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.

Study Overview

• Status: Withdrawn
• Conditions: Prediabetes
• Intervention / Treatment: Dietary supplement: Blood Sugar Take Care; Dietary supplement: Placebo

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94109
      • SPRIM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: BSTC
Placebo Comparator: Placebo; Maltodextrin control	Dietary supplement: Placebo; One 1200 mg soft-gel capsule administered 3X/day for duration of study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fasting glucose	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events		12 weeks
Blood pressure		12 weeks
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
Glycosylated hemoglobin (HbA1c)		12 weeks
High-sensitivity C-reactive protein		12 weeks
High-molecular weight adiponectin		12 weeks
Lipids (total cholesterol, HDL, LDL, VLDL, triglycerides)		12 weeks
Body composition	height/weight, body mass index, waist circumference, hip circumference, waist-to-hip ratio	12 weeks
WHO Quality of Life Questionnaire		12 weeks
Comprehensive metabolic panel		12 weeks
Complete blood count		12 weeks
Gastrointestinal Symptom Rating Scale		12 weeks
Pulse		12 weeks

Collaborators and Investigators

• Sponsor: NewChapter, Inc.
• Collaborators: Sprim Advanced Life Sciences
• Investigators: Principal Investigator: Larry Miller, PhD, Sprim Advanced Life Sciences

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): October 1, 2013
• Study Completion (Anticipated): November 1, 2013

Study Registration Dates

• First Submitted: March 7, 2012
• First Submitted That Met QC Criteria: March 13, 2012
• First Posted (Estimate): March 14, 2012

Study Record Updates

• Last Update Posted (Estimate): March 12, 2013
• Last Update Submitted That Met QC Criteria: March 11, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Insulin sensitivity; Blood glucose; Oral glucose tolerance
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: 120216-SUS-NWC-BSS-GP