The Effect of Kombucha on Blood Sugar Levels in Humans
Primary Purpose
Glucose, Glucose Metabolism Disorders (Including Diabetes Mellitus), Blood Sugar; High
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Commercial kombucha tea
Brewed kombucha tea
Control: Tea
Control: Water
Sponsored by
About this trial
This is an interventional other trial for Glucose focused on measuring kombucha, kombucha tea, tea, fermented food
Eligibility Criteria
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.
Sites / Locations
- University of Missouri
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
Intervention group 1: commercial kombucha
Intervention group 2: brewed kombucha
Control group 1: tea
Control group 2: water
Arm Description
8oz
8oz
8oz
8oz
Outcomes
Primary Outcome Measures
Fasting blood glucose level
Blood drawn following a 10-12 hour fast.
Fasting insulin level.
Blood drawn following a 10-12 hour fast.
Blood glucose level
Oral glucose tolerance test
Insulin level
Oral glucose tolerance test
Secondary Outcome Measures
Blood pressure
Full Information
NCT ID
NCT04051294
First Posted
August 7, 2019
Last Updated
September 6, 2023
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT04051294
Brief Title
The Effect of Kombucha on Blood Sugar Levels in Humans
Official Title
A Clinical Trial to Measure the Biochemical Response of Kombucha Tea in Humans
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 3, 2019 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose, Glucose Metabolism Disorders (Including Diabetes Mellitus), Blood Sugar; High
Keywords
kombucha, kombucha tea, tea, fermented food
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group 1: commercial kombucha
Arm Type
Experimental
Arm Description
8oz
Arm Title
Intervention group 2: brewed kombucha
Arm Type
Experimental
Arm Description
8oz
Arm Title
Control group 1: tea
Arm Type
Active Comparator
Arm Description
8oz
Arm Title
Control group 2: water
Arm Type
Placebo Comparator
Arm Description
8oz
Intervention Type
Dietary Supplement
Intervention Name(s)
Commercial kombucha tea
Intervention Description
Commercially-available kombucha tea.
Intervention Type
Dietary Supplement
Intervention Name(s)
Brewed kombucha tea
Intervention Description
Kombucha tea brewed
Intervention Type
Other
Intervention Name(s)
Control: Tea
Intervention Description
Tea brewed in our lab.
Intervention Type
Other
Intervention Name(s)
Control: Water
Intervention Description
Tap water
Primary Outcome Measure Information:
Title
Fasting blood glucose level
Description
Blood drawn following a 10-12 hour fast.
Time Frame
Baseline
Title
Fasting insulin level.
Description
Blood drawn following a 10-12 hour fast.
Time Frame
Baseline
Title
Blood glucose level
Description
Oral glucose tolerance test
Time Frame
3 hour
Title
Insulin level
Description
Oral glucose tolerance test
Time Frame
3 hour
Secondary Outcome Measure Information:
Title
Blood pressure
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie M Kapp, MPH, PhD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of Kombucha on Blood Sugar Levels in Humans
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