Evaluating the Effects of Kombucha as a Hyperglycemic Therapeutic Agent Within Diabetic Human Subjects

July 28, 2020 updated by: Georgetown University

Pilot Study to Evaluate Effects of Kombucha as a Hyperglycemic Therapeutic Agent Within Diabetic Human Subjects

This study's primary objective is to determine the ability of Kombucha to impact blood sugar levels in patients with diabetes mellitus type II. The secondary objective is to determine the ability of Kombucha to impact blood pressure, and quality of life measures as measured by uniform questionnaire that includes: gut health, colds, infections, headaches, sleep, anxiety (GAD2), depression (PHQ2), skin health.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University MedStar Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. S/he is above the age of 18
  2. S/he has the ability to read, speak and write English
  3. S/he has telephone access
  4. S/he is diabetic and willing to check blood sugar levels every day
  5. Hb A1c >7%
  6. Possesses a glucometer

Exclusion Criteria:

  1. Allergy to kombucha ingredients
  2. Drinks kombucha regularly (>3time per week)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Kombucha Intervention
Either ginger kombucha or placebo ginger water will be given to subjects for weeks 1-4 and then the reciprocal beverage for weeks 6-10.
Dietary supplement: Ginger Kombucha
Craft Ginger Kombucha, a fermented black tea
Placebo Comparator: Placebo Intervention
Either ginger kombucha or placebo ginger water will be given to subjects for weeks 1-4 and then the reciprocal beverage for weeks 6-10.
Dietary supplement: Ginger Water
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Sugar Levels
Time Frame: 10 weeks
outcome measure: mg/dL
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut health
Time Frame: 10 weeks
Worst ever | worse than usual | average | better than usual | best ever
10 weeks
anxiety
Time Frame: 10 weeks
How often have you been bothered by the following problems? 6.1. Feeling nervous, anxious or on edge Not at all | Several days | More than half the days | Nearly every day
10 weeks
depression
Time Frame: 10 weeks
How often have you been bothered by the following problems? 6.3. Little interest or pleasure in doing things Not at all | Several days | More than half the days | Nearly every day
10 weeks
skin health
Time Frame: 10 weeks
4.1. How would you rate your overall skin health? Worst ever | worse than usual | average | better than usual | best ever 5. How often do you experience skin problems such as dry skin, eczema, rashes, or acne? Not at all | Several days | More than half the days | Nearly every day
10 weeks
vulvovaginal health
Time Frame: 10 weeks
9.1. How would you rate your overall vulvovaginal health? Worst ever | worse than usual | average | better than usual | best ever
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2019

Primary Completion (Actual)

May 20, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

September 1, 2019

First Submitted That Met QC Criteria

September 25, 2019

First Posted (Actual)

September 27, 2019

Study Record Updates

Last Update Posted (Actual)

July 30, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00001101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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 register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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