Blood Sugar Take Care and Glucose Metabolism

Prediabetes Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01554020
• Other study ID #: 120216-SUS-NWC-BSS-GP
• Status: Withdrawn
• Phase: Phase 2
• First received: March 7, 2012
• Last updated: March 11, 2013
• Start date: June 2012
• Est. completion date: November 2013

Study information

• Verified date: March 2013
• Source: NewChapter, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Prediabetes

Intervention

Dietary Supplement:
• Blood Sugar Take Care
One 1200 mg soft gel capsule administered 3X/day for duration of study
• Placebo
One 1200 mg soft-gel capsule administered 3X/day for duration of study

Locations

Country	Name	City	State
United States	SPRIM	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
NewChapter, Inc.	Sprim Advanced Life Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting glucose		12 weeks	No
Secondary	Insulin sensitivity index		12 weeks	No
Secondary	Fasting insulin		12 weeks	No
Secondary	Homeostasis Model Assessment of Insulin Resistance		12 weeks	No
Secondary	Quantitative insulin sensitivity check index		12 weeks	No
Secondary	Insulin secretion/insulin resistance index		12 weeks	No
Secondary	Glycosylated hemoglobin (HbA1c)		12 weeks	No
Secondary	High-sensitivity C-reactive protein		12 weeks	No
Secondary	High-molecular weight adiponectin		12 weeks	No
Secondary	Lipids (total cholesterol, HDL, LDL, VLDL, triglycerides)		12 weeks	No
Secondary	Body composition	height/weight, body mass index, waist circumference, hip circumference, waist-to-hip ratio	12 weeks	No
Secondary	WHO Quality of Life Questionnaire		12 weeks	No
Secondary	Comprehensive metabolic panel		12 weeks	Yes
Secondary	Complete blood count		12 weeks	Yes
Secondary	Adverse events		12 weeks	Yes
Secondary	Gastrointestinal Symptom Rating Scale		12 weeks	Yes
Secondary	Pulse		12 weeks	Yes
Secondary	Blood pressure		12 weeks	Yes