Blood Glucose Clinical Trial
Official title:
β-glucan Rich Barley and Rice Mixes and Post-prandial Glycemia - a Dose Response Study
Verified date | December 2017 |
Source | Arizona State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Arizona Biomedical Collaborative | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Arizona State University | Ardent Mills, LLC |
United States,
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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