Barley Tortillas Study in Healthy Volunteers

Study Overview
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Brief Summary
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The variation in starch and fibre composition of prepared barley tortillas will have a significant effect on glycemic response.

Detailed Description
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Specifically, we wish to examine the glycemic response of barley tortillas containing different ratios of amylose and amylopectin and different amounts of soluble and insoluble fibre with an appropriate control during acute phase testing in healthy volunteers. Possible relationships between composition of the barley tortillas and the degree of physiological response will also be investigated as the secondary objective.

Official Title
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A Double-Blind, Randomized, Controlled Study to Examine the Glycemic Response of Barley Tortillas in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: food product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female age 18 to 40 years normal glycated hemoglobin of <6% BMI of 20 to 30 must read the consent form must comply with the protocol requirements Exclusion Criteria: allergies to barley flour presence of chronic conditions such as cardiovascular disease, hypertension, disorders affecting the gastrointestinal tract, thyroid disease, and requiring medication for these conditions requiring medication for glycemic control consumption of supplements which have an effect on blood glucose response

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tortilla with high amylose flour<br> | Dietary Supplement: food product<br>* food product given at one of six visits<br>|
| Experimental: barley tortilla with low amylose flour<br> | Dietary Supplement: food product<br>* food product given at one of six visits<br>|
| Experimental: barley tortilla with low amylose flour and soluble fibre<br> | Dietary Supplement: food product<br>* food product given at one of six visits<br>|
| Experimental: barley tortilla with low amylose flour and insoluble fibre<br> | Dietary Supplement: food product<br>* food product given at one of six visits<br>|
| Active Comparator: glucose<br> | Dietary Supplement: food product<br>* food product given at one of six visits<br>|
| Experimental: barley tortilla with low amylose flour and low soluble fibre<br> | Dietary Supplement: food product<br>* food product given at one of six visits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculation of area under the curve for glucose and insulin |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of food groups using ANOVA |  | 6 weeks | 
| measurement of incretins |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteers