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Effects of Novel Fiber on Glucose Metabolism and Insulin Sensitivity

NCT01375803 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2011-06-17

No results posted yet for this study

Summary

This study will critically evaluate the effects of a novel dietary fiber administered to subjects at high risk for developing diabetes to determine if this intervention will improve insulin sensitivity compared to control product administration and, thus, decrease risk for developing diabetes.

The hypothesis is that consuming this novel fiber twice a day for 12 weeks will significantly decrease fasting plasma glucose, insulin and glycosylated hemoglobin values in pre-diabetic subjects (i.e. subjects with fasting plasma glucose levels 95-140 mg/dl at screening) compared to consumption of the control product.

Conditions

Interventions

DIETARY_SUPPLEMENT

Novel dietary fiber

oral consumption in beverage

DIETARY_SUPPLEMENT

Novel dietary fiber

Oral consumption in beverage

OTHER

Placebo

Oral consumption in beverage

Sponsors & Collaborators

  • Cargill

    lead INDUSTRY

Principal Investigators

  • Harold E Bays, MD, FACP · Louisville Metabolic and Atherosclerosis Research Center

  • Dale R Wilson, MD, CCFP(EM), FCFP · KGK Science Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01375803 on ClinicalTrials.gov