Fermented Vegetables and Gut Microbiome Pilot Study

USDA, Western Human Nutrition Research Center

Status: Completed

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

Treatments: Other: Fermented vegetable intervention

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT06883994

USDA 2032-10700-002-000D (Other Grant/Funding Number)

FL125

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Fermented vegetable consumption

Experimental group

Description:

Participants will complete a 1-week baseline with no fermented food intake, followed by a 4-day fermented vegetable intervention, and then a 1-week follow-up period with no fermented food intake.

Treatment:

Other: Fermented vegetable intervention