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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03387345
Other study ID # STUDY00005413
Secondary ID
Status Completed
Phase N/A
First received December 19, 2017
Last updated December 28, 2017
Start date February 13, 2017
Est. completion date September 18, 2017

Study information

Verified date December 2017
Source Arizona State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date September 18, 2017
Est. primary completion date September 4, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Arizona Biomedical Collaborative Phoenix Arizona

Sponsors (2)

Lead Sponsor Collaborator
Arizona State University Ardent Mills, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-prandial glycemia 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 Self-reported hunger 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
Secondary Self-reported satiety 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
Secondary Self-reported fullness 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
Secondary Self-reported prospective food consumption 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
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