Blood Sugar Take Care and Glucose Metabolism

NCT01554020 | Withdrawn Phase 2

• 1 other identifier: 120216-SUS-NWC-BSS-GP
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Blood glucose; Insulin sensitivity; Oral glucose tolerance

Outcome Measures

Primary Outcomes (1)

• Fasting glucose

  12 weeks

Secondary Outcomes (17)

• Insulin sensitivity index

  12 weeks

• Fasting insulin

  12 weeks

• Homeostasis Model Assessment of Insulin Resistance

  12 weeks

• Quantitative insulin sensitivity check index

  12 weeks

• Insulin secretion/insulin resistance index

  12 weeks

Study Arms (2)

Multiherb product

ACTIVE COMPARATOR

Herbal product

Dietary Supplement: Blood Sugar Take Care

Placebo

PLACEBO COMPARATOR

Maltodextrin control

Dietary Supplement: Placebo

Interventions

Blood Sugar Take Care DIETARY_SUPPLEMENT

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

Also known as: BSTC

Multiherb product

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Subject meets American Diabetes Association criteria for diabetes testing in asymptomatic, undiagnosed individuals:
• If age ≥45 years, subject must have a body mass index ≥ 25 kg/m2 for United States and ≥ 24 kg/m2 for Indonesia
• 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
• Stable body weight (\<5% change) in the last 3 months
• Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)

You may not qualify if:

• Known diabetes (type I or II)
• 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
• 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
• Daily use of nonsteroidal anti-inflammatory drugs (NSAIDS); (daily baby aspirin use acceptable)
• 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
• 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 to any substance in the study product
• Pregnant or breastfeeding women
• History of alcohol, drug, or medication abuse
• Participation in another study with any investigational product within 3 months of screening
• Recent (\<3 months) gastrointestinal surgery or any planned surgery during the treatment period
• \. Fasting glucose between 95 and 130 mg/dl, based on portable glucometer reading
• Impaired fasting glucose, based on the American Diabetes Association definition of fasting serum glucose between 100 and 125 mg/dl

Sponsors & Collaborators

• NewChapter, Inc.: lead
• Sprim Advanced Life Sciences: collaborator

Study Sites (1)

SPRIM

San Francisco, California, 94109, United States

Location

MeSH Terms

Conditions

Prediabetic State; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Larry Miller, PhD

  Sprim Advanced Life Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2012
• First Posted: March 14, 2012
• Study Start: June 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: March 12, 2013

Record last verified: 2013-03

Locations

US (1)