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Barley and Rice Mixture Effects on Blood Glucose

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ClinicalTrials.gov Identifier: NCT03387345
Recruitment Status : Completed
First Posted : January 2, 2018
Last Update Posted : January 2, 2018
Sponsor:
Collaborator:
Ardent Mills, LLC
Information provided by (Responsible Party):
Corrie Whisner, Arizona State University

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 Not Applicable

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  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Otherwise 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 : February 13, 2017
Actual Primary Completion Date : September 4, 2017
Actual Study Completion Date : September 18, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

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.)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387345


Locations
United States, Arizona
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

Responsible Party: Corrie Whisner, Assistant Professor, Arizona State University
ClinicalTrials.gov Identifier: NCT03387345     History of Changes
Other Study ID Numbers: STUDY00005413
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: January 2, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
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, Arizona State University:
glucose
dietary fiber
glycemia
whole grain