Effects of Hi-maize Resistant Starch on Insulin Sensitivity

April 20, 2016 updated by: Ingredion Incorporated

A Randomized, Controlled, Double-blind Crossover Study to Assess the Effects of a Dietary Fiber Ingredient, at Two Doses, on Insulin Sensitivity

The purpose of this study is to determine the effects of a dietary fiber, resistant starch, on insulin sensitivity. Low insulin sensitivity is a risk factor for some diseases including type 2 diabetes and heart disease. This study will show if consuming resistant starch can help improve insulin sensitivity in overweight and obese people.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Glen Ellyn, Illinois, United States, 60137
        • Provident Clinical Research and Consulting, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stable body weight
  • No serious health conditions
  • Waist circumference > or = to 89 cm (females) and 102 cm (males)

Exclusion Criteria:

  • Diabetes
  • other serious illnesses
  • use of medications that affect outcomes
  • BMI > or = 35.0 kg/m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
insulin sensitivity
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Inflammatory markers, glycemia, serum lipids
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ingredion Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

January 26, 2010

First Submitted That Met QC Criteria

January 27, 2010

First Posted (Estimate)

January 28, 2010

Study Record Updates

Last Update Posted (Estimate)

April 21, 2016

Last Update Submitted That Met QC Criteria

April 20, 2016

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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