Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT06883994
Status:
COMPLETED
Last Update Posted:
2025-12-15
First Post:
2025-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fermented Vegetables and Gut Microbiome Pilot Study
Sponsor:
USDA, Western Human Nutrition Research Center
Organization:
Study Overview
Official Title:
Fermented Vegetables and Gut Microbiome Pilot Study
Status:
COMPLETED
Status Verified Date:
2025-09
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:
None
Brief Summary:
The purpose of this research is to determine the effect of fermented vegetable consumption on LAB abundance and tolerability of the intervention in young healthy people before conducting a full RCT with older participants.
Detailed Description:
The purpose of this research is to determine the tolerability of fermented vegetable consumption and its effect on lactic acid bacteria (LAB) abundance in healthy people. There is evidence from previous studies that eating fermented foods containing live microbes can affect the gut microbiome and gut health, but there is little information on the impact of fermented vegetables, specifically.
This research will expand the limited existing literature on the effect of fermented vegetable intake on LAB abundance, GI symptoms, fecal consistency and frequency.
Specific knowledge will be produced regarding the magnitude and variation in the increase in LAB bacterial load during fermented vegetable consumption and whether one week is sufficient for LAB to pass out of the gastrointestinal tract. The effect of fermented vegetable consumption on total salivary sIgA levels in healthy adults will also be determined.
The study will also produce knowledge on whether symptoms of bloating and flatulence will improve with fermented vegetables. Stool consistency, stool frequency, GI symptoms, blood pressure and product acceptability data will inform the study design for a future randomized controlled trial of the effects of fermented vegetables on gut microbiome composition and function, gut health and immune function.
The impacts of fermented vegetable consumption on the human gut microbiome, intestinal permeability, and GI inflammation will also be determined with in vitro experiments.
This research will expand the limited existing literature on the effect of fermented vegetable intake on LAB abundance, GI symptoms, fecal consistency and frequency.
Specific knowledge will be produced regarding the magnitude and variation in the increase in LAB bacterial load during fermented vegetable consumption and whether one week is sufficient for LAB to pass out of the gastrointestinal tract. The effect of fermented vegetable consumption on total salivary sIgA levels in healthy adults will also be determined.
The study will also produce knowledge on whether symptoms of bloating and flatulence will improve with fermented vegetables. Stool consistency, stool frequency, GI symptoms, blood pressure and product acceptability data will inform the study design for a future randomized controlled trial of the effects of fermented vegetables on gut microbiome composition and function, gut health and immune function.
The impacts of fermented vegetable consumption on the human gut microbiome, intestinal permeability, and GI inflammation will also be determined with in vitro experiments.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| USDA 2032-10700-002-000D | OTHER_GRANT | US Department of Agriculture (USDA) Agricultural Research Service (ARS) | View |