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

Primary Purpose

Prediabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
herb and mineral combination product
Placebo
Sponsored by
NewChapter, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Prediabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Radiant Research
  • Central Kentucky Research Associates
  • Quest Research Institute
  • Radiant Research
  • Providence Health Partners Center for Clinical Research
  • Mountain View Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

herb and mineral combination product

placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Change from Baseline in HbA1c
Glycosylated hemoglobin (HbA1c) will be measured on whole blood samples obtained at screening and at day 84.
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.
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.
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.
Change from Baseline in BMI
Body mass index
Change from Baseline in waist-to-hip ratio

Full Information

First Posted
April 7, 2014
Last Updated
October 12, 2015
Sponsor
NewChapter, Inc.
Collaborators
Procter and Gamble
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1. Study Identification

Unique Protocol Identification Number
NCT02146157
Brief Title
Trial of an Herb and Mineral Combination Product on Fasting Glucose in Adults at Risk for Developing Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NewChapter, Inc.
Collaborators
Procter and Gamble

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
herb and mineral combination product
Arm Type
Active Comparator
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will consume 3 softgels daily, 1 softgel immediately before each of the 3 largest meals, throughout the 12-week supplementation period
Intervention Type
Dietary Supplement
Intervention Name(s)
herb and mineral combination product
Intervention Description
herb and mineral product containing cinnamon, turmeric and holy basil
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo of herb and mineral product containing cinnamon, turmeric and holy basil
Primary Outcome Measure Information:
Title
Change from Baseline in fasting blood glucose
Description
Fasting glucose will be measured on serum samples obtained at screening (to be used as baseline value) and at day 84
Time Frame
Day 84
Secondary Outcome Measure Information:
Title
Change from Baseline in fasting serum glucose
Description
Fasting glucose will be measured on serum samples obtained at screening (to be used as baseline value) and at day 42
Time Frame
Day 42
Title
Change from Baseline in fasting blood glucose
Description
Fasting glucose will be measured on serum samples obtained at screening (to be used as baseline value) and at day 21
Time Frame
Day 21
Title
Change from Baseline in HbA1c
Description
Glycosylated hemoglobin (HbA1c) will be measured on whole blood samples obtained at screening and at day 84.
Time Frame
Day 84
Title
Change from Baseline in fasting lipids
Description
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.
Time Frame
Day 84
Title
Change from Baseline in fasting lipids
Description
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.
Time Frame
Day 42
Title
Change from Baseline in fasting lipids
Description
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.
Time Frame
Day 21
Title
Change from Baseline in BMI
Description
Body mass index
Time Frame
Day 84
Title
Change from Baseline in waist-to-hip ratio
Time Frame
Day 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Radiant Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Central Kentucky Research Associates
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Quest Research Institute
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Facility Name
Radiant Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Providence Health Partners Center for Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45439
Country
United States
Facility Name
Mountain View Clinical Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States

12. IPD Sharing Statement

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

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