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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Dietary Supplement: Ginger Water; Dietary Supplement: Ginger Kombucha

• Registration Number: NCT04107207
• Lead Sponsor: Georgetown University

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 available

Study Timeline

• Study First Submitted: 2019-09-01
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-27
• Study Start: 2019-11-11
• Primary Completion: 2020-05-20
• Status Verified: 2020-07
• Study Completion: 2020-07-01
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Intervention	Ginger Water	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.
Kombucha Intervention	Ginger Kombucha	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.

Primary Outcome Measures

Name	Time	Method
Blood Sugar Levels	10 weeks	outcome measure: mg/dL

Secondary Outcome Measures

Name	Time	Method
Gut health	10 weeks	Worst ever \| worse than usual \| average \| better than usual \| best ever
anxiety	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	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	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	10 weeks	9.1. How would you rate your overall vulvovaginal health? Worst ever \| worse than usual \| average \| better than usual \| best ever

Trial Locations

Locations (1)

Georgetown University MedStar Hospital; 🇺🇸 Washington, District of Columbia, United States