The Effect of Kombucha on Blood Sugar Levels in Humans

A Clinical Trial to Measure the Biochemical Response of Kombucha Tea in Humans

Sponsors

Lead Sponsor: University of Missouri-Columbia

Source University of Missouri-Columbia
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

Overall Status Recruiting
Start Date 2019-01-03
Completion Date 2022-12-01
Primary Completion Date 2022-12-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Fasting blood glucose level Baseline
Fasting insulin level. Baseline
Blood glucose level 3 hour
Insulin level 3 hour
Secondary Outcome
Measure Time Frame
Blood pressure Baseline
Enrollment 20
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Commercial kombucha tea

Description: Commercially-available kombucha tea.

Arm Group Label: Intervention group 1: commercial kombucha

Intervention Type: Dietary Supplement

Intervention Name: Brewed kombucha tea

Description: Kombucha tea brewed

Arm Group Label: Intervention group 2: brewed kombucha

Intervention Type: Other

Intervention Name: Control: Tea

Description: Tea brewed in our lab.

Arm Group Label: Control group 1: tea

Intervention Type: Other

Intervention Name: Control: Water

Description: Tap water

Arm Group Label: Control group 2: water

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.

Gender:

All

Minimum Age:

30 Years

Maximum Age:

65 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Julie M Kapp, MPH, PhD Principal Investigator University of Missouri-Columbia
Overall Contact

Last Name: Julie M Kapp, MPH, PhD

Phone: 5738843684

Email: [email protected]

Location
Facility: Status: Contact: University of Missouri [email protected]
Location Countries

United States

Verification Date

2021-12-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Missouri-Columbia

Investigator Full Name: Julie Kapp

Investigator Title: Associate Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Intervention group 1: commercial kombucha

Type: Experimental

Description: 8oz

Label: Intervention group 2: brewed kombucha

Type: Experimental

Description: 8oz

Label: Control group 1: tea

Type: Active Comparator

Description: 8oz

Label: Control group 2: water

Type: Placebo Comparator

Description: 8oz

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Other

Masking: Single (Participant)

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Clinical Trials on Glucose

Clinical Trials on Commercial kombucha tea