Ignite Creation Date:
2024-05-06 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03388762
Status:
COMPLETED
Last Update Posted:
2022-06-28
First Post:
2017-12-23
Brief Title:
RCT of a Polyherbal Dietary Supplement for Prediabetes
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Randomized Placebo-controlled Clinical Trial of a Polyherbal Dietary Supplement GlucoSupreme Herbal on Markers of Glycemic Control Among Prediabetic Adults
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 structurefunction 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
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 11 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
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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None