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| Name | Class |
|---|---|
| GT's Living Foods | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jack A Gilbert, Ph.D. | UC San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego ACTRI | La Jolla | California | 92037 | United States |
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| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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) |