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

NCT02801916 | Completed

• 1 other identifier: GIL1527b
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Glucose Intolerance

Keywords

Humans; Glycemic response; Oat beta-glucan

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Peak rise of blood glucose

  0 to 2 hours after test meal

Study Arms (1)

Study subjects

OTHER

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

Other: 0 grams oat bran; Other: 4.5 grams oat bran; Other: 13.6 grams oat bran; Other: 27.3 grams oat bran

Interventions

0 grams oat bran OTHER

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

Study subjects

4.5 grams oat bran 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

Study subjects

13.6 grams oat bran 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

Study subjects

27.3 grams oat bran 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

Study subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects

You may not qualify if:

• Pregnancy
• Diabetes
• Recent medical or surgical hospitalization
• Use of drugs influencing glucose metabolism
• Use of drugs influencing gastrointestinal function
• Allergy to oats or wheat

Sponsors & Collaborators

• Glycemic Index Laboratories, Inc: lead
• DSM Nutritional Products, Inc.: collaborator

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Thomas MS Wolever, MD, PhD

  Glycemic Index Laboratories, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: June 16, 2016
• Study Start: April 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 16, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share