Barley and Rice Mixture Effects on Blood Glucose

Blood Glucose Clinical Trial

Official title:

β-glucan Rich Barley and Rice Mixes and Post-prandial Glycemia - a Dose Response Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03387345
• Other study ID #: STUDY00005413
• 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
• 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

Related Conditions & MeSH terms

• Blood Glucose
• Dietary Fiber
• Hunger

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