Effects of Hi-maize Resistant Starch on Insulin Sensitivity

NCT ID: NCT01058135

Last Updated: 2016-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Hi-maize starch (Low dose)

resistant starch

Intervention Type OTHER

Hi-maize starch (High-dose)

resistant starch

Intervention Type OTHER

Control (starch)

rapidly digestible starch

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ingredion Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Provident Clinical Research and Consulting, Inc

Glen Ellyn, Illinois, United States

Site Status

Countries

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United States

References

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Maki KC, Pelkman CL, Finocchiaro ET, Kelley KM, Lawless AL, Schild AL, Rains TM. Resistant starch from high-amylose maize increases insulin sensitivity in overweight and obese men. J Nutr. 2012 Apr;142(4):717-23. doi: 10.3945/jn.111.152975. Epub 2012 Feb 22.

Reference Type DERIVED
PMID: 22357745 (View on PubMed)

Related Links

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Other Identifiers

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001

Identifier Type: -

Identifier Source: org_study_id

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