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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Ginger Kombucha
* Dietary Supplement: Ginger Water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: S/he is above the age of 18 S/he has the ability to read, speak and write English S/he has telephone access S/he is diabetic and willing to check blood sugar levels every day Hb A1c >7% Possesses a glucometer Exclusion Criteria: Allergy to kombucha ingredients Drinks kombucha regularly (>3time per week)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Double blind crossover
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Kombucha Intervention<br>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<br>* Craft Ginger Kombucha, a fermented black tea<br>|
| Placebo Comparator: Placebo Intervention<br>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<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Sugar Levels | outcome measure: mg/dL | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut health | Worst ever | worse than usual | average | better than usual | best ever | 10 weeks | 
| 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 | 
| 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 | 
| 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 | 
| 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 |