RCT of a Polyherbal Dietary Supplement for Prediabetes
Completed · Not applicable · Has a placebo group
Conditions studied: Prediabetic State
In brief
The primary purpose of this study is to evaluate the impact of a polyherbal dietary supplement (Designs for Health - GlucoSupreme™ Herbal) on markers of glycemic control and other structure/function outcomes among a sample of prediabetic adults. A 12-week randomized, double-blinded, placebo-controlled clinical trial will be conducted to achieve the purpose of this study. The research team hypothesizes that GlucoSupreme™ Herbal will improve a variety of validated markers of glycemic control that are commonly used in clinical practice more effectively than placebo.
Key facts
- Study ID
- NCT03388762
- Run by
- University of Maryland, Baltimore
- People needed
- 39
- Starts
- 2017-12-05
- Expected to finish
- 2020-01-01
- Last updated by the study team
- 2022-06-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age ≥ 18 years
- Prediabetic blood measurement (HbA1C) of 5.7-6.4% and/or fasting blood glucose of 100-125 mg/dl and/or 2-hour Oral Glucose Tolerance Test blood glucose value of 140 mg/dl-199 mg/dl1 2) taken within the last 12 weeks
- Agree to continue with current diet and refrain from taking any new nutritional or herbal supplements
- Able to understand and write English
- Voluntarily consent to the study and understand its nature and purpose including potential risks and side effects
You may not qualify if…
- Current daily use of any oral hypoglycemic medication or insulin injection
- Current daily use of any supplement containing the herbs in the study supplement
- Known allergies to any substance in the study supplement
- Current daily tobacco smoker
- Currently pregnant or planning to become pregnant in the next 12 weeks
- Any current or previous diagnosis of diabetes (Type 1 or Type 2)
- Myocardial infarction, vascular surgery, or stroke in the past year
Where it is running
- University of Maryland Center for Diabetes and Endocrinology — Baltimore, Maryland, United States
- University of Maryland Family Medicine Associates — Baltimore, Maryland, United States
- University of Maryland School of Medicine, Department of Family and Community Medicine, East Hall — Baltimore, Maryland, United States
- Alliance Integrative Medicine — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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