NCT06883994

Fermented Vegetables and Gut Microbiome Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: USDA, Western Human Nutrition Research Center · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fermented Vegetable Intake
• Fermented Vegetable Acceptability
• Gut Health
• Gut Microbiome
• Gastrointestinal Immune Function
• Microbiome

Interventions

Type	Name	Description
OTHER	Fermented vegetable intervention	Participants will be provided with reduced-sodium fermented vegetables developed by Dr. Ilenys Pérez-Díaz at the USDA-ARS Food Science and Market Quality and Handling Research Unit. The fermented, refrigerated vegetables have been shown to have Lactiplantibacillus spp. content \>10\^7 CFU/mL at 21 days shelf-life. Products are prepared in a Good Manufacturing Practices Facility at North Carolina State University, Department of Food, Bioprocessing, and Nutrition Sciences. The fermented vegetables will be shipped in coolers on cold packs with temperature indicators to the WHNRC. Participants will be asked to consume two pre-packaged 50g servings of fermented vegetables a day, for a total daily serving of 100g, not to heat the fermented vegetables prior to consumption, to log their consumption and to rate the acceptability of the fermented vegetables. They will be advised to avoid other fermented foods and to otherwise maintain their habitual diet.

Timeline

• Start date: 2025-03-19
• Primary completion: 2025-09-09
• Completion: 2025-09-09
• First posted: 2025-03-19
• Last updated: 2025-12-15

Locations

1 site across 1 country: United States