Blood Sugar Take Care and Glucose Metabolism

NCT ID: NCT01554020

Last Updated: 2013-03-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-11-30

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.

Conditions

Prediabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Multiherb product

Herbal product

Group Type: ACTIVE_COMPARATOR

Blood Sugar Take Care

Intervention Type: DIETARY_SUPPLEMENT

One 1200 mg soft gel capsule administered 3X/day for duration of study

Placebo

Maltodextrin control

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

One 1200 mg soft-gel capsule administered 3X/day for duration of study

Interventions

Blood Sugar Take Care

One 1200 mg soft gel capsule administered 3X/day for duration of study

Intervention Type: DIETARY_SUPPLEMENT

Placebo

One 1200 mg soft-gel capsule administered 3X/day for duration of study

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

BSTC

Eligibility Criteria

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
• 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. 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sprim Advanced Life Sciences

OTHER

Sponsor Role: collaborator

NewChapter, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Larry Miller, PhD

Role: PRINCIPAL_INVESTIGATOR

Sprim Advanced Life Sciences

Locations

SPRIM

San Francisco, California, United States

Countries

United States

Other Identifiers

120216-SUS-NWC-BSS-GP

Identifier Type: -

Identifier Source: org_study_id