UC San Diego ACTRI
La Jolla, California, 92037, United States
NCT Number: NCT06484504
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.
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Notify Me21 year–55 year
All sexes
Interventional
Not applicable
La Jolla, California, 92037, United States
An altered intestinal gut microbiota, i.e. dysbiosis, has been associated with the development of intestinal disease including inflammatory bowel disease and metabolic diseases such as obesity, type 2 diabetes mellitus (T2DM), and cardiovascular disease. Fermented foods such as Kefir, Kombucha, Miso, and Kimchi contain potentially probiotic microorganisms. The characteristic microbiome in kombucha includes several genera of acetic acid bacteria, yeasts and lactic acid bacteria. Interactions between bacteria and yeast species can lead to the generation of a wide range of metabolites with interesting bioactivities such as organic acids, sugars, phenolic compounds. Kombucha produced from green and black tea contain many phenolic compounds, which contribute to its antioxidant and anti-inflammatory activity and effect on the intestinal microbiota. However, there is a lack of intervention trials investigating the health benefits of fermented foods. Therefore, the investigators propose a human intervention study to assess if daily consumption of two servings of kombucha will alter the intestinal microbiota, decrease inflammation, and improve digestive health in a two-phase design in a free-living population.
This will be a randomized, controlled, two arm intervention study. The study will be conducted in 30 healthy, free-living subjects (21-55 years). After 4-weeks of consuming a beige diet (i.e. low-fiber, low polyphenol diet), 20 subjects will consume one bottle (two servings) of kombucha daily for 4 weeks and 10 subjects will not change their dietary habits. At baseline (week 0), week 4 and 8, blood will be collected. On the day prior to the study visits at week 4 and 8, participants will collect a stool and bring it to the lab. On the day of study visit week 0, 4, and 8, body weight and composition will be determined, and questionnaires and 3-day food record will be collected.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Three time points which are baseline(week 0), time point 1(week 4) and time point 2 (week 8)
Shotgun metagenomic sequencing will be employed on fecal samples collected at three time points in the study period to capture the microbiome profile
Time frame: Baseline (week 0) and time point 2 (week 8)
fasting glucose (mg/dL) will be measured from blood samples during the study
Time frame: Baseline (week 0) and time point 2 (week 8)
Fasting insulin (μU/mL) will be measured from blood samples during the study
Time frame: Baseline (week 0) and time point 2 (week 8)
Fasting triglycerides (mg/dL) will be measured from blood samples during the study
Time frame: Baseline (week 0) and time point 2 (week 8)
Total cholesterol, High density lipoprotein (HDL) cholesterol and low density lipoprotein (LDL) cholesterol (mg/dL) will be measured from blood samples during the study
Time frame: Baseline (week 0) and time point 2 (week 8)
Glycated hemoglobin (hbA1c) (%) will be measured from blood samples during the study
Time frame: Baseline (week 0), time point 1 (week 4) and time point 2 (week 8)
Measurement of serum interleukin (IL) 10 levels (pg/mL) by flow cytometry
Time frame: Baseline (week 0), time point 1 (week 4) and time point 2 (week 8)
Measurement of serum interleukin (IL) 6 levels (pg/mL) by flow cytometry
Time frame: Baseline (week 0), time point 1 (week 4) and time point 2 (week 8)
Measurement of serum C-reactive protein (CRP) levels by flow cytometry
University of California, San Diego
Other
Acronym: KOMICS
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