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Fermented Vegetables and Gut Microbiome Pilot Study

NCT06883994 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-12-15

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • USDA, Western Human Nutrition Research Center

    lead FED

Principal Investigators

  • Danielle G Lemay, PhD · USDA, Western Human Nutrition Research Center

  • Bess L Caswell, PhD · USDA, Western Human Nutrition Research Center

  • Mary E Kable, PhD · USDA, Western Human Nutrition Research Center

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-19
Primary Completion
2025-09-09
Completion
2025-09-09

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06883994 on ClinicalTrials.gov