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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.

Tracking Information
First Submitted Date  ICMJE April 7, 2014
First Posted Date  ICMJE May 23, 2014
Last Update Posted Date October 14, 2015
Study Start Date  ICMJE February 2013
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02146157 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2014)
  • 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
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • Change from Baseline in BMI [ Time Frame: Day 84 ]
    Body mass index
  • Change from Baseline in waist-to-hip ratio [ Time Frame: Day 84 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of an Herb and Mineral Combination Product on Fasting Glucose in Adults at Risk for Developing Diabetes
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Prediabetes
Intervention  ICMJE
  • Dietary Supplement: herb and mineral combination product
    herb and mineral product containing cinnamon, turmeric and holy basil
  • Dietary Supplement: Placebo
    Placebo of herb and mineral product containing cinnamon, turmeric and holy basil
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: herb and mineral combination product
  • 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
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2014)
104
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02146157
Other Study ID Numbers  ICMJE 2012110
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NewChapter, Inc.
Study Sponsor  ICMJE NewChapter, Inc.
Collaborators  ICMJE Procter and Gamble
Investigators  ICMJE Not Provided
PRS Account NewChapter, Inc.
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP