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M4C Nutraceutical Intervention Human Health Effects Pilot
Sponsor: Concordia University Wisconsin
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
Conditions
Interventions
M4C
Nutraceutical designed to enhance novel metabolic pathway activity.