Blood Sugar Take Care and Glucose Metabolism

Phase 2

Withdrawn

• Conditions: Prediabetes
• Interventions: Dietary Supplement: Blood Sugar Take Care; Dietary Supplement: Placebo

• Registration Number: NCT01554020
• Lead Sponsor: NewChapter, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-07
• Study First Submitted QC: 2012-03-13
• Study First Posted: 2012-03-14
• Study Start: 2012-06
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-11
• Last Update Posted: 2013-03-12
• Primary Completion: 2013-10
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiherb product	Blood Sugar Take Care	Herbal product
Placebo	Placebo	Maltodextrin control

Primary Outcome Measures

Name	Time	Method
Fasting glucose	12 weeks

Secondary Outcome Measures

Name	Time	Method
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	12 weeks	height/weight, body mass index, waist circumference, hip circumference, waist-to-hip ratio
WHO Quality of Life Questionnaire	12 weeks
Comprehensive metabolic panel	12 weeks
Complete blood count	12 weeks
Adverse events	12 weeks
Gastrointestinal Symptom Rating Scale	12 weeks
Pulse	12 weeks
Blood pressure	12 weeks

Trial Locations

Locations (1)

SPRIM; 🇺🇸 San Francisco, California, United States