M4C Nutraceutical Intervention Human Health Effects Pilot (M4C Pilot)

June 24, 2024 updated by: Joseph McGraw, Concordia University Wisconsin
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy adults

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: M4C Treatment
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.
Dietary supplement: M4C
Nutraceutical designed to enhance novel metabolic pathway activity.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: 3 months
Dexa scan for bone mineral density
3 months
Body composition
Time Frame: 3 months
Dexa scan for body fat distribution
3 months
Body composition
Time Frame: 3 months
Dexa scan for body muscle distribution
3 months
Hemoglobin A1C
Time Frame: 3 months
measured glycated hemoglobin via whole capillary blood
3 months
Resting Systolic blood pressure
Time Frame: Monthly for 3 months
measured via Omron Platinum digital upper arm blood pressure monitor
Monthly for 3 months
Resting Diastolic blood pressure
Time Frame: Monthly for 3 months
measured via Omron Platinum digital upper arm blood pressure monitor
Monthly for 3 months
Resting Pulse
Time Frame: Monthly for 3 months
measured via Omron Platinum digital upper arm blood pressure monitor
Monthly for 3 months
Blood lipids
Time Frame: Monthly for 3 months
measured via blood lipid analyzer from whole capillary blood
Monthly for 3 months
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
Monthly for 3 months
General Mental Health
Time Frame: Monthly for 3 months
User rating as follows: Excellent, Very good, Good, Fair, Poor
Monthly for 3 months
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
Monthly for 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Saliva Melatonin and Cortisol
Time Frame: 3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Concordia University Wisconsin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Tonya Bartoletti, Concordia University of Wisconsin ORSP assistant director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 17, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 17, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 17, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-FY24-293

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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