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Trial record 2 of 3 for:    kombucha

The Effect of Kombucha on Blood Sugar Levels in Humans

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ClinicalTrials.gov Identifier: NCT04051294
Recruitment Status : Recruiting
First Posted : August 9, 2019
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
Julie Kapp, University of Missouri-Columbia

Tracking Information
First Submitted Date  ICMJE August 7, 2019
First Posted Date  ICMJE August 9, 2019
Last Update Posted Date March 23, 2020
Actual Study Start Date  ICMJE January 3, 2019
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
Blood pressure [ Time Frame: Baseline ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Kombucha on Blood Sugar Levels in Humans
Official Title  ICMJE A Clinical Trial to Measure the Biochemical Response of Kombucha Tea in Humans
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE
  • Glucose
  • Glucose Metabolism Disorders (Including Diabetes Mellitus)
  • Blood Sugar; High
Intervention  ICMJE
  • Dietary Supplement: Commercial kombucha tea
    Commercially-available kombucha tea.
  • Dietary Supplement: Brewed kombucha tea
    Kombucha tea brewed
  • Other: Control: Tea
    Tea brewed in our lab.
  • Other: Control: Water
    Tap water
Study Arms  ICMJE
  • Experimental: Intervention group 1: commercial kombucha
    8oz
    Intervention: Dietary Supplement: Commercial kombucha tea
  • Experimental: Intervention group 2: brewed kombucha
    8oz
    Intervention: Dietary Supplement: Brewed kombucha tea
  • Active Comparator: Control group 1: tea
    8oz
    Intervention: Other: Control: Tea
  • Placebo Comparator: Control group 2: water
    8oz
    Intervention: Other: Control: Water
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 7, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Julie M Kapp, MPH, PhD 5738843684 kappj@health.missouri.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04051294
Other Study ID Numbers  ICMJE 2014707
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Julie Kapp, University of Missouri-Columbia
Study Sponsor  ICMJE University of Missouri-Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Julie M Kapp, MPH, PhD University of Missouri-Columbia
PRS Account University of Missouri-Columbia
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP