M4C Nutraceutical Intervention Human Health Effects Pilot

NCT06476236 | Not Yet Recruiting

• 1 other identifier: IRB-FY24-293
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (11)

• Body composition

  Dexa scan for bone mineral density

  3 months

• Body composition

  Dexa scan for body fat distribution

  3 months

• Body composition

  Dexa scan for body muscle distribution

  3 months

• Hemoglobin A1C

  measured glycated hemoglobin via whole capillary blood

  3 months

• Resting Systolic blood pressure

  measured via Omron Platinum digital upper arm blood pressure monitor

  Monthly for 3 months

• Resting Diastolic blood pressure

  measured via Omron Platinum digital upper arm blood pressure monitor

  Monthly for 3 months

• Resting Pulse

  measured via Omron Platinum digital upper arm blood pressure monitor

  Monthly for 3 months

• Blood lipids

  measured via blood lipid analyzer from whole capillary blood

  Monthly for 3 months

• Anxiety

  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

  User rating as follows: Excellent, Very good, Good, Fair, Poor

  Monthly for 3 months

• Chronic Pain

  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 Outcomes (1)

• Saliva Melatonin and Cortisol

  3 months

Study Arms (1)

M4C Treatment

EXPERIMENTAL

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

Interventions

M4C DIETARY_SUPPLEMENT

Nutraceutical designed to enhance novel metabolic pathway activity.

M4C Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults

You may not qualify if:

• 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

Sponsors & Collaborators

• Concordia University Wisconsin: lead

MeSH Terms

Conditions

Psychological Well-Being; Obesity

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tonya Bartoletti

  Concordia University of Wisconsin ORSP assistant director

  STUDY DIRECTOR

Central Study Contacts

Joseph McGraw

CONTACT

412-4454; Joseph.McGraw@cuw.edu

Kevin Gries

CONTACT

243-4293; Kevin.Gries@cuw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Open label single arm intervention pilot

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 26, 2024
• Study Start: June 17, 2024
• Primary Completion: June 17, 2025
• Study Completion: June 17, 2025
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share