Effect of Consuming Oat Bran Mixed in Water Before a Meal on Glycemic Responses in Healthy Humans - a Pilot Study

NCT ID: NCT02801916

Last Updated: 2016-06-16

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-05-31

Brief Summary

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Viscous dietary fibers including oat β-glucan are one of the most effective classes of functional food ingredients for reducing postprandial blood glucose. The mechanism of action is thought to be via an increase in viscosity of the stomach contents that delays gastric emptying and reduces mixing of food with digestive enzymes, which, in turn, retards glucose absorption. Previous studies suggest that taking viscous fibers separate from a meal may not be effective in reducing postprandial glycemia. The purpose of this study is to re-assess the effect of consuming a preload of a commercially available oat-bran (4.5, 13.6 or 27.3 g) containing 22% of high molecular weight oat β-glucan (O22) mixed in water before a test-meal of white bread on glycemic responses in 10 healthy humans.

Detailed Description

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Conditions

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Glucose Intolerance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Study subjects

Each healthy subject will receive each of the interventions in randomized order.

Group Type OTHER

0 grams oat bran

Intervention Type OTHER

200 milliliters water plus 0 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread

4.5 grams oat bran

Intervention Type OTHER

200 milliliters water plus 4.5 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread

13.6 grams oat bran

Intervention Type OTHER

200 milliliters water plus 13.6 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread

27.3 grams oat bran

Intervention Type OTHER

200 milliliters water plus 27.3 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread

Interventions

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0 grams oat bran

200 milliliters water plus 0 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread

Intervention Type OTHER

4.5 grams oat bran

200 milliliters water plus 4.5 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread

Intervention Type OTHER

13.6 grams oat bran

200 milliliters water plus 13.6 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread

Intervention Type OTHER

27.3 grams oat bran

200 milliliters water plus 27.3 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects

Exclusion Criteria

* Pregnancy
* Diabetes
* Recent medical or surgical hospitalization
* Use of drugs influencing glucose metabolism
* Use of drugs influencing gastrointestinal function
* Allergy to oats or wheat
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role collaborator

Glycemic Index Laboratories, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas MS Wolever, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Glycemic Index Laboratories, Inc

Other Identifiers

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GIL1527b

Identifier Type: -

Identifier Source: org_study_id

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