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Trial of an Herb and Mineral Combination Product on Fasting Glucose in Adults at Risk for Developing Diabetes | Clinical Trials | Clareo Health

COMPLETEDNA

Trial of an Herb and Mineral Combination Product on Fasting Glucose in Adults at Risk for Developing Diabetes

A Randomized, Double-blind, Placebo-controlled Trial to Assess Efficacy and Tolerability of an Herb and Mineral Combination Product on Fasting Glucose in Adults at Risk for Developing Diabetes

NCT02146157•NewChapter, Inc.

View on ClinicalTrials.gov

Summary

This is a multi-center, randomized, double-blind, placebo-controlled study in approximately 104 subjects (52 per group) to evaluate the effectiveness of an herb and mineral combination product on fasting serum glucose levels in subjects with impaired fasting glucose. The study consists of 5 visits: a Screening visit, followed by a Baseline visit (at which eligible subjects will be randomized to product to consume throughout the 12-week supplementation period), followed by Supplementation period visits at 3, 6 and 12 weeks after baseline.

Detailed Description

The target population of this clinical trial is otherwise healthy, pre-diabetic adults who present with impaired fasting glucose.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Be male or female, at least 18 years of age
•If age ≥45 years, must have a body mass index ≥ 25 kg/m2
•If age \<45 years, must have a body mass index ≥ 25 kg/m2 AND present with at least one additional risk factors for developing diabetes.
•Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (women only)
•Be able to understand the nature and purpose of the study including potential risks and side effects
•Be willing to consent to study participation and to comply with study requirements
•Have a finger stick fasting blood glucose between 105 and 140 mg/dL and a serum fasting glucose between 100 and 125 mg/dL, measured at screening

Exclusion Criteria

•Have diabetes (type I or II) or an HBA1c measurement \>6.5% at any time in the past or at the screening visit
•Have been taking within 2 weeks of screening any dietary supplement including vitamin and mineral complexes; herbal supplements; fish oil; fiber supplements; or any herbal ingredient/product that significantly affects glucose metabolism
•Have been taking within 4 weeks of screening any prescription or over-the-counter (OTC) medication that significantly affects glucose metabolism, including but not limited to, sulfonylureas, meglitinides, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, Inhibitors of dipeptidyl peptidase 4 (DPP-4 inhibitors), systemic corticosteroids
•Daily use of non-steroidal anti-inflammatory drugs (NSAIDS) (daily baby aspirin use and continuous use of NSAIDS for 3 days or less for acute aches and pains are acceptable)
•Any co-morbidity or treatment that could, in the opinion of the investigator, preclude the subject's ability to successfully and safely complete the study or that may confound study outcomes
•Anticipated changes in dietary patterns or physical activity levels during the study, including attempts at body weight reduction
•Eating disorder
•Polycystic ovary syndrome
•Known allergies or intolerance to any substance in the study product
•Are pregnant or breastfeeding women
+3 more criteria

Locations (6)

Radiant Research

Chicago, Illinois, United States

Central Kentucky Research Associates

Lexington, Kentucky, United States

Quest Research Institute

Bingham Farms, Michigan, United States

Radiant Research

Cincinnati, Ohio, United States

Providence Health Partners Center for Clinical Research

Dayton, Ohio, United States

Mountain View Clinical Research

Greer, South Carolina, United States

Key Dates

Start Date

February 1, 2013

Primary Completion Date

June 1, 2015

Completion Date

June 1, 2015

Last Updated

October 14, 2015

Enrollment

104

ACTUAL participants

Conditions

Prediabetes

Interventions

herb and mineral combination product

DIETARY_SUPPLEMENT

Placebo

DIETARY_SUPPLEMENT

Pharmacogenetics of the Response to GLP-1 in Mexican-Americans With Prediabetes

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PreDiabetes

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PreDiabetes

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 14, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Trial of an Herb and Mineral Combination Product on Fasting Glucose in Adults at Risk for Developing Diabetes

Inclusion Criteria

Exclusion Criteria

Pharmacogenetics of the Response to GLP-1 in Mexican-Americans With Prediabetes

Rural Alliance for Diabetes Prevention

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