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RCT of a Polyherbal Dietary Supplement for Prediabetes

NCT03388762 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2022-06-28

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Alliance Institute for Integrative Medicine

    collaborator OTHER

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Chris D'Adamo, PhD · University of Maryland, Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-05
Primary Completion
2019-09-30
Completion
2020-01-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03388762 on ClinicalTrials.gov