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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 : Active, not recruiting
First Posted : September 27, 2019
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Georgetown University

Tracking Information
First Submitted Date  ICMJE September 1, 2019
First Posted Date  ICMJE September 27, 2019
Last Update Posted Date March 3, 2020
Actual Study Start Date  ICMJE November 11, 2019
Actual Primary Completion Date January 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2019)
Blood Sugar Levels [ Time Frame: 10 weeks ]
outcome measure: mg/dL
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2019)
  • Gut health [ Time Frame: 10 weeks ]
    Worst ever | worse than usual | average | better than usual | best ever
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2019)
  • Gut health [ Time Frame: 10 weeks ]
    outcome measure: qualitative questions regarding rating and symptoms
  • anxiety [ Time Frame: 10 weeks ]
    outcome measure: GAD7
  • depression [ Time Frame: 10 weeks ]
    outcome measure: PHQ-9
  • skin health [ Time Frame: 10 weeks ]
    outcome measure: qualitative questions/symptom occurence
  • vulvovaginal health [ Time Frame: 10 weeks ]
    outcome measure: qualitative rating/symptom occurence
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating the Effects of Kombucha as a Hyperglycemic Therapeutic Agent Within Diabetic Human Subjects
Official Title  ICMJE Pilot Study to Evaluate Effects of Kombucha as a Hyperglycemic Therapeutic Agent Within Diabetic Human Subjects
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Double blind crossover
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE
  • Dietary Supplement: Ginger Kombucha
    Craft Ginger Kombucha, a fermented black tea
  • Dietary Supplement: Ginger Water
    Placebo
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: Ginger Kombucha
  • 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.
    Intervention: Dietary Supplement: Ginger 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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 5, 2019)
17
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2019)
30
Estimated Study Completion Date  ICMJE May 1, 2020
Actual Primary Completion Date January 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04107207
Other Study ID Numbers  ICMJE STUDY00001101
Has Data Monitoring Committee Not Provided
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
Plan to Share IPD: Undecided
Responsible Party Georgetown University
Study Sponsor  ICMJE Georgetown University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Georgetown University
Verification Date September 2019

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