Fermented Vegetables and Gut Microbiome Pilot Study

Completed · Not applicable

Conditions studied: Fermented Vegetable Intake, Fermented Vegetable Acceptability, Gut Health, Gut Microbiome, Gastrointestinal Immune Function, Microbiome

In brief

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.

Key facts

Study ID

NCT06883994

Run by

USDA, Western Human Nutrition Research Center

People needed

24

Starts

2025-03-19

Expected to finish

2025-09-09

Last updated by the study team

2025-12-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18 - 65 years
• BMI 18.5 - 39.9 kg/m2

You may not qualify if…

• 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 vegetables or cultured dairy products, such as kimchi, refrigerated fermented pickles, traditional (lacto-fermented) sauerkraut, yogurt, or kefir
• In case of less frequent consumption, defer study start such that baseline assessments are completed at least two weeks after last intake
• Unwillingness to abstain from non-study fermented foods and probiotics during the trial
• Uncomfortable with or unwilling to complete stool sample or saliva collections
• Current participation in another interventional research study
• Having fewer than 3 bowel movements per week
• Unmanaged hypertension, defined as blood pressure greater than or equal to 140/90 mmHg
• Current diagnosis of:
• Disease that affects the immune system or causes immune impairment, including HIV/AIDS
• Cancer
• Diabetes
• Asthma with daily medication
• Primary immune deficiency
• Auto-immune disease
• Chronic gastrointestinal disorder (e.g. Crohn's disease, irritable bowel syndrome, colitis, gastric ulcer)
• Chronic kidney disease
• Current use for 2 weeks or longer of:
• Any drug that affects the immune system, such as immunosuppressants, immune modifying drugs, or corticosteroids (e.g. cortisone, prednisone, methylprednisolone)

Where it is running

• USDA Western Human Nutrition Research Center — Davis, California, United States

Full record on ClinicalTrials.gov

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