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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04107207
Recruitment Status : Completed
First Posted : September 27, 2019
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Georgetown University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Dietary Supplement: Ginger Kombucha Dietary Supplement: Ginger Water Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Double blind crossover
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pilot Study to Evaluate Effects of Kombucha as a Hyperglycemic Therapeutic Agent Within Diabetic Human Subjects
Actual Study Start Date : November 11, 2019
Actual Primary Completion Date : May 20, 2020
Actual Study Completion Date : July 1, 2020

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Blood Sugar Levels [ Time Frame: 10 weeks ]
    outcome measure: mg/dL


Secondary Outcome Measures :
  1. Gut health [ Time Frame: 10 weeks ]
    Worst ever | worse than usual | average | better than usual | best ever

  2. 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

  3. 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

  4. 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

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04107207


Locations
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United States, District of Columbia
Georgetown University MedStar Hospital
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
More Information
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Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT04107207    
Other Study ID Numbers: STUDY00001101
First Posted: September 27, 2019    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No