Clinical trial NCT06476236: M4C Nutraceutical Intervention Human Health Effects Pilot
Official title: M4C Nutraceutical Intervention Human Health Effects Pilot
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Keywords: 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
Lead sponsor: Concordia University Wisconsin
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label single arm intervention pilot
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Body composition
timeFrame: 3 months
measure: Body composition
timeFrame: 3 months
measure: Body composition
timeFrame: 3 months
measure: Hemoglobin A1C
timeFrame: 3 months
measure: Resting Systolic blood pressure
timeFrame: Monthly for 3 months
measure: Resting Diastolic blood pressure
timeFrame: Monthly for 3 months
measure: Resting Pulse
timeFrame: Monthly for 3 months
measure: Blood lipids
timeFrame: Monthly for 3 months
measure: Anxiety
timeFrame: Monthly for 3 months
measure: General Mental Health
timeFrame: Monthly for 3 months
measure: Chronic Pain
timeFrame: Monthly for 3 months
Secondary outcomes:
measure: Saliva Melatonin and Cortisol
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Concordia University of Wisconsin ORSP assistant director
name: Tonya Bartoletti
role: STUDY_DIRECTOR
References: