Clinical trial NCT03388762: RCT of a Polyherbal Dietary Supplement for Prediabetes
Official title: A Randomized, Placebo-controlled Clinical Trial of a Polyherbal Dietary Supplement (GlucoSupreme™ Herbal) on Markers of Glycemic Control Among Prediabetic Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetic State
Keywords: Hyperglycemia
Prediabetes
Botanical
Phytochemicals
Dietary Supplements
Berberine
Fenugreek
American Ginseng
Gymnema
Banaba
Kudzu
Cinnamon
Glycated hemoglobin
Trigonella
Blood Glucose
Panax
Plant Extracts
Public Health
Chronic Disease
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Alliance Institute for Integrative Medicine
First posted: 2018-01-03
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a 12-week, randomized, double-blinded, placebo-controlled clinical trial of GlucoSupreme™ Herbal. Eligible participants will be recruited from within participating clinical practices. All study outcomes will be biomarkers, capturing normal structure and function of the human body, derived from blood draws ordered during two physician visits spaced 12 weeks apart. This is a typical interval between blood assessments of glycemic control in routine clinical practice. 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. Serious adverse events, while not anticipated, will be reported by the participant to a study physician as soon as possible.
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. 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
3. Agree to continue with current diet and refrain from taking any new nutritional or herbal supplements
4. Able to understand and write English
5. Voluntarily consent to the study and understand its nature and purpose including potential risks and side effects

Exclusion Criteria:

1. Current daily use of any oral hypoglycemic medication or insulin injection
2. Current daily use of any supplement containing the herbs in the study supplement
3. Known allergies to any substance in the study supplement
4. Current daily tobacco smoker
5. Currently pregnant or planning to become pregnant in the next 12 weeks
6. Any current or previous diagnosis of diabetes (Type 1 or Type 2)
7. Myocardial infarction, vascular surgery, or stroke in the past year

Primary outcomes:
measure: Fasting Blood Glucose
timeFrame: Baseline and study end (12 weeks from baseline)
measure: Glycated hemoglobin/A1C (HbA1c)
timeFrame: Baseline and study end (12 weeks from baseline)
measure: Fasting insulin
timeFrame: Baseline and study end (12 weeks from baseline)
measure: Insulin Resistance (HOMA-IR)
timeFrame: Baseline and study end (12 weeks from baseline)
measure: β-cell function (HOMA-β)
timeFrame: Baseline and study end (12 weeks from baseline)
measure: Quantitative Insulin Sensitivity Check Index (QUICKI)
timeFrame: Baseline and study end (12 weeks from baseline)
measure: Fructosamine
timeFrame: Baseline and study end (12 weeks from baseline)
measure: GlycoMark
timeFrame: Baseline and study end (12 weeks from baseline)
Secondary outcomes:
measure: Lipid profile
timeFrame: Baseline and study end (12 weeks from baseline)
measure: Inflammation
timeFrame: Baseline and study end (12 weeks from baseline)
measure: Supplement compliance assessed using participant daily diary
timeFrame: Study end (12 weeks from baseline)
measure: Adverse events
timeFrame: Throughout the study and at study end (12 weeks from baseline)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Center for Diabetes and Endocrinology
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland Family Medicine Associates
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland School of Medicine, Department of Family and Community Medicine, East Hall
state: Maryland
city: Cincinnati
country: United States
facility: Alliance Integrative Medicine
state: Ohio
Study officials:
affiliation: University of Maryland, Baltimore
name: Chris D'Adamo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feinberg T, Wieland LS, Miller LE, Munir K, Pollin TI, Shuldiner AR, Amoils S, Gallagher L, Bahr-Robertson M, D'Adamo CR. Polyherbal dietary supplementation for prediabetic adults: study protocol for a randomized controlled trial. Trials. 2019 Jan 7;20(1):24. doi: 10.1186/s13063-018-3032-6.