Barley Beta-glucan, Glycemic Control, and Appetite

Study Overview
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Brief Summary
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Novel barley varieties high in the soluble fiber β-glucan have the capacity to improve population health through improving glycemic control. Sweetened and unsweetened wholegrain barley foods were tested in a randomized, controlled, crossover human clinical trial to assess impact on postprandial appetite and food intake.

Official Title
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Barley Beta-glucan, Glycemic Control, and Appetite

Conditions
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Diet, Healthy, Blood Sugar; High, Diabetes, Appetite and General Nutritional Disorders, Appetitive Behavior

Intervention / Treatment
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* Other: WR
* Other: LB
* Other: MB
* Other: HB
* Other: WR+50g HFCS
* Other: LB + 50 g HFCS
* Other: MB + 50 g HFCS
* Other: HB + 50 g HFCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-50 years of age Body Mass Index (BMI) values of 18.5-40.0 kg/m2 Normal fasting blood glucose (<100 mg/dL) Exclusion Criteria: Use of medications known to be associated with weight change (e.g., beta-blockers) Use of steroid pills or shots such as prednisone or cortisone Use of nicotine Weight change of ten or more pounds in the last three months Major daily variation in physical activity (e.g., athletes in training) History of extensive small bowel surgery or surgery to treat obesity History of heart attack, stroke, or bypass History of cancer within the last five years (exception: non-melanoma skin cancer) Recent or current medical diagnosis or medical treatment that would alter appetite, energy needs, satiety, and/or could impact the results of the trial Medical diagnoses of diabetes, cardiovascular disease, high levels of blood lipids, asthma, cold, and flu (exception: hypertension, if treated with medication prescribed more than three months prior to the screening activity) Fear of blood or needles Dietary restrictions that would interfere with consuming test foods (e.g., gluten intolerance, vegan, corn syrup allergy) Following a weight modification diet Sensitive to food textures present in the test foods Following personal schedules that would not permit attendance at all scheduled testing sessions Unable to comprehend the nature of the trial or instructions Unable to understand English sufficiently to complete the trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: WR|Unsweetened preload condition: 240 mL white glutinous rice, 250 kcal, 0 g β-glucan|
|Other: LB|Unsweetened preload condition: 240 mL low β-glucan barley, 250 kcal,  4 g β-glucan|
|Other: MB|Unsweetened preload condition: 240 mL medium β-glucan barley, 250 kcal,  5 g β-glucan|
|Other: HB|Unsweetened preload condition: 240 mL high β-glucan barley, 250 kcal,  6 g β-glucan|
|Other: WR+50g HFCS|Sweetened condition with high fructose corn syrup (HFCS): 240 mL white glutinous rice + 50g HFCS, 391 kcal, 0 g β-glucan|
|Other: LB + 50 g HFCS|Sweetened condition with high fructose corn syrup (HFCS): 240 mL low β-glucan barley + 50 g HFCS, 391 kcal,  4 g β-glucan|
|Other: MB + 50 g HFCS|Sweetened condition with high fructose corn syrup (HFCS): 240 mL medium β-glucan barley + 50 g HFCS, 391 kcal,  5 g β-glucan|
|Other: HB + 50 g HFCS|Sweetened condition with high fructose corn syrup (HFCS): 240 mL high β-glucan barley + 50 g HFCS, 391 kcal,  6 g β-glucan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial glycemic response | Blood glucose measured every 15 minutes post-preload ingestion | 4 hours | 
| Subjective appetite | Self-reported appetite measured using Visual Analogue Scale (VAS) every 15 minutes post-preload ingestion | 4 hours | 
| Food intake | Food intake at a 16-item ad libitum test meal served 4 hours post-preload ingestion | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Beta-glucan, Fiber, Glycemic Control, Appetite