Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587958
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Fermented Plant-based Portfolio Diet 4 Metabolic Health
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Fermented Plant-based Portfolio Diet 4 Metabolic Health FermDiHealth
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FermDiHealth
Brief Summary:
The primary objective of this study is to evaluate the metabolic effects of a high-fiber portfolio diet based on fermented plant-based foods compared to a corresponding non-fermented plant-based diet and a control diet habitual diet This will be assessed across gut microbiome profiles highlow Prevotella focusing on cardiometabolic risk factors particularly inflammation
A total of 100 men and women who meet all inclusion criteria and none of the exclusion criteria will be invited to participate The study will employ a three-way randomized controlled cross-over design featuring six-week interventions separated by six-week washout periods Participants will attend the clinic on 15 occasions including screening visits
A total of 100 men and women who meet all inclusion criteria and none of the exclusion criteria will be invited to participate The study will employ a three-way randomized controlled cross-over design featuring six-week interventions separated by six-week washout periods Participants will attend the clinic on 15 occasions including screening visits
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None