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M4C Nutraceutical Intervention Human Health Effects Pilot

NCT06476236 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-06-26

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

M4C

Nutraceutical designed to enhance novel metabolic pathway activity.

Sponsors & Collaborators

  • Concordia University Wisconsin

    lead OTHER

Principal Investigators

  • Tonya Bartoletti · Concordia University of Wisconsin ORSP assistant director

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-17
Primary Completion
2025-06-17
Completion
2025-06-17

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06476236 on ClinicalTrials.gov