecule-1 (PECAM-1)
Change in PECAM-1 as measured by blood test
Measured: Baseline and Week 8
Change in Erythrocyte Sedimentation Rate (ESR)
Change in ESR as measured by blood test
Measured: Baseline and Week 8
Change in Lactate Dehydrogenase (LDH)
Change in LDH as measured by blood test
Measured: Baseline and Week 8
Change in P38 Mitogen-activated Protein Kinases (P38)
Change in P38 as measured by blood test
Measured: Baseline and Week 8
Change in Electrolytes and Liver Function Tests (E/LFT)
Change in E/LFT as measured by blood test
Measured: Baseline and Week 8
Change in 2 minute walk test
Change in 2 minute walk test as measured by exercise testing
Measured: Baseline and Week 8
Change in sit-to-stand test
Change in sit-to-stand test as measured by exercise testing
Measured: Baseline and Week 8
Change in Hand Grip Strength
Change in Hand Grip Strength as measured by dynamometer
Measured: Baseline and Week 8
Change in Adverse Events
Change in Adverse Events self-reported by participants
Measured: Baseline to week 8
Change in Gastrointestinal Tolerance
Change in Gastrointestinal Tolerance as measured by Gastrointestinal Tolerance (GIT) Questionnaire
Measured: 1 week after starting product and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start27 Feb 2025
- Primary completion16 Feb 2026
- Study completion16 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic InflammationStudies of the same condition, open and under way.
- More trials run by RDC Clinical Pty LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- RDC Clinical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Briskey, PhD, Principal investigator, RDC Clinical Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444763
- Sponsor's protocol ID
- MAOJOI(B)
- Status last verified
- Jul 2025
- First submitted
- 24 May 2024
- Last updated
- 6 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06444763
- Acronym / sponsor ID
- MAOJOI(B)
- Conditions
- Chronic Inflammation, Mobility, Muscle Pain, Joint Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- RDC Clinical Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 16 Feb 2026 (actual)
- Study completion
- 16 Feb 2026 (actual)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 over 45 years old over 10 weeks with 8 weeks supplementation.
This is PART B of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maolactin | Experimental | Drug: Maolactin2 capsules containing a total of 500 mg/day active proteins taken once daily before the morning meal |
| Maltodextrin | Placebo comparator | Drug: Maltodextrin2 capsules containing maltodextrin (0mg/day active proteins) taken once daily before the morning meal |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults 45 years and older
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MaolactinOnce daily dose of 2 capsules containing a total of 500mg/day Maolactin | Drug | Maolactin |
| MaltodextrinOnce daily dose of 2 capsules of Maltodextrin containing a total of 0mg/day Maolactin | Drug | Maltodextrin |
Primary outcome
Change in Inflammatory status
Time frame: Baseline and Week 8
Change in Inflammatory status as assessed by C-reactive protein (CRP) via blood test
40 secondary outcomes
Change in Weight
Time frame: Baseline and Week 8
Change in Body Mass Index (BMI)
Time frame: Baseline and Week 8
Change in Musculoskeletal Health Questionnaire (MSK-HQ)
Time frame: Baseline, Week 4 and Week 8
Change in Visual Analogue Scale (VAS) Muscle Pain
Time frame: Baseline, Week 4 and Week 8
Change in Visual Analogue Scale (VAS) Pain
Time frame: Baseline, Week 4 and Week 8
Change in Visual Analogue Scale (VAS) Fatigue
Time frame: Baseline, Week 4 and Week 8
Change in Visual Analogue Scale (VAS) Mobility
Time frame: Baseline, Week 4 and Week 8
Change in Visual Analogue Scale (VAS) Stiffness
Time frame: Baseline, Week 4 and Week 8
Change in Multidimensional Fatigue Inventory (MFI)
Time frame: Baseline, Week 4 and Week 8
Change in Blood Pressure (BP)
Time frame: Baseline and Week 8
Change in Heart Rate (HR)
Time frame: Baseline and Week 8
Change in Oxygen Saturation
Time frame: Baseline and Week 8
Change in Cytokines
Time frame: Baseline and Week 8
Change in Monocyte Chemotactic Protein-1 (MCP-1)
Time frame: Baseline and Week 8
Change in Nuclear Factor KappaB (NF-kB)
Time frame: Baseline and Week 8
Change in P-selectin
Time frame: Baseline and Week 8
Change in E-selectin
Time frame: Baseline and Week 8
Change in Matrix Metalloproteinase-3 (MMP3)
Time frame: Baseline and Week 8
Change in Cartilage Oligomeric Matrix Protein (COMP/thrombospondin-5)
Time frame: Baseline and Week 8
Change in Type II procollagen (CPII)
Time frame: Baseline and Week 8
Change in Type II collagen (C2C)
Time frame: Baseline and Week 8
Change in Creatine Kinase (CK)
Time frame: Baseline and Week 8
Change in Myoglobin
Time frame: Baseline and Week 8
Change in Full Blood Count (FBC)
Time frame: Baseline and Week 8
Change in Platelet agglomeration
Time frame: Baseline and Week 8
Change in Lipoprotein-associated phospholipase A2 (Lp-PLA2)
Time frame: Baseline and Week 8
Change in Intercellular Cell Adhesion Molecule-1 (ICAM-1)
Time frame: Baseline and Week 8
Change in Intercellular Cell Adhesion Molecule-2 (ICAM-2)
Time frame: Baseline and Week 8
Change in Vascular Cell Adhesion Molecule-1 (VCAM-1)
Time frame: Baseline and Week 8
Change in Vascular Cell Adhesion Molecule-2 (VCAM-2)
Time frame: Baseline and Week 8
Change in Platelet Endothelial Cell Adhesion Molecule-1 (PECAM-1)
Time frame: Baseline and Week 8
Change in Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline and Week 8
Change in Lactate Dehydrogenase (LDH)
Time frame: Baseline and Week 8
Change in P38 Mitogen-activated Protein Kinases (P38)
Time frame: Baseline and Week 8
Change in Electrolytes and Liver Function Tests (E/LFT)
Time frame: Baseline and Week 8
Change in 2 minute walk test
Time frame: Baseline and Week 8
Change in sit-to-stand test
Time frame: Baseline and Week 8
Change in Hand Grip Strength
Time frame: Baseline and Week 8
Change in Adverse Events
Time frame: Baseline to week 8
Change in Gastrointestinal Tolerance
Time frame: 1 week after starting product and Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Briskey, PhD principal investigator
RDC Clinical Pty Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Maolactin and Maltodextrin in people with Chronic Inflammation and Mobility, run by RDC Clinical Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Inflammatory status (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.