Clinical trial NCT06883994: Fermented Vegetables and Gut Microbiome Pilot Study
Official title: Fermented Vegetables and Gut Microbiome Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fermented Vegetable Intake
Fermented Vegetable Acceptability
Gut Health
Gut Microbiome
Gastrointestinal Immune Function
Microbiome
Keywords: Fermented vegetables
Fermented foods
Nutrition
Adults
Immune function
Gastrointestinal (GI) health
Gut microbiome
GI tract
Lead sponsor: USDA, Western Human Nutrition Research Center
Sponsor class: FED
First posted: 2025-03-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: The purpose of this research is to determine the tolerability of fermented vegetable consumption and its effect on lactic acid bacteria (LAB) abundance in healthy people. There is evidence from previous studies that eating fermented foods containing live microbes can affect the gut microbiome and gut health, but there is little information on the impact of fermented vegetables, specifically.

This research will expand the limited existing literature on the effect of fermented vegetable intake on LAB abundance, GI symptoms, fecal consistency and frequency.

Specific knowledge will be produced regarding the magnitude and variation in the increase in LAB bacterial load during fermented vegetable consumption and whether one week is sufficient for LAB to pass out of the gastrointestinal tract. The effect of fermented vegetable consumption on total salivary sIgA levels in healthy adults will also be determined.

The study will also produce knowledge on whether symptoms of bloating and flatulence will improve with fermented vegetables. Stool consistency, stool frequency, GI symptoms, blood pressure and product acceptability data will inform the study design for a future randomized controlled trial of the effects of fermented vegetables on gut microbiome composition and function, gut health and immune function.

The impacts of fermented vegetable consumption on the human gut microbiome, intestinal permeability, and GI inflammation will also be determined with in vitro experiments.

Eligibility criteria: 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 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

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: GI symptoms
timeFrame: At the end of 1-week un-intervened baseline, 4-day intervention and 1-week un-intervened follow-up.
measure: Stool frequency
timeFrame: Throughout 1-week un-intervened baseline, 4-day intervention and 1-week un-intervened follow-up.
measure: Stool consistency
timeFrame: Throughout 1-week un-intervened baseline, 4-day intervention and 1-week un-intervened follow-up.
measure: Salivary secretory immunoglobulin A
timeFrame: At the end of 1-week un-intervened baseline, 4-day intervention and 1-week un-intervened follow-up.
Other outcomes:
measure: Acceptability of fermented vegetables
timeFrame: Throughout 4-day intervention period
measure: Blood pressure
timeFrame: At the end of 1-week un-intervened baseline, 4-day intervention and 1-week un-intervened follow-up.
measure: Gut microbiome composition
timeFrame: At the end of 1-week un-intervened baseline
measure: Intestinal permeability
timeFrame: At the end of 1-week un-intervened baseline, 4-day intervention and 1-week un-intervened follow-up.
measure: Gastrointestinal inflammation
timeFrame: At the end of 1-week un-intervened baseline, 4-day intervention and 1-week un-intervened follow-up.
Locations:
city: Davis
country: United States
facility: USDA Western Human Nutrition Research Center
state: California
Study officials:
affiliation: USDA, Western Human Nutrition Research Center
name: Danielle G Lemay, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: USDA, Western Human Nutrition Research Center
name: Bess L Caswell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: USDA, Western Human Nutrition Research Center
name: Mary E Kable, PhD
role: PRINCIPAL_INVESTIGATOR
References: