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Blood Sugar Take Care and Glucose Metabolism

This study has been withdrawn prior to enrollment.
(Change of CRO)
Sponsor:
Collaborator:
Sprim Advanced Life Sciences
Information provided by (Responsible Party):
NewChapter, Inc.
ClinicalTrials.gov Identifier:
NCT01554020
First received: March 7, 2012
Last updated: March 11, 2013
Last verified: March 2013

March 7, 2012
March 11, 2013
June 2012
October 2013   (final data collection date for primary outcome measure)
Fasting glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Insulin sensitivity [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Insulin sensitivity glycemic index [ISI (gly) calculated with glucose and insulin measures during a 2-hr OGTT]
Complete list of historical versions of study NCT01554020 on ClinicalTrials.gov Archive Site
  • Insulin sensitivity index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Fasting insulin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Homeostasis Model Assessment of Insulin Resistance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Quantitative insulin sensitivity check index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Insulin secretion/insulin resistance index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Glycosylated hemoglobin (HbA1c) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • High-sensitivity C-reactive protein [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • High-molecular weight adiponectin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Lipids (total cholesterol, HDL, LDL, VLDL, triglycerides) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Body composition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    height/weight, body mass index, waist circumference, hip circumference, waist-to-hip ratio
  • WHO Quality of Life Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Comprehensive metabolic panel [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Complete blood count [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Gastrointestinal Symptom Rating Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Pulse [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Blood pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
HbA1c [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
HbA1c dtermination
Not Provided
Not Provided
 
Blood Sugar Take Care and Glucose Metabolism
Effect of Blood Sugar Take Care on Glucose Metabolism, Determinants of Metabolic Syndrome, and Quality of Life in Prediabetic Adults: A Randomized, Double-blind, Placebo-controlled Study

This prospective international clinical trial is a two-arm, double-blind, randomized, placebo-controlled, parallel-group, multicenter study. 112 prediabetic subjects will be randomized to Blood Sugar Take Care or placebo. Randomization will be stratified by gender. The intervention period is 12 weeks. The primary outcome is fasting glucose levels.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Prediabetes
  • Dietary Supplement: Blood Sugar Take Care
    One 1200 mg soft gel capsule administered 3X/day for duration of study
    Other Name: BSTC
  • Dietary Supplement: Placebo
    One 1200 mg soft-gel capsule administered 3X/day for duration of study
    Other Name: Placebo
  • Active Comparator: Multiherb product
    Herbal product
    Intervention: Dietary Supplement: Blood Sugar Take Care
  • Placebo Comparator: Placebo
    Maltodextrin control
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
November 2013
October 2013   (final data collection date for primary outcome measure)

SUBJECT INCLUSION CRITERIA: STEP 1

  1. Age ≥ 18 years
  2. Subject meets American Diabetes Association criteria for diabetes testing in asymptomatic, undiagnosed individuals:

    1. If age ≥45 years, subject must have a body mass index ≥ 25 kg/m2 for United States and ≥ 24 kg/m2 for Indonesia
    2. If age <45 years, subject must have a body mass index ≥ 25 kg/m2 for United States and ≥ 24 kg/m2 for Indonesia AND present with at least one of the following risk factors:

      • Have a first-degree relative with diabetes
      • Habitually physically inactive
      • Race is African-American, Hispanic American, Native American, Asian American, or Pacific Islander
      • Have delivered a baby weighing >9 lb or have been diagnosed with gestational diabetes mellitus
      • Hypertensive (≥140/90)
      • Known HDL cholesterol level 35 mg/dl
      • Known triglyceride level ≥250 mg/dl
      • On previous testing, had impaired glucose tolerance or impaired fasting glucose
      • History of vascular disease
  3. Stable body weight (<5% change) in the last 3 months
  4. Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
  5. Able to understand the nature and purpose of the study including potential risks and side effects
  6. Willing to consent to study participation and to comply with study requirements

SUBJECT EXCLUSION CRITERIA

  1. Known diabetes (type I or II)
  2. Recent use (within 2 weeks of screening) of any dietary supplement including vitamin and mineral complexes; herbal supplements; fish oil; fiber supplements; or any herbal ingredient/product that significantly affects glucose or lipid metabolism
  3. Recent use (within 4 weeks of screening) of any prescription or OTC medication that significantly affects glucose or lipid metabolism, including but not limited to, sulfonylureas, meglitinides, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, DPP-4 inhibitors, systemic corticosteroids, statins, fibrates, niacin, and bile acid sequestrants
  4. Daily use of nonsteroidal anti-inflammatory drugs (NSAIDS); (daily baby aspirin use acceptable)
  5. Any comorbidity 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
  6. Anticipated changes in dietary patterns or physical activity levels during the study, including attempts at body weight reduction
  7. Eating disorder
  8. Polycystic ovary syndrome
  9. Known allergies to any substance in the study product
  10. Pregnant or breastfeeding women
  11. History of alcohol, drug, or medication abuse
  12. Participation in another study with any investigational product within 3 months of screening
  13. Recent (<3 months) gastrointestinal surgery or any planned surgery during the treatment period

SUBJECT INCLUSION CRITERIA: STEP 2

1. Fasting glucose between 95 and 130 mg/dl, based on portable glucometer reading

SUBJECT INCLUSION CRITERIA: STEP 3

  1. Impaired fasting glucose, based on the American Diabetes Association definition of fasting serum glucose between 100 and 125 mg/dl
  2. Impaired glucose tolerance, based on the American Diabetes Association definition of serum glucose between 140 and 199 mg/dl 2 hours after a 75 g glucose load
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01554020
120216-SUS-NWC-BSS-GP
No
NewChapter, Inc.
NewChapter, Inc.
Sprim Advanced Life Sciences
Principal Investigator: Larry Miller, PhD Sprim Advanced Life Sciences
NewChapter, Inc.
March 2013

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