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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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ClinicalTrials.gov Identifier: NCT02146157
Recruitment Status : Completed
First Posted : May 23, 2014
Last Update Posted : October 14, 2015
Sponsor:
Collaborator:
Procter and Gamble
Information provided by (Responsible Party):
NewChapter, Inc.

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.

Condition or disease Intervention/treatment Phase
Prediabetes Dietary Supplement: herb and mineral combination product Dietary Supplement: Placebo Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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 Start Date : February 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Arm Intervention/treatment
Active Comparator: 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.
Dietary Supplement: herb and mineral combination product
herb and mineral product containing cinnamon, turmeric and holy basil

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




Primary Outcome Measures :
  1. Change from Baseline in fasting blood glucose [ Time Frame: Day 84 ]
    Fasting glucose will be measured on serum samples obtained at screening (to be used as baseline value) and at day 84


Secondary Outcome Measures :
  1. Change from Baseline in fasting serum glucose [ Time Frame: Day 42 ]
    Fasting glucose will be measured on serum samples obtained at screening (to be used as baseline value) and at day 42

  2. Change from Baseline in fasting blood glucose [ Time Frame: Day 21 ]
    Fasting glucose will be measured on serum samples obtained at screening (to be used as baseline value) and at day 21

  3. Change from Baseline in HbA1c [ Time Frame: Day 84 ]
    Glycosylated hemoglobin (HbA1c) will be measured on whole blood samples obtained at screening and at day 84.

  4. Change from Baseline in fasting lipids [ Time Frame: Day 84 ]
    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.

  5. Change from Baseline in fasting lipids [ Time Frame: Day 42 ]
    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.

  6. Change from Baseline in fasting lipids [ Time Frame: Day 21 ]
    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.

  7. Change from Baseline in BMI [ Time Frame: Day 84 ]
    Body mass index

  8. Change from Baseline in waist-to-hip ratio [ Time Frame: Day 84 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02146157


Locations
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United States, Illinois
Radiant Research
Chicago, Illinois, United States, 60610
United States, Kentucky
Central Kentucky Research Associates
Lexington, Kentucky, United States, 40509
United States, Michigan
Quest Research Institute
Bingham Farms, Michigan, United States, 48025
United States, Ohio
Radiant Research
Cincinnati, Ohio, United States, 45249
Providence Health Partners Center for Clinical Research
Dayton, Ohio, United States, 45439
United States, South Carolina
Mountain View Clinical Research
Greer, South Carolina, United States, 29651
Sponsors and Collaborators
NewChapter, Inc.
Procter and Gamble

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Responsible Party: NewChapter, Inc.
ClinicalTrials.gov Identifier: NCT02146157     History of Changes
Other Study ID Numbers: 2012110
First Posted: May 23, 2014    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases