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

NCT ID: NCT02146157

Last Updated: 2015-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-06-30

Brief 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.

Conditions

Prediabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

herb and mineral combination product

Subjects will consume 3 herb and mineral combination product softgels daily, 1 softgel immediately before each of the 3 largest meals, throughout the 12-week supplementation period.

Group Type: ACTIVE_COMPARATOR

herb and mineral combination product

Intervention Type: DIETARY_SUPPLEMENT

herb and mineral product containing cinnamon, turmeric and holy basil

placebo

Subjects will consume 3 softgels daily, 1 softgel immediately before each of the 3 largest meals, throughout the 12-week supplementation period

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo of herb and mineral product containing cinnamon, turmeric and holy basil

Interventions

herb and mineral combination product

herb and mineral product containing cinnamon, turmeric and holy basil

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo of herb and mineral product containing cinnamon, turmeric and holy basil

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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
• History of alcohol, drug, or medication abuse
• Have participated in another study with any investigational product within 1 month of screening
• Had a recent (<3 months) gastrointestinal surgery or any planned surgery during the clinical study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: collaborator

NewChapter, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Other Identifiers

2012110

Identifier Type: -

Identifier Source: org_study_id