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NOT YET RECRUITING
NCT06476236
NA

M4C Nutraceutical Intervention Human Health Effects Pilot

Sponsor: Concordia University Wisconsin

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-06-17

Completion Date

2025-06-17

Last Updated

2024-06-26

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

M4C

Nutraceutical designed to enhance novel metabolic pathway activity.