M4C Nutraceutical Intervention Human Health Effects Pilot (M4C Pilot)

Concordia University Wisconsin

Status: Not yet enrolling

Conditions: Sleep and Relaxation; Cardiovascular Health; Anti Inflammatory; Obesity; Digestive Health; Energy and Vitality; Skin, Hair, and Nail Health; Sports Performance and Recovery; Immune Support; Bone and Joint Health; Exercise Tolerance; General Health and Wellness; Cognitive Function and Mental Health; Weight Management

Treatments: Dietary Supplement: M4C

Study type: Interventional

Funder types: Other

Identifiers

NCT06476236

IRB-FY24-293

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

M4C Treatment

Experimental group

Description:

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.

Treatment:

Dietary Supplement: M4C