- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03387345
Barley and Rice Mixture Effects on Blood Glucose
December 28, 2017 updated by: Corrie Whisner, Arizona State University
β-glucan Rich Barley and Rice Mixes and Post-prandial Glycemia - a Dose Response Study
The purpose of this research was to investigate 5 different formulations of whole grain barley and refined white rice against a control of white bread on post-prandial glycemic response, as well as self-reported hunger/satiety in a randomized cross-over trial.
Study Overview
Status
Completed
Conditions
Detailed Description
Beta-glucan-rich barley has been shown to improve glycemic response, reduce hunger and increase satiety.
Nutrient-dense grain mixtures that include a new cultivar of barley (Sustagrain, Ardent Mills, LLC) with exceptionally high dietary fiber content may help individuals meet their dietary fiber needs while minimizing the rapid increase in blood glucose following the consumption of a refined grain product.
The primary objective of this study was to compare the effects of five different test meals containing varying amounts of whole-grain barley and refined white rice to white bread on post-prandial blood glucose concentrations.
A secondary aim was to evaluate changes in self-reported hunger and satiety following the consumption of each treatment.
This study was a single-site, blinded, randomized crossover trial among 24 healthy adults.
Each participant consumed the following treatments: 100% Sustagrain barley flakes, 100% Sustagrain steel cut barley , an 80/20 rice-steel cut Sustagrain barley mix, a 50/50 rice-steel cut Sustagrain barley mix, 100% rice, and white bread.
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85004
- Arizona Biomedical Collaborative
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy, English speaking adults;
- BMI between 18 and 30 kg/m2
Exclusion Criteria:
- History of GI malabsorption diseases, food allergy or intolerance to gluten;
- Prediabetes, and/or diabetes, and/or treatment with diabetic medications for any reason;
- Hypertension, hypothyroidism and other chronic disease that affects nutrient metabolism;
- Any women pregnant or lactating, or expecting to become pregnant during the study;
- Individuals with a history of bleeding disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: bread-50/50-steelcut-80/20-flake-rice
25 g of available carbohydrate was delivered to participants via (1) white bread, followed by (2) 50/50 rice-barley mix, followed by (3) 100% steel cut barley, followed by (4) 80/20 rice-barley mix, followed by (5) 100% barley flakes, followed by (6) 100% rice
|
25 g of available carbohydrate was delivered to participants via steel cut Sustagrain barley (Ardent Mills, LLC).
25 g of available carbohydrate was delivered to participants via Sustagrain barley flakes (Ardent Mills, LLC).
25 g of available carbohydrate was delivered to participants via a 50/50 mixture (by weight) of Goya medium grain white rice and steel cut Sustagrain barley (Ardent Mills, LLC).
25 g of available carbohydrate was delivered to participants via a 80/20 mixture (by weight) of Goya medium grain white rice and steel cut Sustagrain barley (Ardent Mills, LLC).
25 g of available carbohydrate was delivered to participants via Goya medium grain white rice
25 g of available carbohydrate was delivered to participants via Sara Lee Classic White Bread (Bimbo Bakeries USA, Inc.)
|
Experimental: 50/50-steelcut-80/20-flake-rice-bread
25 g of available carbohydrate was delivered to participants via (1) 50/50 rice-barley mix, followed by (2) 100% steel cut barley, followed by (3) 80/20 rice-barley mix, followed by (4) 100% barley flakes, followed by (5) 100% rice, followed by (6) white bread
|
25 g of available carbohydrate was delivered to participants via steel cut Sustagrain barley (Ardent Mills, LLC).
25 g of available carbohydrate was delivered to participants via Sustagrain barley flakes (Ardent Mills, LLC).
25 g of available carbohydrate was delivered to participants via a 50/50 mixture (by weight) of Goya medium grain white rice and steel cut Sustagrain barley (Ardent Mills, LLC).
25 g of available carbohydrate was delivered to participants via a 80/20 mixture (by weight) of Goya medium grain white rice and steel cut Sustagrain barley (Ardent Mills, LLC).
25 g of available carbohydrate was delivered to participants via Goya medium grain white rice
25 g of available carbohydrate was delivered to participants via Sara Lee Classic White Bread (Bimbo Bakeries USA, Inc.)
|
Experimental: steelcut-80/20-flake-rice-bread-50/50
25 g of available carbohydrate was delivered to participants via (1) 100% steel cut barley, followed by (2) 80/20 rice-barley mix, followed by (3) 100% barley flakes, followed by (4) 100% rice, followed by (5) white bread, followed by (6) 50/50 rice-barley mix
|
25 g of available carbohydrate was delivered to participants via steel cut Sustagrain barley (Ardent Mills, LLC).
25 g of available carbohydrate was delivered to participants via Sustagrain barley flakes (Ardent Mills, LLC).
25 g of available carbohydrate was delivered to participants via a 50/50 mixture (by weight) of Goya medium grain white rice and steel cut Sustagrain barley (Ardent Mills, LLC).
25 g of available carbohydrate was delivered to participants via a 80/20 mixture (by weight) of Goya medium grain white rice and steel cut Sustagrain barley (Ardent Mills, LLC).
25 g of available carbohydrate was delivered to participants via Goya medium grain white rice
25 g of available carbohydrate was delivered to participants via Sara Lee Classic White Bread (Bimbo Bakeries USA, Inc.)
|
Experimental: 80/20-flake-rice-bread-50/50-steelcut
25 g of available carbohydrate was delivered to participants via (1) 80/20 rice-barley mix, followed by (2) 100% barley flakes, followed by (3) 100% rice, followed by (4) white bread, followed by (5) 50/50 rice-barley mix, followed by (6) 100% steel cut barley
|
25 g of available carbohydrate was delivered to participants via steel cut Sustagrain barley (Ardent Mills, LLC).
25 g of available carbohydrate was delivered to participants via Sustagrain barley flakes (Ardent Mills, LLC).
25 g of available carbohydrate was delivered to participants via a 50/50 mixture (by weight) of Goya medium grain white rice and steel cut Sustagrain barley (Ardent Mills, LLC).
25 g of available carbohydrate was delivered to participants via a 80/20 mixture (by weight) of Goya medium grain white rice and steel cut Sustagrain barley (Ardent Mills, LLC).
25 g of available carbohydrate was delivered to participants via Goya medium grain white rice
25 g of available carbohydrate was delivered to participants via Sara Lee Classic White Bread (Bimbo Bakeries USA, Inc.)
|
Experimental: flake-rice-bread-50/50-steelcut-80/20
25 g of available carbohydrate was delivered to participants via (1) 100% barley flakes, followed by (2) 100% rice, followed by (3) white bread, followed by (4) 50/50 rice-barley mix, followed by (5) 100% steel cut barley, followed by (6) 80/20 rice-barley mix
|
25 g of available carbohydrate was delivered to participants via steel cut Sustagrain barley (Ardent Mills, LLC).
25 g of available carbohydrate was delivered to participants via Sustagrain barley flakes (Ardent Mills, LLC).
25 g of available carbohydrate was delivered to participants via a 50/50 mixture (by weight) of Goya medium grain white rice and steel cut Sustagrain barley (Ardent Mills, LLC).
25 g of available carbohydrate was delivered to participants via a 80/20 mixture (by weight) of Goya medium grain white rice and steel cut Sustagrain barley (Ardent Mills, LLC).
25 g of available carbohydrate was delivered to participants via Goya medium grain white rice
25 g of available carbohydrate was delivered to participants via Sara Lee Classic White Bread (Bimbo Bakeries USA, Inc.)
|
Experimental: rice-bread-50/50-steelcut-80/20-flake
25 g of available carbohydrate was delivered to participants via (1) 100% rice, followed by (2) white bread, followed by (3) 50/50 rice-barley mix, followed by (4) 100% steel cut barley, followed by (5) 80/20 rice-barley mix, followed by (6) 100% barley flakes
|
25 g of available carbohydrate was delivered to participants via steel cut Sustagrain barley (Ardent Mills, LLC).
25 g of available carbohydrate was delivered to participants via Sustagrain barley flakes (Ardent Mills, LLC).
25 g of available carbohydrate was delivered to participants via a 50/50 mixture (by weight) of Goya medium grain white rice and steel cut Sustagrain barley (Ardent Mills, LLC).
25 g of available carbohydrate was delivered to participants via a 80/20 mixture (by weight) of Goya medium grain white rice and steel cut Sustagrain barley (Ardent Mills, LLC).
25 g of available carbohydrate was delivered to participants via Goya medium grain white rice
25 g of available carbohydrate was delivered to participants via Sara Lee Classic White Bread (Bimbo Bakeries USA, Inc.)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-prandial glycemia
Time Frame: 0 min, 15 min, 30 min, 45min , 60 min, 90 min, 120 min
|
Incremental area under the curve(iAUC) for plasma glucose concentrations were measured at 0, 15, 30, 45, 60, 90 and 120 min using the trapezoidal method to evaluate the glycemic response to each grain treatment.
|
0 min, 15 min, 30 min, 45min , 60 min, 90 min, 120 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported hunger
Time Frame: 0 min, 15 min, 30 min, 60 min, 90 min, 120 min
|
Visual analog scales were used to evaluate self-reported feelings of hunger using the question "How hungry do you feel?"
The scale consisted of a 100-millimeter line with anchors "I am not hungry at all" and "I have never been more hungry" at 0 and 100 millimeters, respectively.
Lower numbers represent low feelings of hunger while larger values are characteristic of greater hunger.
Hunger was assessed at 0, 15, 30, 60, 90 and 120 minutes to evaluate changes across time for each grain treatment.
|
0 min, 15 min, 30 min, 60 min, 90 min, 120 min
|
Self-reported satiety
Time Frame: 0 min, 15 min, 30 min, 60 min, 90 min, 120 min
|
Visual analog scales were used to evaluate self-reported feelings of satiety using the question "How satisfied do you feel?"
The scale consisted of a 100-millimeter line with anchors "I am completely empty" and "I cannot eat another bite" at 0 and 100 millimeters, respectively.
Lower numbers represent low feelings of satiety while larger values are characteristic of greater satiety.
Satiety was assessed at 0, 15, 30, 60, 90 and 120 minutes to evaluate changes across time for each grain treatment.
|
0 min, 15 min, 30 min, 60 min, 90 min, 120 min
|
Self-reported fullness
Time Frame: 0 min, 15 min, 30 min, 60 min, 90 min, 120 min
|
Visual analog scales were used to evaluate self-reported feelings of fullness using the question "How full do you feel?"
The scale consisted of a 100-millimeter line with anchors "Not at all full" and "Totally full" at 0 and 100 millimeters, respectively.
Lower numbers represent low feelings of fullness while larger values are characteristic of greater fullness.
Fullness was assessed at 0, 15, 30, 60, 90 and 120 minutes to evaluate changes across time for each grain treatment.
|
0 min, 15 min, 30 min, 60 min, 90 min, 120 min
|
Self-reported prospective food consumption
Time Frame: 0 min, 15 min, 30 min, 60 min, 90 min, 120 min
|
Visual analog scales were used to evaluate self-reported feelings toward prospective food consumption using the question "How much do you think you can eat?"
The scale consisted of a 100-millimeter line with anchors "Nothing at all" and "A lot" at 0 and 100 millimeters, respectively.
Lower numbers represent low ability to eat while larger values are characteristic of greater ability to eat.
Prospective food consumption was assessed at 0, 15, 30, 60, 90 and 120 minutes to evaluate changes across time for each grain treatment.
|
0 min, 15 min, 30 min, 60 min, 90 min, 120 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 13, 2017
Primary Completion (Actual)
September 4, 2017
Study Completion (Actual)
September 18, 2017
Study Registration Dates
First Submitted
December 19, 2017
First Submitted That Met QC Criteria
December 28, 2017
First Posted (Actual)
January 2, 2018
Study Record Updates
Last Update Posted (Actual)
January 2, 2018
Last Update Submitted That Met QC Criteria
December 28, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00005413
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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