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WITHDRAWNPHASE2

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

NCT01554020•NewChapter, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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
+10 more criteria

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
+3 more criteria

Locations (1)

SPRIM

San Francisco, California, United States

Key Dates

Start Date

June 1, 2012

Primary Completion Date

October 1, 2013

Completion Date

November 1, 2013

Last Updated

March 12, 2013

Conditions

Prediabetes

Interventions

Blood Sugar Take Care

DIETARY_SUPPLEMENT

Placebo

DIETARY_SUPPLEMENT

Pharmacogenetics of the Response to GLP-1 in Mexican-Americans With Prediabetes

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PreDiabetes

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RECRUITINGNA

Rural Alliance for Diabetes Prevention

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PreDiabetes

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Food Insecurities

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Blood Sugar Take Care and Glucose Metabolism

Inclusion Criteria

Exclusion Criteria

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Rural Alliance for Diabetes Prevention

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