A Study of the Effect of Oats on Post Prandial Glucose Response

Study Overview
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Brief Summary
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The objectives are to assess the effects of high viscosity vs. medium and low viscosity oat β-glucan on post-prandial glycemic response in healthy adult participants.

Detailed Description
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The trial will be a 3 week double-blinded, randomized, cross-over design with 3 treatment intervention (oatmeal breakfasts costain low, medium and high viscosity of beta glucan) periods separated by about 5-7 days washout period. Normoglycemic (<5.6 mmol/L) males and females (12 of each) of age 18-45 y with a body mass index (BMI) of 18.5-29.9 kg/m2 will be recruited. Each participant will receive each of the following breakfast foods in a random order: 1) oat meal containing low viscosity beta glucan; 2) oat meal containing medium viscosity beta glucan; 3) oat meal containing high viscosity beta glucan. The participants will be asked to consume one of the breakfast foods during each visit. Following each blood sample, appetite, physical comfort, energy/fatigue, and palatability of treatments will be measured by visual analogue scales (VAS). Glucose measurements: Capillary blood will be collected during each visit by finger prick. Blood will be collected at fasting and at 15, 30, 45, 60, 90 and 120 minutes after the first bite/sip of the test product according to the Clinical Laboratory Standard Institute (CLSI) guidelines. Blood glucose will be measured in finger prick blood samples by glucose meters . Males will be scheduled for three sessions over 3 weeks. Women will be scheduled during the first two weeks of their menstrual cycle (follicular phase), once per week. During the wash-out days (5 - 7 days between each phase), participants can go about their daily activities unrestricted with the following exception: no strenuous activity or alcohol consumption on the days before the clinic visit. The investigators will ask that participants go to sleep at the same time on the days before the sessions.

Official Title
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A Randomized, Controlled, Cross-over Study of the Effect of Oats on Post Prandial Glucose Response

Conditions
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Normoglycemic, Normal Body Weight

Intervention / Treatment
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* Other: Oatmeal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normoglycemic (<5.6 mmol/L) BMI= 18.5-29.9 kg/m² Exclusion Criteria: A change in medication (dose or type) or medical event requiring hospitalization within the past month. Daily tobacco use. Eat meals at irregular or unusual times. Food allergy, aversion or unwillingness to eat study foods. Use of any prescription or non-prescription drug, herbal or nutritional supplement known to affect blood sugar. Presence of a gastrointestinal disorder. Currently pregnant or lactating.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Viscous<br>Low Viscous Beta Glucan Oatmeal | Other: Oatmeal<br> <br> |
| Experimental: Medium Viscous<br>Medium Viscous Beta Glucan Oatmeal | Other: Oatmeal<br> <br> |
| Experimental: High Viscous<br>High Viscous Beta Glucan Oatmeal | Other: Oatmeal<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Glucose | Total area under the curve (iAUC, mmol*min/L) for glucose | 0-200 mins | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite (visual analogue scales) | Measured by VAS questionnaire at 12 time points used to calculate area under curve | 0-200 mins | 
| Physical Comfort | Measured by VAS questionnaire at 12 time points used to calculate area under curve | 0-200 mins | 
| Energy/Fatigue | Measured by VAS questionnaire at 12 time points used to calculate area under curve | 0-200mins | 
| Palatability | Measured by VAS questionnaire at 12 time points used to calculate area under curve | at 5 mins | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oatmeal, Beta glucan, Postprandial Glycemic Response, Blood Glucose