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Effects of Dietary Fiber on Insulin Sensitivity

NCT ID: NCT01521806

Last Updated: 2012-01-31

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-09-30

Brief Summary

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This study will examine the effects of a dietary fiber on insulin sensitivity in overweight and obese women. The fiber will be added to snack foods and women will consume the foods for four weeks. In one four-week period, 15 g of fiber will be added, and 30 g will added in another period. In a third period, no fiber will be added to the snack foods. Insulin senstivity will be measured at the end of each treatment period.

Detailed Description

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Conditions

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Focus of the Study is Insulin Sensitivity

Keywords

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insulin sensitivity resistant starch

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Low dose

15 g of fiber per day will be added to snack foods

Group Type EXPERIMENTAL

Dietary Fiber

Intervention Type DIETARY_SUPPLEMENT

Dietary fiber will be added to snack foods

High dose

30 g of fiber per day will be added to snack foods

Group Type EXPERIMENTAL

Dietary Fiber

Intervention Type DIETARY_SUPPLEMENT

Dietary fiber will be added to snack foods

No fiber

Snack foods without fiber will be given

Group Type PLACEBO_COMPARATOR

Dietary Fiber

Intervention Type DIETARY_SUPPLEMENT

Dietary fiber will be added to snack foods

Interventions

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Dietary Fiber

Dietary fiber will be added to snack foods

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Impaired fasting glucose
* Overweight and obese

Exclusion Criteria

* Diabetes, Presence of chronic diseases
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ingredion Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barbara Gower, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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Clinical Research Unit

Birmingham, Alabama, United States

Site Status

Countries

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United States

Central Contacts

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Brandon Kane

Role: CONTACT

Phone: 205-975-9629

Email: [email protected]

Facility Contacts

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Brandon Kane

Role: primary

Related Links

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http://www.uab.edu/cores/clinical-research-unit-cru

clinical center

Other Identifiers

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HM001

Identifier Type: -

Identifier Source: org_study_id