Ignite Creation Date:
2024-07-17 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476236
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-05
Brief Title:
M4C Nutraceutical Intervention Human Health Effects Pilot
Sponsor:
Concordia University Wisconsin
Organization:
Concordia University Wisconsin
Study Overview
Official Title:
M4C Nutraceutical Intervention Human Health Effects Pilot
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
M4C Pilot
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 musclefatwater composition and metabolitenovel 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 McGraws 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 metabolitesnovel suspected lipopeptides hemoglobin A1C or bone mineral density
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None