Back to resultsEffect of Consuming Oat Bran Mixed in Water Before a Meal on Glycemic Responses in Healthy Humans - a Pilot Study
Primary Purpose
Glucose Intolerance
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
0 grams oat bran
4.5 grams oat bran
13.6 grams oat bran
27.3 grams oat bran
Sponsored by
About this trial
This is an interventional prevention trial for Glucose Intolerance focused on measuring Humans, Glycemic response, Oat beta-glucan
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Study subjects
Arm Description
Each healthy subject will receive each of the interventions in randomized order.
Outcomes
Primary Outcome Measures
Glucose AUC
Incremental area under the blood glucose response curve from 0 hours (fasting) to 2 hours after eating ignoring area below fasting
Secondary Outcome Measures
Peak rise of blood glucose
Highest concentration of blood glucose within 2 hours of eating minus the fasting glucose concentration
Full Information
NCT ID
NCT02801916
First Posted
June 13, 2016
Last Updated
June 15, 2016
Sponsor
Glycemic Index Laboratories, Inc
Collaborators
DSM Nutritional Products, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02801916
Brief Title
Effect of Consuming Oat Bran Mixed in Water Before a Meal on Glycemic Responses in Healthy Humans - a Pilot Study
Official Title
Effect of Consuming Oat Bran Mixed in Water Before a Meal on Glycemic Responses in Healthy Humans - a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glycemic Index Laboratories, Inc
Collaborators
DSM Nutritional Products, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Intolerance
Keywords
Humans, Glycemic response, Oat beta-glucan
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study subjects
Arm Type
Other
Arm Description
Each healthy subject will receive each of the interventions in randomized order.
Intervention Type
Other
Intervention Name(s)
0 grams oat bran
Intervention Description
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
Intervention Name(s)
4.5 grams oat bran
Intervention Description
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
Intervention Name(s)
13.6 grams oat bran
Intervention Description
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
Intervention Name(s)
27.3 grams oat bran
Intervention Description
200 milliliters water plus 27.3 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread
Primary Outcome Measure Information:
Title
Glucose AUC
Description
Incremental area under the blood glucose response curve from 0 hours (fasting) to 2 hours after eating ignoring area below fasting
Time Frame
0 to 2 hours after test meal
Secondary Outcome Measure Information:
Title
Peak rise of blood glucose
Description
Highest concentration of blood glucose within 2 hours of eating minus the fasting glucose concentration
Time Frame
0 to 2 hours after test meal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas MS Wolever, MD, PhD
Organizational Affiliation
Glycemic Index Laboratories, Inc
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Consuming Oat Bran Mixed in Water Before a Meal on Glycemic Responses in Healthy Humans - a Pilot Study
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