Glucose, Glucose Metabolism Disorders (Including Diabetes Mellitus), Blood Sugar; High
Conditions
Keywords
kombucha, kombucha tea, tea, fermented food
Brief summary
As a phase 0 clinical trial, we will learn how kombucha influences glucose metabolism in humans.
Detailed description
Consumption of kombucha, a fermented tea beverage, has been promoted for a wide range of health benefits. However, a systematic literature review (Kapp & Sumner, 2019) revealed a lack of evidence for human health benefit. Despite the lack of evidence, U.S. retail sales of kombucha and other fermented beverages have increased 37.4% in 2017, and kombucha is the fastest growing product in the functional beverage market. As a phase 0 clinical trial, we will learn how kombucha influences glucose metabolism in humans. We plan for 20 subjects to take part in this study. This is a randomized-controlled counter-balanced study design. Subjects will be asked to complete 4 in-person visits over 2 months time (twice per month). At the first visit, subjects will be randomized into one of four groups. At each subsequent visit, subjects will be randomized into one of the remaining groups until they have completed each arm. Arms (at least 5 subjects in each arm, minimum total=20 subjects) 1. Intervention group 1: commercial kombucha: drink 8oz kombucha 2. Intervention group 2: brewed kombucha: drink 8oz kombucha 3. Control group: drink 8oz tea (the same type as used to brew the kombucha) 4. Control group 2: drink 8oz tap water
Interventions
DIETARY_SUPPLEMENTCommercial kombucha tea
Commercially-available kombucha tea.
DIETARY_SUPPLEMENTBrewed kombucha tea
Kombucha tea brewed
OTHERControl: Tea
Tea brewed in our lab.
OTHERControl: Water
Tap water
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Men or women ages 30-65 years old * English-speaking * Have transportation to campus * Overweight (BMI \>= 25 kg/m2) or obese (BMI \>=30 kg/m2)
Exclusion criteria
* Currently use any type of nicotine product * A diagnosis of any of the following: * Diabetes (type 1 or 2) * Cancer * COPD * Chronic alcoholism * Peripheral vascular disease * Autoimmune disease * Chronic kidney disease * Pregnant or breastfeeding * Prescribed medication for insulin, glucose-lowering drugs, or steroids, such as prednisone * Have routinely taken prebiotic or probiotic supplements in the past 3 months * Have routinely consumed any of the following more than one time per week in the past month: kombucha, kefir, yogurt, kimchi, cottage cheese, raw apple cider vinegar (with the mother), sauerkraut, kvass.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting blood glucose level | Baseline | Blood drawn following a 10-12 hour fast. |
| Fasting insulin level. | Baseline | Blood drawn following a 10-12 hour fast. |
| Blood glucose level | 3 hour | Oral glucose tolerance test |
| Insulin level | 3 hour | Oral glucose tolerance test |
Secondary
| Measure | Time frame |
|---|---|
| Blood pressure | Baseline |
Countries
United States
Outcome results
None listed