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

Prediabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02146157
• Other study ID #: 2012110
• Status: Completed
• Phase: N/A
• First received: April 7, 2014
• Last updated: October 12, 2015
• Start date: February 2013
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: NewChapter, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Prediabetes

Intervention

Dietary Supplement:
• herb and mineral combination product
herb and mineral product containing cinnamon, turmeric and holy basil
• Placebo
Placebo of herb and mineral product containing cinnamon, turmeric and holy basil

Locations

Country	Name	City	State
United States	Quest Research Institute	Bingham Farms	Michigan
United States	Radiant Research	Chicago	Illinois
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	Central Kentucky Research Associates	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
NewChapter, Inc.	Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change from Baseline in fasting serum glucose	Fasting glucose will be measured on serum samples obtained at screening (to be used as baseline value) and at day 42	Day 42	No
Secondary	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 21	Day 21	No
Secondary	Change from Baseline in HbA1c	Glycosylated hemoglobin (HbA1c) will be measured on whole blood samples obtained at screening and at day 84.	Day 84	No
Secondary	Change from Baseline in fasting lipids	Total cholesterol, high-density lipoprotein, low-density lipoprotein, very low-density lipoprotein, and triglycerides will be measured on serum samples obtained at screening and at day 84 using a standard lipid panel.	Day 84	No
Secondary	Change from Baseline in fasting lipids	Total cholesterol, high-density lipoprotein, low-density lipoprotein, very low-density lipoprotein, and triglycerides will be measured on serum samples obtained at screening and at day 42 using a standard lipid panel.	Day 42	No
Secondary	Change from Baseline in fasting lipids	Total cholesterol, high-density lipoprotein, low-density lipoprotein, very low-density lipoprotein, and triglycerides will be measured on serum samples obtained at screening and at day 21 using a standard lipid panel.	Day 21	No
Secondary	Change from Baseline in BMI	Body mass index	Day 84	No
Secondary	Change from Baseline in waist-to-hip ratio		Day 84	No