Trials / Not Yet Recruiting

Not Yet RecruitingNCT06476236

M4C Nutraceutical Intervention Human Health Effects Pilot

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 20 (estimated)

Sponsor: Concordia University Wisconsin · Academic / Other
Sex: All
Age: 18 Years – 80 Years
Healthy volunteers: Accepted

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 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.

Conditions

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	M4C	Nutraceutical designed to enhance novel metabolic pathway activity.

Timeline

Start date: 2024-06-17
Primary completion: 2025-06-17
Completion: 2025-06-17
First posted: 2024-06-26
Last updated: 2024-06-26

Source: ClinicalTrials.gov record NCT06476236. Inclusion in this directory is not an endorsement.