COMPLETED

Fermented Vegetables and Gut Microbiome Pilot Study

Conditions

Fermented Vegetable Intake Fermented Vegetable Acceptability Gut Health Gut Microbiome Gastrointestinal Immune Function Microbiome Fermented vegetables Fermented foods Nutrition Adults Immune function Gastrointestinal (GI) health GI tract

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Fermented Vegetables and Gut Microbiome Pilot Study

Quick Facts

Study Start:2025-03-19

Study Completion:2025-09-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06883994

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.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

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 Locations (Sites)

USDA Western Human Nutrition Research Center

Davis, California, 95616

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-19

Study Completion Date2025-09-09

Study Record Updates

Study Start Date2025-03-19

Study Completion Date2025-09-09

Terms related to this study

Keywords Provided by Researchers

Fermented vegetables
Fermented foods
Nutrition
Adults
Immune function
Gastrointestinal (GI) health
Gut microbiome
GI tract

Additional Relevant MeSH Terms

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