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Blood Sugar Take Care and Glucose Metabolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01554020
Recruitment Status : Withdrawn (Change of CRO)
First Posted : March 14, 2012
Last Update Posted : March 12, 2013
Sprim Advanced Life Sciences
Information provided by (Responsible Party):
NewChapter, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prediabetes Dietary Supplement: Blood Sugar Take Care Dietary Supplement: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : June 2012
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Multiherb product
Herbal product
Dietary Supplement: Blood Sugar Take Care
One 1200 mg soft gel capsule administered 3X/day for duration of study
Other Name: BSTC

Placebo Comparator: Placebo
Maltodextrin control
Dietary Supplement: Placebo
One 1200 mg soft-gel capsule administered 3X/day for duration of study

Primary Outcome Measures :
  1. Fasting glucose [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Insulin sensitivity index [ Time Frame: 12 weeks ]
  2. Fasting insulin [ Time Frame: 12 weeks ]
  3. Homeostasis Model Assessment of Insulin Resistance [ Time Frame: 12 weeks ]
  4. Quantitative insulin sensitivity check index [ Time Frame: 12 weeks ]
  5. Insulin secretion/insulin resistance index [ Time Frame: 12 weeks ]
  6. Glycosylated hemoglobin (HbA1c) [ Time Frame: 12 weeks ]
  7. High-sensitivity C-reactive protein [ Time Frame: 12 weeks ]
  8. High-molecular weight adiponectin [ Time Frame: 12 weeks ]
  9. Lipids (total cholesterol, HDL, LDL, VLDL, triglycerides) [ Time Frame: 12 weeks ]
  10. Body composition [ Time Frame: 12 weeks ]
    height/weight, body mass index, waist circumference, hip circumference, waist-to-hip ratio

  11. WHO Quality of Life Questionnaire [ Time Frame: 12 weeks ]
  12. Comprehensive metabolic panel [ Time Frame: 12 weeks ]
  13. Complete blood count [ Time Frame: 12 weeks ]
  14. Adverse events [ Time Frame: 12 weeks ]
  15. Gastrointestinal Symptom Rating Scale [ Time Frame: 12 weeks ]
  16. Pulse [ Time Frame: 12 weeks ]
  17. Blood pressure [ Time Frame: 12 weeks ]

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


  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


  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


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


  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

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 identifier (NCT number): NCT01554020

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United States, California
San Francisco, California, United States, 94109
Sponsors and Collaborators
NewChapter, Inc.
Sprim Advanced Life Sciences
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Principal Investigator: Larry Miller, PhD Sprim Advanced Life Sciences

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Responsible Party: NewChapter, Inc. Identifier: NCT01554020     History of Changes
Other Study ID Numbers: 120216-SUS-NWC-BSS-GP
First Posted: March 14, 2012    Key Record Dates
Last Update Posted: March 12, 2013
Last Verified: March 2013
Keywords provided by NewChapter, Inc.:
Blood glucose
Insulin sensitivity
Oral glucose tolerance
Additional relevant MeSH terms:
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Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases