RCT of a Polyherbal Dietary Supplement for Prediabetes

NCT03388762 | Completed

• 1 other identifier: 022-DFH, HP-00075768
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (8)

• Fasting Blood Glucose

  Elevated fasting blood glucose is one of the markers of the prediabetic state. According to American Diabetes Association criteria, the prediabetic fasting blood glucose range is 100 to 125 mg/dL (5.6 to 6.9 mmol/L). After fasting for 8-12 hours, \> 0.5mL of blood will be collected from each participant, followed by centrifuge separation of plasma from cells within 45 minutes of collection. After maintaining the plasma fasting blood glucose at room temperature, it will be analyzed using standard enzymatic methodology.

  Baseline and study end (12 weeks from baseline)

• Glycated hemoglobin/A1C (HbA1c)

  Elevated HbA1c is another one of the markers of the prediabetic state and is defined as being within the range of 5.7-6.4%. A four mL sample of whole blood will be obtained from participants using techniques described above, and placed in an EDTA, lithium heparin, or sodium fluoride tube, followed by analysis using the Roche Tina Quant (Roche, Germany).

  Baseline and study end (12 weeks from baseline)

• Fasting insulin

  In prediabetes, pancreatic beta cells can no longer produce enough insulin to overcome insulin resistance, which can cause blood glucose levels to rise above the normal range. Thus, fasting insulin is a glycemic parameter of interest and is also used to determine insulin resistance. While normal values for fasting insulin are \<25 microU/L, fasting insulin can vary widely among prediabetic individuals. After fasting for 8-12 hours, 0.8mL blood serum will be obtained from each participant. This fasting insulin assay will be performed using a 2-site electrochemiluminescent immunoassay on the Roche automated platform (Roche, Germany.).

  Baseline and study end (12 weeks from baseline)

• Insulin Resistance (HOMA-IR)

  Insulin resistance often sets the stage for progression to T2D by placing a high demand on insulin-producing beta cells during a prediabetic state. The advantage of using the validated HOMA-IR calculation is its relative simplicity and low-cost since it is derived from other primary outcomes of interest in this study. HOMA-IR is calculated as: \[Fasting insulin (microU/L) x Fasting Blood Glucose (nmol/L)\]/22.5.

  Baseline and study end (12 weeks from baseline)

• β-cell function (HOMA-β)

  Pancreatic beta cells (β-cells) produce insulin. Thus, their function is of interest in this prediabetic study population. As is the case with HOMA-IR, this formula utilizes values from our other study outcomes. HOMA- β is calculated as: (20 x Fasting insulin \[microU/L\])/(Fasting blood glucose \[mmol/l\] - 3.5).

  Baseline and study end (12 weeks from baseline)

• Quantitative Insulin Sensitivity Check Index (QUICKI)

  The validated QUICKI measurement to assess insulin sensitivity has also been studied in herbal dietary supplement clinical trials. QUICKI is calculated as: 1/(log-fasting blood glucose \[mg/dL\] + log-fasting insulin \[uU/mL\]).

  Baseline and study end (12 weeks from baseline)

• Fructosamine

  Many serum proteins are involved in glucose synthesis. Fructosamine represents the degree of glycation in these proteins, and is the concentration of plasma glucose over the lifetime of the protein. This useful test has been utilized in previous clinical studies of natural products3 4 and is an adjunct to the A1C and other fasting glycemic measurements, and reflects intermediate-term (previous 2-3 weeks) glycemic change. One mL of serum or plasma will be collected, followed by centrifuge separation within 45 minutes of collection, and analyzed using standard colorimetric assay methodology (LabCorp, Inc.).

  Baseline and study end (12 weeks from baseline)

• GlycoMark

  A blood test commonly used in clinical practice to determine peak hyperglycemia. The GlycoMark test provides accurate recognition of recent glycemic deterioration or improvement (within the previous 2-4 weeks)5 6 and is commonly given adjacently to A1C (a longer-term indicator of glycemic change) in clinical practice. One mL of serum or plasma will be collected, followed by centrifuge separation within 60 minutes of collection, and analyzed using standard enzymatic colorimetric assay methodology (LabCorp, Inc.).

  Baseline and study end (12 weeks from baseline)

Secondary Outcomes (4)

• Lipid profile

  Baseline and study end (12 weeks from baseline)

• Inflammation

  Baseline and study end (12 weeks from baseline)

• Supplement compliance assessed using participant daily diary

  Study end (12 weeks from baseline)

• Adverse events

  Throughout the study and at study end (12 weeks from baseline)

Study Arms (2)

GlucoSupreme™ Herbal

ACTIVE COMPARATOR

Each daily serving of four GlucoSupreme™ Herbal tablets includes extracts from: cinnamon bark (Cinnamomum cassia) 500 mg, banaba leaf (Lagerstroemia speciosa standardized to 1% corosolic acid) 200 mg, kudzu root (Pueraria lobata standardized to 40% isoflavones) 200 mg, fenugreek seed (Trigonella foenum-graceum standardized to contain 60% saponins) 200 mg, and gymnema leaf (Gymnema sylvestre standardized to contain 25% gymnemic acid). Additionally, American ginseng root (Panax quinquefolius standardized to contain 5% ginsenosides) 200 mg, and berberine HCl derived from bark (Berberis aristata) 500 mg. Other ingredients include Cellulose (capsule), microcrystalline cellulose, silicon dioxide, and vegetable stearate.

Dietary Supplement: GlucoSupreme™ Herbal

Control

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

GlucoSupreme™ Herbal DIETARY_SUPPLEMENT

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.

GlucoSupreme™ Herbal

Placebo OTHER

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Alliance Institute for Integrative Medicine: collaborator

Study Sites (4)

University of Maryland Center for Diabetes and Endocrinology

Baltimore, Maryland, 21201, United States

Location

University of Maryland Family Medicine Associates

Baltimore, Maryland, 21201, United States

Location

University of Maryland School of Medicine, Department of Family and Community Medicine, East Hall

Baltimore, Maryland, 21201, United States

Location

Alliance Integrative Medicine

Cincinnati, Ohio, 45236, United States

Location

Related Publications (1)

• 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.

  PMID: 30616613 DERIVED

MeSH Terms

Conditions

Prediabetic State; Hyperglycemia; Chronic Disease

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chris D'Adamo, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The study products will be delivered to the investigative sites prior to enrollment of subjects. A study code will be provided for every batch of study product shipped to the investigational site prior to the beginning of the study. The placebo utilized in this clinical trial will be formulated to be as similar as possible to the active in appearance, odor, and other key characteristics, and packaging for both intervention and placebo will be the same. The de-identified study product will be packaged and labeled according to the study code and participant identification numbers; the Study Coordinator will oversee a locked master list of these, in addition to batch numbers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Integrative Medicine

Model Details: 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.

Study Record Dates

• First Submitted: December 23, 2017
• First Posted: January 3, 2018
• Study Start: December 5, 2017
• Primary Completion: September 30, 2019
• Study Completion: January 1, 2020
• Last Updated: June 28, 2022

Record last verified: 2022-06

Locations

US (4)