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

Glucose Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02801916
• Other study ID #: GIL1527b
• Status: Completed
• Phase: N/A
• First received: June 13, 2016
• Last updated: June 15, 2016
• Start date: April 2015
• Est. completion date: May 2015

Study information

• Verified date: June 2016
• Source: Glycemic Index Laboratories, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Glucose Intolerance

Intervention

Other:
• 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
• 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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Glycemic Index Laboratories, Inc	DSM Nutritional Products, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose AUC	Incremental area under the blood glucose response curve from 0 hours (fasting) to 2 hours after eating ignoring area below fasting	0 to 2 hours after test meal	No
Secondary	Peak rise of blood glucose	Highest concentration of blood glucose within 2 hours of eating minus the fasting glucose concentration	0 to 2 hours after test meal	No