Fermented Vegetables and Gut Microbiome Pilot Study

Description

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

Study Overview

Study Details

Study overview

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.

Fermented Vegetables and Gut Microbiome Pilot Study

Fermented Vegetables and Gut Microbiome Pilot Study

Condition
Fermented Vegetable Intake
Intervention / Treatment

-

Contacts and Locations

Davis

USDA Western Human Nutrition Research Center, Davis, California, United States, 95616

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age 18 - 65 years
  • * BMI 18.5 - 39.9 kg/m2
  • * 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)
  • * Biologics (e.g. Lantus, Remicade, Rituxan, Humira, Herceptin, Avastin, Lucentis, Enbrel)
  • * GLP-1 agonists, such as semaglutide and tirzepatide.
  • * Antidiabetic medications, such as Metformin.
  • * Diuretics, such as Hydrochlorothiazide
  • * Use of sulfonamides or antimicrobials, including antibiotics, antifungals, antivirals, and antiparasitic medications in the past 3 months
  • * Use of laxatives in the past 2 weeks
  • * Currently undergoing cancer treatment with radiation or drugs
  • * History of gastrointestinal surgery that would impact study outcomes, such as gastric bypass, intestinal resection, surgeries of the liver or pancreas, or removal of part or all of any organ of the GI tract
  • * Having within the past 2 weeks:
  • * Diarrheal illness, defined as passing 3 or more abnormally loose or watery stools in a 24-hour period
  • * Persistent vomiting
  • * Fever
  • * Having within the past 3 months:
  • * Surgery
  • * Hospitalization
  • * Having within the past 1 month:
  • * Colonoscopy

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

USDA, Western Human Nutrition Research Center,

Danielle G Lemay, PhD, PRINCIPAL_INVESTIGATOR, USDA, Western Human Nutrition Research Center

Bess L Caswell, PhD, PRINCIPAL_INVESTIGATOR, USDA, Western Human Nutrition Research Center

Mary E Kable, PhD, PRINCIPAL_INVESTIGATOR, USDA, Western Human Nutrition Research Center

Study Record Dates

2025-12