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

Not yet recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

20

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Concordia University Wisconsin

Investigators

  • 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)

June 17, 2024

Primary Completion (Estimated)

June 17, 2025

Study Completion (Estimated)

June 17, 2025

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 26, 2024

Study Record Updates

Last Update Posted (Actual)

June 26, 2024

Last Update Submitted That Met QC Criteria

June 24, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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