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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04107207
• Other study ID #: STUDY00001101
• Status: Completed
• Phase: N/A
• Start date: November 11, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2020
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 1, 2020
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United States	Georgetown University MedStar Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Sugar Levels	outcome measure: mg/dL	10 weeks
Secondary	Gut health	Worst ever | worse than usual | average | better than usual | best ever	10 weeks
Secondary	anxiety	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
Secondary	depression	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
Secondary	skin health	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
Secondary	vulvovaginal health	9.1. How would you rate your overall vulvovaginal health? Worst ever | worse than usual | average | better than usual | best ever	10 weeks