- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04051294
The Effect of Kombucha on Blood Sugar Levels in Humans
A Clinical Trial to Measure the Biochemical Response of Kombucha Tea in Humans
Study Overview
Status
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)
- Intervention group 1: commercial kombucha: drink 8oz kombucha
- Intervention group 2: brewed 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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Julie M Kapp, MPH, PhD
- Phone Number: 5738843684
- Email: [email protected]
Study Locations
-
United States
-
Missouri
-
Columbia, Missouri, United States, 65212
- Recruiting
- University of Missouri
-
Contact:
- Email: [email protected]
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group 1: commercial kombucha
8oz
|
Commercially-available kombucha tea.
|
Experimental: Intervention group 2: brewed kombucha
8oz
|
Kombucha tea brewed
|
Active Comparator: Control group 1: tea
8oz
|
Tea brewed in our lab.
|
Placebo Comparator: Control group 2: water
8oz
|
Tap water
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasting blood glucose level
Time Frame: Baseline
|
Blood drawn following a 10-12 hour fast.
|
Baseline
|
Fasting insulin level.
Time Frame: Baseline
|
Blood drawn following a 10-12 hour fast.
|
Baseline
|
Blood glucose level
Time Frame: 3 hour
|
Oral glucose tolerance test
|
3 hour
|
Insulin level
Time Frame: 3 hour
|
Oral glucose tolerance test
|
3 hour
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood pressure
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julie M Kapp, MPH, PhD, University of Missouri-Columbia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014707
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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