General Health and WellnessM4C PilotNCT06476236
M4C Nutraceutical Intervention Human Health Effects Pilot
A study testing M4C in people with General Health and Wellness and Energy and Vitality, run by Concordia University Wisconsin.
Trial summary
This 3 month pilot study will be an unblinded, convenience sampling, nutraceutical intervention trial. Twenty fasted subjects will undergo a baseline health assessment via a questionnaire, baseline clinical chemistries, blood lipids, dexa and impedence testing (to identify bone mineral density and body… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- General Health and Wellness, Energy and Vitality, Cognitive Function and Mental Health
- What is being tested?
- M4C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 17 Jun 2024to 17 Jun 2025
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
Who cannot join
- amputation
- blood clotting disorder
- metal implants or implanted electrical device(s)
- known acute or chronic illness; gastrointestinal, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension
- inability to fast i.e. low blood sugar
- pregnant or may be pregnant during the course of the study
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- amino acid metabolizing disorder i.e. phenylketonuria
- severe edema
- did not pass screening criteria as determined by MRI facility
- allergies/intolerance to any nutraceutical ingredients: amino acids, vitamins, minerals, tapioca starch, sunflower lecithin, stevia, limes or fatty acids like docosahexaenoic acid
Trial locations and contacts
No sites are listed yet.
About this study
This 3 month pilot study will be an unblinded, convenience sampling, nutraceutical intervention trial. Twenty fasted subjects will undergo a baseline health assessment via a questionnaire, baseline clinical chemistries, blood lipids, dexa and impedence testing (to identify bone mineral density and body muscle/fat/water composition), and metabolite/novel biomarker testing through whole capillary blood, saliva, and urine collections. Assessments will be repeated every month (3 times after initial assessment) to cover a 3 month period. All measurements from each visit will be compared with baseline using paired t-tests or Chi square testing depending on variable. Power analyses are not included due to the pilot nature of the study. This pilot study will provide the necessary variability estimates for future trials.
Read the detailed description
The purpose of this study is to explore potential positive human health effects of a proprietary nutraceutical formulation known as M4C. The impetus for M4C came from Dr. McGraw's attempt to alleviate the chronic inflammation a family member was experiencing through a non-invasive, natural, nutraceutical approach. Anecdotal findings of M4C show an antiinflammatory effect (observed in the presence of inflammatory conditions and after traumatic injury such as a sprain or fall), improved metabolic, gastrointestinal, and mental health, as well as enhanced exercise response and recovery. In this study the investigators will examine whether supplementation with M4C is associated with any changes in lipids, clinical chemistries, body composition, questionnaire covariates, metabolites/novel suspected lipopeptides, hemoglobin A1C, or bone mineral density.
- Conditions
- General Health and Wellness, Energy and Vitality, Cognitive Function and Mental Health, Weight Management, Digestive Health, Exercise Tolerance
- Being tested
- M4C
- Keywords
- General Health and Wellness, Energy and Vitality, Cognitive Function and Mental Health, Weight Management, Digestive Health, Exercise Tolerance, Cardiovascular Health, Bone and Joint Health, Skin, Hair, and Nail Health, Immune Support, Sports Performance and Recovery, Sleep and relaxation, Obesity, anti inflammatory
- Medical subject headings
- Psychological Well-Being, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M4CDietary supplement
Nutraceutical designed to enhance novel metabolic pathway activity.
| Study group | Role | What they receive |
|---|---|---|
| M4C Treatment | Experimental | Single arm study with nutraceutical M4C treatment. Proprietary blend of amino acids, fatty acids, vitamins, and minerals. 1 tbsp in 12 oz of water with two algae oil capsules taken by mouth one to two times daily. Receives: Dietary Supplement: M4C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
Dexa scan for bone mineral density
Measured: 3 months
Body composition
Dexa scan for body fat distribution
Measured: 3 months
Body composition
Dexa scan for body muscle distribution
Measured: 3 months
Hemoglobin A1C
measured glycated hemoglobin via whole capillary blood
Measured: 3 months
Resting Systolic blood pressure
measured via Omron Platinum digital upper arm blood pressure monitor
Measured: Monthly for 3 months
Resting Diastolic blood pressure
measured via Omron Platinum digital upper arm blood pressure monitor
Measured: Monthly for 3 months
Resting Pulse
measured via Omron Platinum digital upper arm blood pressure monitor
Measured: Monthly for 3 months
Blood lipids
measured via blood lipid analyzer from whole capillary blood
Measured: Monthly for 3 months
Anxiety
Measured via Generalized Anxiety Disorder (GAD-7) questionnaire Scoring as follows 0-4: No anxiety, 5-9:Mild anxiety, 10-14:Moderate anxiety, 15-21: Severe anxiety
Measured: Monthly for 3 months
General Mental Health
User rating as follows: Excellent, Very good, Good, Fair, Poor
Measured: Monthly for 3 months
Chronic Pain
Self reported chronic pain as follows: Self rated from 0-10 Zero is no pain, 10 is worst pain imaginable
Measured: Monthly for 3 months
Secondary outcomes (1)
Saliva Melatonin and Cortisol
Concentrations of melatonin and cortisol in saliva (ng/ml) will be collected before bedtime and at rising. Sample melatonin and cortisol will be measured via High Performance liquid chromatography with mass spectrometry (HPLC MS/MS) as potential markers of stress state. Values will be assessed for conformance to reported reference ranges in the literature. Values outside the reference ranges will be considered positive for unhealthy stress response.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start17 Jun 2024 (estimated)
- Primary completion17 Jun 2025 (estimated)
- Study completion17 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Health and WellnessStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label single arm intervention pilot
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Concordia University Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph McGraw, Concordia University Wisconsin
- Investigators
- Tonya Bartoletti, Study director, Concordia University of Wisconsin ORSP assistant director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476236
- Sponsor's protocol ID
- IRB-FY24-293
- Acronym
- M4C Pilot
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- M4C Nutraceutical Intervention Human Health Effects Pilot
- ClinicalTrials.gov ID
- NCT06476236
- Acronym / sponsor ID
- M4C Pilot / IRB-FY24-293
- Conditions
- General Health and Wellness, Energy and Vitality, Cognitive Function and Mental Health, Weight Management, Digestive Health, Exercise Tolerance
- Keywords
- General Health and Wellness, Energy and Vitality, Cognitive Function and Mental Health, Weight Management, Digestive Health, Exercise Tolerance, Cardiovascular Health, Bone and Joint Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Concordia University WisconsinUniversity, hospital or other
- Study start
- 17 Jun 2024 (estimated)
- Primary completion
- 17 Jun 2025 (estimated)
- Study completion
- 17 Jun 2025 (estimated)
- First posted
- 26 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 3 month pilot study will be an unblinded, convenience sampling, nutraceutical intervention trial. Twenty fasted subjects will undergo a baseline health assessment via a questionnaire, baseline clinical chemistries, blood lipids, dexa and impedence testing (to identify bone mineral density and body muscle/fat/water composition), and metabolite/novel biomarker testing through whole capillary blood, saliva, and urine collections. Assessments will be repeated every month (3 times after initial assessment) to cover a 3 month period. All measurements from each visit will be compared with baseline using paired t-tests or Chi square testing depending on variable. Power analyses are not included due to the pilot nature of the study. This pilot study will provide the necessary variability estimates for future trials.
Detailed description
The purpose of this study is to explore potential positive human health effects of a proprietary nutraceutical formulation known as M4C. The impetus for M4C came from Dr. McGraw's attempt to alleviate the chronic inflammation a family member was experiencing through a non-invasive, natural, nutraceutical approach. Anecdotal findings of M4C show an antiinflammatory effect (observed in the presence of inflammatory conditions and after traumatic injury such as a sprain or fall), improved metabolic, gastrointestinal, and mental health, as well as enhanced exercise response and recovery. In this study the investigators will examine whether supplementation with M4C is associated with any changes in lipids, clinical chemistries, body composition, questionnaire covariates, metabolites/novel suspected lipopeptides, hemoglobin A1C, or bone mineral density.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label single arm intervention pilot
| Arm | Type | Receives |
|---|---|---|
| M4C Treatment | Experimental | Dietary Supplement: M4CSingle arm study with nutraceutical M4C treatment. Proprietary blend of amino acids, fatty acids, vitamins, and minerals. 1 tbsp in 12 oz of water with two algae oil capsules taken by mouth one to two times daily. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults
Key exclusion criteria (10 listed)
- amputation
- blood clotting disorder
- metal implants or implanted electrical device(s)
- known acute or chronic illness; gastrointestinal, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension
- inability to fast i.e. low blood sugar
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 |
|---|---|---|
| M4CNutraceutical designed to enhance novel metabolic pathway activity. | Dietary supplement | M4C Treatment |
Primary outcome
Body composition
Time frame: 3 months
Dexa scan for bone mineral density
Body composition
Time frame: 3 months
Dexa scan for body fat distribution
Body composition
Time frame: 3 months
Dexa scan for body muscle distribution
Hemoglobin A1C
Time frame: 3 months
measured glycated hemoglobin via whole capillary blood
Resting Systolic blood pressure
Time frame: Monthly for 3 months
measured via Omron Platinum digital upper arm blood pressure monitor
Resting Diastolic blood pressure
Time frame: Monthly for 3 months
measured via Omron Platinum digital upper arm blood pressure monitor
Resting Pulse
Time frame: Monthly for 3 months
measured via Omron Platinum digital upper arm blood pressure monitor
Blood lipids
Time frame: Monthly for 3 months
measured via blood lipid analyzer from whole capillary blood
Anxiety
Time frame: Monthly for 3 months
Measured via Generalized Anxiety Disorder (GAD-7) questionnaire Scoring as follows 0-4: No anxiety, 5-9:Mild anxiety, 10-14:Moderate anxiety, 15-21: Severe anxiety
General Mental Health
Time frame: Monthly for 3 months
User rating as follows: Excellent, Very good, Good, Fair, Poor
Chronic Pain
Time frame: Monthly for 3 months
Self reported chronic pain as follows: Self rated from 0-10 Zero is no pain, 10 is worst pain imaginable
1 secondary outcome
Saliva Melatonin and Cortisol
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Tonya Bartoletti study director
Concordia University of Wisconsin ORSP assistant director
Questions about this trial
What is this clinical trial studying?
A study testing M4C in people with General Health and Wellness and Energy and Vitality, run by Concordia University Wisconsin.
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 1 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joseph McGraw (412-4454 ext. 815, Joseph.McGraw@cuw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: 3 months). The study lists 11 primary outcomes in all. 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 26 Jun 2024; AzTrials last refreshed its copy on 31 Oct 2026.