Barley and Rice Mixture Effects on Blood Glucose

• Sponsor: Arizona State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03387345
• Collaborator: Ardent Mills, LLC (Other)
• Enrollment: 39
• Location: 1
• Arms: 6
• Actual Duration (Months): 7.1
• Patients Per Site Per Month: 5.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Glucose; Dietary Fiber; Hunger	Other: 100% steel cut barley; Other: 100% barley flakes; Other: 50/50 rice-barley mix; Other: 80/20 rice-barley mix; Other: 100% rice; Other: white bread	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Otherwise healthy male and female adultsOtherwise healthy male and female adults
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: β-glucan Rich Barley and Rice Mixes and Post-prandial Glycemia - a Dose Response Study
• Actual Study Start Date: Feb 13, 2017
• Actual Primary Completion Date: Sep 4, 2017
• Actual Study Completion Date: Sep 18, 2017

Arms and Interventions

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	Other: 100% steel cut barley; 25 g of available carbohydrate was delivered to participants via steel cut Sustagrain barley (Ardent Mills, LLC).; Other: 100% barley flakes; 25 g of available carbohydrate was delivered to participants via Sustagrain barley flakes (Ardent Mills, LLC).; Other: 50/50 rice-barley mix; 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).; Other: 80/20 rice-barley mix; 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).; Other: 100% rice; 25 g of available carbohydrate was delivered to participants via Goya medium grain white rice; Other: white bread; 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	Other: 100% steel cut barley; 25 g of available carbohydrate was delivered to participants via steel cut Sustagrain barley (Ardent Mills, LLC).; Other: 100% barley flakes; 25 g of available carbohydrate was delivered to participants via Sustagrain barley flakes (Ardent Mills, LLC).; Other: 50/50 rice-barley mix; 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).; Other: 80/20 rice-barley mix; 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).; Other: 100% rice; 25 g of available carbohydrate was delivered to participants via Goya medium grain white rice; Other: white bread; 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	Other: 100% steel cut barley; 25 g of available carbohydrate was delivered to participants via steel cut Sustagrain barley (Ardent Mills, LLC).; Other: 100% barley flakes; 25 g of available carbohydrate was delivered to participants via Sustagrain barley flakes (Ardent Mills, LLC).; Other: 50/50 rice-barley mix; 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).; Other: 80/20 rice-barley mix; 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).; Other: 100% rice; 25 g of available carbohydrate was delivered to participants via Goya medium grain white rice; Other: white bread; 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	Other: 100% steel cut barley; 25 g of available carbohydrate was delivered to participants via steel cut Sustagrain barley (Ardent Mills, LLC).; Other: 100% barley flakes; 25 g of available carbohydrate was delivered to participants via Sustagrain barley flakes (Ardent Mills, LLC).; Other: 50/50 rice-barley mix; 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).; Other: 80/20 rice-barley mix; 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).; Other: 100% rice; 25 g of available carbohydrate was delivered to participants via Goya medium grain white rice; Other: white bread; 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	Other: 100% steel cut barley; 25 g of available carbohydrate was delivered to participants via steel cut Sustagrain barley (Ardent Mills, LLC).; Other: 100% barley flakes; 25 g of available carbohydrate was delivered to participants via Sustagrain barley flakes (Ardent Mills, LLC).; Other: 50/50 rice-barley mix; 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).; Other: 80/20 rice-barley mix; 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).; Other: 100% rice; 25 g of available carbohydrate was delivered to participants via Goya medium grain white rice; Other: white bread; 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	Other: 100% steel cut barley; 25 g of available carbohydrate was delivered to participants via steel cut Sustagrain barley (Ardent Mills, LLC).; Other: 100% barley flakes; 25 g of available carbohydrate was delivered to participants via Sustagrain barley flakes (Ardent Mills, LLC).; Other: 50/50 rice-barley mix; 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).; Other: 80/20 rice-barley mix; 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).; Other: 100% rice; 25 g of available carbohydrate was delivered to participants via Goya medium grain white rice; Other: white bread; 25 g of available carbohydrate was delivered to participants via Sara Lee Classic White Bread (Bimbo Bakeries USA, Inc.)

Outcome Measures

Primary Outcome Measures

1. Post-prandial glycemia [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.

Secondary Outcome Measures

1. Self-reported hunger [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.

2. Self-reported satiety [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.

3. Self-reported fullness [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.

4. Self-reported prospective food consumption [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Biomedical Collaborative	Phoenix	Arizona	United States	85004

Sponsors and Collaborators

• Arizona State University
• Ardent Mills, LLC

Investigators

• Principal Investigator: Corrie M Whisner, PhD, Arizona State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Corrie Whisner, Assistant Professor, Arizona State University
• ClinicalTrials.gov Identifier: NCT03387345
• Other Study ID Numbers: STUDY00005413
• First Posted: Jan 2, 2018
• Last Update Posted: Jan 2, 2018
• Last Verified: Dec 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Corrie Whisner, Assistant Professor, Arizona State University: glucose; dietary fiber; glycemia; whole grain

Study Results

No Results Posted as of Jan 2, 2018