The Effect of Kombucha on Blood Sugar Levels in Humans
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|ClinicalTrials.gov Identifier: NCT04051294|
Recruitment Status : Not yet recruiting
First Posted : August 9, 2019
Last Update Posted : August 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glucose Glucose Metabolism Disorders (Including Diabetes Mellitus) Blood Sugar; High||Dietary Supplement: Commercial kombucha tea Dietary Supplement: Lab-brewed kombucha tea Other: Control: Tea Other: Control: Water||Not Applicable|
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)
- Intervention group 1: commercial kombucha: drink 8oz kombucha
- Intervention group 2: lab brew kombucha: drink 8oz kombucha
- Control group: drink 8oz tea (the same type as used to brew the kombucha)
- Control group 2: drink 8oz tap water
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||A Clinical Trial to Measure the Biochemical Response of Kombucha Tea in Humans|
|Estimated Study Start Date :||August 2019|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Intervention group 1: commercial kombucha
Dietary Supplement: Commercial kombucha tea
Commercially-available kombucha tea.
Experimental: Intervention group 2: brewed kombucha
Dietary Supplement: Lab-brewed kombucha tea
Kombucha tea brewed in our lab.
Active Comparator: Control group 1: tea
Other: Control: Tea
Tea brewed in our lab.
Placebo Comparator: Control group 2: water
Other: Control: Water
- Fasting blood glucose level [ Time Frame: Baseline ]Blood drawn following a 10-12 hour fast.
- Fasting insulin level. [ Time Frame: Baseline ]Blood drawn following a 10-12 hour fast.
- Blood glucose level [ Time Frame: 3 hour ]Oral glucose tolerance test
- Insulin level [ Time Frame: 3 hour ]Oral glucose tolerance test
- Blood pressure [ Time Frame: Baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04051294
|Contact: Julie M Kapp, MPH, PhDfirstname.lastname@example.org|
|Principal Investigator:||Julie M Kapp, MPH, PhD||University of Missouri-Columbia|