M4C Nutraceutical Intervention Human Health Effects Pilot

NCT ID: NCT06476236

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-17
• Study Completion Date: 2025-06-17

Brief 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

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

M4C

Intervention Type: DIETARY_SUPPLEMENT

Nutraceutical designed to enhance novel metabolic pathway activity.

Interventions

M4C

Nutraceutical designed to enhance novel metabolic pathway activity.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Concordia University Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Joseph McGraw

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tonya Bartoletti

Role: STUDY_DIRECTOR

Concordia University of Wisconsin ORSP assistant director

Central Contacts

Joseph McGraw

Role: CONTACT

Joseph.McGraw@cuw.edu

412-4454 ext. 815

Kevin Gries

Role: CONTACT

Kevin.Gries@cuw.edu

243-4293 ext. 262

Other Identifiers

IRB-FY24-293

Identifier Type: -

Identifier Source: org_study_id