NCT03388762

RCT of a Polyherbal Dietary Supplement for Prediabetes

A Randomized, Placebo-controlled Clinical Trial of a Polyherbal Dietary Supplement (GlucoSupreme™ Herbal) on Markers of Glycemic Control Among Prediabetic Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Prediabetes is a common state in which blood glucose levels are elevated, but are not elevated high enough to be considered Type 2 Diabetes (T2D). The worldwide prevalence of prediabetes is high and rapidly increasing. People with prediabetes are at increased risk for developing a variety of chronic diseases. Most notably, prediabetes nearly always precedes diagnosis of T2D, a poorly-controlled disease adversely affecting 14% of adults in the United States. T2D is responsible for increased risk of heart disease, stroke, blindness and other vision problems, kidney disease, amputations and death. Prediabetes often progresses to T2D relatively quickly, as pancreatic beta-cell dysfunction perpetuates. There are currently limited pharmacological options available for safely reducing the burden of prediabetes. Furthermore, these pharmacological options often carry potentially deleterious side effects. Low-risk alternatives are needed where lifestyle modifications, such as increased physical activity and weight loss, have failed. Herbal dietary supplements have shown promise in safely managing impaired glycemic control in prediabetic adults in many clinical studies. A wide variety of herbs have been previously studied for these purposes, including cinnamon, fenugreek, banaba, curcumin, and a variety of combination products. Of these, most have demonstrated improved management of glycemic control, particularly with regard to reducing fasting blood glucose and postprandial glucose, HbA1c, fasting insulin levels, HOMA-Insulin Resistance, and increasing HOMA-β cell function among prediabetic adult populations. Many herbs have also demonstrated benefit in the management of glycemic control in clinical trials among T2D populations. These herbs include berberine, ginseng, gymnema, banaba, cinnamon, fenugreek, and kudzu, all of which are present in GlucoSupreme™ Herbal. The research team hypothesizes that GlucoSupreme™ Herbal will demonstrate superior improvements in markers of glycemic control than placebo over twelve weeks of daily supplementation among a sample of healthy adults. The research team aims to conduct a randomized, placebo-controlled, double-blinded clinical trial to evaluate this hypothesis among a diverse sample of 40 prediabetic adults, and will implement a 1:1 study allocation ratio. This study will utilize an adaptive sample size re-estimation (SSR) approach where participant enrollment may be extended beyond the originally planned sample size if interim effect size is smaller than anticipated, but still promising, thereby preserving study power; this will be determined by examination of available unblinded endpoint data by an independent statistician after 30 subjects are enrolled.

Conditions

• Prediabetic State

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	GlucoSupreme™ Herbal	This study will assess changes in glycemic parameters and other biomarkers over a twelve week period, with two blood draws (Baseline and 12 weeks). Additionally, an IRB-approved research associate will call each study participant at the 6-week mid-point of the study to assess compliance and collect data on any adverse events.
OTHER	Placebo	The placebo utilized in this clinical trial will be formulated by the manufacturer to be as similar as possible to the active intervention in appearance, odor, and other key characteristics. Packaging for the control will be identical to packaging for the Active Comparator.

Timeline

• Start date: 2017-12-05
• Primary completion: 2019-09-30
• Completion: 2020-01-01
• First posted: 2018-01-03
• Last updated: 2022-06-28

Locations

4 sites across 1 country: United States