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Effect of Kombucha Consumption on the Microbiome in Healthy Subjects

NCT06484504 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-07-03

No results posted yet for this study

Summary

This proposed pilot study will assess the ability of consumption of two servings of kombucha daily to decrease inflammation, alter the gut microbiome composition, and improve intestinal wellbeing in a free-living population. The primary objective is to determine changes in the fecal microbiome composition. Secondary outcomes will be bacterial metabolites (fecal indole propionic acid, calprotectin), serum interleukin (IL) 6, interleukin (IL) 10, C-reactive protein (CRP), C-peptide, insulin, fasting glucose, Homeostatic Model Assessment for Insulin Resistance (HOMA), 14-day continuous glucose monitor, digestive health, dietary information, general Health \& Wellness at 4 and 8 weeks.

Conditions

  • Health Behavior

Interventions

DIETARY_SUPPLEMENT

Kombucha beverage

After 4-weeks of consuming a beige diet (i.e. low-fiber, low polyphenol diet), 20 subjects (kombucha group) will consume one bottle (two servings) of kombucha daily for 4 weeks and 10 subjects (control group) will not change their dietary habits

Sponsors & Collaborators

Principal Investigators

  • Jack A Gilbert, Ph.D. · UC San Diego

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-03
Primary Completion
2022-12-01
Completion
2024-04-25

Countries

  • United States

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06484504 on ClinicalTrials.gov