Fermented Vegetables and Gut Microbiome Pilot Study (NCT06883994) | Clinical Trial Compass
CompletedNot Applicable
Fermented Vegetables and Gut Microbiome Pilot Study
United States24 participantsStarted 2025-03-19
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
We will enroll non-obese adults aged 18-65 years, with BMI between 18.5 and 39.9 kg/m2. We will exclude people with a high blood pressure, who cannot consume fermented vegetables, and those among whom a medical condition, use of medication, use of probiotic supplements or consumption of fermented foods may influence trial outcomes. Those who are uncomfortable with the stool sample collection protocol, or who may not be able to complete the stool samples due to infrequent bowel movements, will also be excluded.
Adults who are unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, and prisoners will be excluded from participation in the study.
Inclusion Criteria:
* Age 18 - 65 years
* BMI 18.5 - 39.9 kg/m2
Exclusion Criteria:
* BMI less than 18.5 or greater than 39.9
* Pregnant or breastfeeding
* Allergy or sensitivity to any fruit or vegetable
* Dietary restriction preventing consumption of fermented vegetables
* Consumption of probiotic supplements, foods or drinks in the past month
* Probiotic supplements include any tablets, liquids, powders, chewables or other formulations that provide high-quantity, live probiotic microbes
* Probiotic foods and drinks include products labeled as 'probiotic' because they contain live microbes in types and quantities that may confer a health benefit
* Regular consumption, defined as consumption more than once per week in the past two weeks, of live microbe-containing fermented vegetab…
What they're measuring
1
Lactic acid bacteria (LAB) cell count in stool
Timeframe: At the end of 1-week un-intervened baseline, 4-day intervention and 1-week un-intervened follow-up.
Trial details
NCT IDNCT06883994
SponsorUSDA, Western Human Nutrition Research Center