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

NCT02146157 | Completed

• 1 other identifier: 2012110
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 6

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.

Conditions

Prediabetes

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in fasting blood glucose

  Fasting glucose will be measured on serum samples obtained at screening (to be used as baseline value) and at day 84

  Day 84

Secondary Outcomes (8)

• Change from Baseline in fasting serum glucose

  Day 42

• Change from Baseline in fasting blood glucose

  Day 21

• Change from Baseline in HbA1c

  Day 84

• Change from Baseline in fasting lipids

  Day 84

• Change from Baseline in fasting lipids

  Day 42

Study Arms (2)

herb and mineral combination product

ACTIVE COMPARATOR

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.

Dietary Supplement: herb and mineral combination product

placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

herb and mineral combination product DIETARY_SUPPLEMENT

herb and mineral product containing cinnamon, turmeric and holy basil

herb and mineral combination product

Placebo DIETARY_SUPPLEMENT

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

placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NewChapter, Inc.: lead
• Procter and Gamble: collaborator

Study Sites (6)

Radiant Research

Chicago, Illinois, 60610, United States

Location

Central Kentucky Research Associates

Lexington, Kentucky, 40509, United States

Location

Quest Research Institute

Bingham Farms, Michigan, 48025, United States

Location

Radiant Research

Cincinnati, Ohio, 45249, United States

Location

Providence Health Partners Center for Clinical Research

Dayton, Ohio, 45439, United States

Location

Mountain View Clinical Research

Greer, South Carolina, 29651, United States

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: May 23, 2014
• Study Start: February 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

US (6)