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

• ClinicalTrials.gov Identifier: NCT04107207
• Recruitment Status: Completed
• First Posted: September 27, 2019
• Last Update Posted: July 30, 2020
• Sponsor: Georgetown University
• Information provided by (Responsible Party): Georgetown University

Tracking Information

• First Submitted Date: September 1, 2019
• First Posted Date: September 27, 2019
• Last Update Posted Date: July 30, 2020
• Actual Study Start Date: November 11, 2019
• Actual Primary Completion Date: May 20, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 25, 2019)

Blood Sugar Levels [ Time Frame: 10 weeks ]

outcome measure: mg/dL

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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 (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: Evaluating the Effects of Kombucha as a Hyperglycemic Therapeutic Agent Within Diabetic Human Subjects
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Double blind crossover

Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

• Condition: Diabetes Mellitus

Intervention

• Dietary Supplement: Ginger Kombucha
  Craft Ginger Kombucha, a fermented black tea
• Dietary Supplement: Ginger Water
  Placebo

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 28, 2020): 12
• Original Estimated Enrollment (submitted: September 25, 2019): 30
• Actual Study Completion Date: July 1, 2020
• Actual Primary Completion Date: May 20, 2020 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04107207
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Current Responsible Party: Georgetown University
• Original Responsible Party: Same as current
• Current Study Sponsor: Georgetown University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Georgetown University
• Verification Date: July 2020