Effect of Kombucha Consumption on the Microbiome in Healthy Subjects

NCT06484504 | Completed

• 1 other identifier: 210823
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Microbiome; Inflammation; Biochemical indicators

Outcome Measures

Primary Outcomes (1)

• Change in microbiome species richness and abundance of participants at time point 2 (week 8) from baseline (week 0)

  Shotgun metagenomic sequencing will be employed on fecal samples collected at three time points in the study period to capture the microbiome profile

  Three time points which are baseline(week 0), time point 1(week 4) and time point 2 (week 8)

Secondary Outcomes (8)

• Change in fasting blood glucose levels at time point 2 from baseline (week 0)

  Baseline (week 0) and time point 2 (week 8)

• Change in fasting blood insulin levels at time point 2 (week 8) from baseline (week 0)

  Baseline (week 0) and time point 2 (week 8)

• Change in fasting blood triglycerides levels at time point 2 (week 8) from baseline (week 0)

  Baseline (week 0) and time point 2 (week 8)

• Change in fasting blood cholesterol levels at time point 2 (week 8) from baseline (week 0)

  Baseline (week 0) and time point 2 (week 8)

• Change in fasting blood glycated hemoglobin (HbA1C) at time point 2 (week 8) from baseline (week 0)

  Baseline (week 0) and time point 2 (week 8)

Study Arms (2)

Control group

NO INTERVENTION

No intervention to be administered

Kombucha group

EXPERIMENTAL

Two servings of a 16 oz commercial kombucha beverage daily for four weeks

Dietary Supplement: Kombucha beverage

Interventions

Kombucha beverage DIETARY_SUPPLEMENT

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

Kombucha group

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Typically consume low fiber/polyphenol diet (beige diet)
• BMI within 25-29.9 kg/m2

You may not qualify if:

• Eating a high fiber/polyphenol diet or taking any medication or dietary supplement, which interfere with the absorption of polyphenols
• History of gastrointestinal surgery, diabetes mellitus on medications, or other serious medical condition, such as chronic hepatic or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as systolic BP \>160mmHg, diastolic BP \> 95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, laxative abuse, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history or routine physical examination
• Is unable or unwilling to comply with the study protocol
• Using prebiotics, probiotics, yogurt, and/or any fiber supplements regularly
• Taking antibiotics or laxatives within the past 3 months
• Allergy or sensitivity to kombucha
• In the opinion of the study investigator, any subject who demonstrate a risk of non-compliance with study procedure, or one who cannot read, understand, or complete study

Sponsors & Collaborators

• University of California, San Diego: lead
• GT's Living Foods: collaborator

Study Sites (1)

UC San Diego ACTRI

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Health Behavior; Inflammation

Condition Hierarchy (Ancestors)

Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jack A Gilbert, Ph.D.

  UC San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: July 3, 2024
• Study Start: March 3, 2022
• Primary Completion: December 1, 2022
• Study Completion: April 25, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

US (1)