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Effects of Dietary Fiber on Insulin Sensitivity

Primary Purpose

Focus of the Study is Insulin Sensitivity

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dietary Fiber

About this trial

This is an interventional prevention trial for Focus of the Study is Insulin Sensitivity focused on measuring insulin sensitivity, resistant starch

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Impaired fasting glucose
Overweight and obese

Exclusion Criteria:

Diabetes, Presence of chronic diseases

Sites / Locations

Clinical Research Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Low dose

High dose

No fiber

Arm Description

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

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

Snack foods without fiber will be given

Outcomes

Primary Outcome Measures

Insulin sensitivity

A frequently sampled intravenous blood glucose tolerance test will be performed.

Secondary Outcome Measures

Mitocondrial function

A muscle biospy will be taken to assess mitochondrial function

Meal tolerance test

A high-fat meal will be given and blood will be drawn over a three-hr period

Full Information

NCT ID

NCT01521806

First Posted

January 20, 2012

Last Updated

January 26, 2012

Sponsor

Ingredion Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT01521806

Brief Title

Effects of Dietary Fiber on Insulin Sensitivity

Official Title

Effects of Dieatry Fiber on Insulin Sensitivity in Pre- and Post-menopausal Women

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Unknown status

Study Start Date

January 2012 (undefined)

Primary Completion Date

January 2012 (Anticipated)

Study Completion Date

September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ingredion Incorporated

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Focus of the Study is Insulin Sensitivity

Keywords

insulin sensitivity, resistant starch

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Low dose

Arm Type

Experimental

Arm Description

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

Arm Title

High dose

Arm Type

Experimental

Arm Description

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

Arm Title

No fiber

Arm Type

Placebo Comparator

Arm Description

Snack foods without fiber will be given

Intervention Type

Dietary Supplement

Intervention Name(s)

Dietary Fiber

Intervention Description

Dietary fiber will be added to snack foods

Primary Outcome Measure Information:

Title

Insulin sensitivity

Description

A frequently sampled intravenous blood glucose tolerance test will be performed.

Time Frame

5-hr test, performed 3 times within a 20-week period

Secondary Outcome Measure Information:

Title

Mitocondrial function

Description

A muscle biospy will be taken to assess mitochondrial function

Time Frame

3 times, with a 20-week period

Title

Meal tolerance test

Description

A high-fat meal will be given and blood will be drawn over a three-hr period

Time Frame

3 times, within a 20-week period

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Impaired fasting glucose Overweight and obese Exclusion Criteria: Diabetes, Presence of chronic diseases

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Brandon Kane

Phone

205-975-9629

kane003@uab.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barbara Gower, PhD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Research Unit

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35249

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brandon Kane

Phone

205-975-9629

kane003@uab.edu

First Name & Middle Initial & Last Name & Degree

Barbara Gower, PhD

12. IPD Sharing Statement

Links:

URL

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

Description

clinical center

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Effects of Dietary Fiber on Insulin Sensitivity

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