Effect of Kombucha Consumption on the Microbiome in Healthy Subjects
NCT Number: NCT06484504
Acronym: KOMICS
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Health Behavior
Interventions: DIETARY_SUPPLEMENT: Kombucha beverage
Sponsor: University of California, San Diego
Collaborators: GT's Living Foods
Sex: ALL
Age: ADULT
Enrollment: 31
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2022-03-03
Completion Date: 2024-04-25
Locations: UC San Diego ACTRI, La Jolla, California, 92037, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Change in fasting blood glucose levels at time point 2 from baseline (week 0), fasting glucose (mg/dL) will be measured from blood samples during the study, 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), Fasting insulin (μU/mL) will be measured from blood samples during the study, 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), Fasting triglycerides (mg/dL) will be measured from blood samples during the study, 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), Total cholesterol, High density lipoprotein (HDL) cholesterol and low density lipoprotein (LDL) cholesterol (mg/dL) will be measured from blood samples during the study, 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), Glycated hemoglobin (hbA1c) (%) will be measured from blood samples during the study, Baseline (week 0) and time point 2 (week 8)|Change in serum interleukin (IL)10 levels at time point 2 (week 8) from baseline (week 0), Measurement of serum interleukin (IL) 10 levels (pg/mL) by flow cytometry, Baseline (week 0), time point 1 (week 4) and time point 2 (week 8)|Change in serum interleukin (IL) 6 levels at time point 2 (week 8) from baseline (week 0), Measurement of serum interleukin (IL) 6 levels (pg/mL) by flow cytometry, Baseline (week 0), time point 1 (week 4) and time point 2 (week 8)|Change in serum C-reactive protein (CRP) levels at time point 2 (week 8) from baseline (week 0), Measurement of serum C-reactive protein (CRP) levels by flow cytometry, Baseline (week 0), time point 1 (week 4) and time point 2 (week 8)