Characterizing Emmer Seeds and Flours, and Determining the Glycemic Effects of Emmer Breads

Study Overview
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Brief Summary
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This study characterized emmer seeds, flours, and breads, and investigated the effects of emmer breads on the glycemic response

Detailed Description
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This study aimed to 1. describe the technological characteristics of emmer seeds, flours, and breads, 2. determine the glycemic index and glycemic load of two emmer breads, and 3. to investigate the effects of these breads on postprandial glycemic response in healthy subjects

Official Title
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Characterizing the Technological Properties of Emmer Seeds, Flour, and Bread; and Determining the Effect of Emmer Breads on Glycemic Responses in Healthy Humans

Conditions
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Potential Abnormality of Glucose Tolerance, Appetitive Behavior

Intervention / Treatment
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* Other: Glucose as reference food
* Other: Emmer bread from Greek emmer
* Other: Emmer bread from Italian emmer
* Other: Whole wheat commercial bread


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy non-smoking non-diabetic men and women body mass index (BMI) between 18 and 27 kg/m2 Exclusion Criteria: severe chronic disease (e.g. coronary heart disease, diabetes mellitus,kidney or liver conditions, endocrine conditions) gastrointestinal disorders pregnancy lactation competitive sports alcohol drug dependency

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glucose as reference food<br>Fourteen healthy, normal weight subjects (male: 6, female: 8) after 12hr fast, consumed 50g available carbohydrates from D-glucose, three times, in different visits as reference food along with 300ml water; and 50g available carbohydrates from emmer bread from Greek emmer seeds, emmer bread from Italian emmer seeds, and whole wheat commercial soft bread, tested once, in different visits. there was a washout period of 2 days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose sample was taken exactly 15min after the first bite of food or drink. | Other: Glucose as reference food<br>* Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g glucose diluted in 300ml water, tested three times, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.<br>Other: Emmer bread from Greek emmer<br>* Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g available carbohydrates from Greek emmer bread, tested once, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.<br>Other: Emmer bread from Italian emmer<br>* Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g available carbohydrates from Italian emmer bread, tested once, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.<br>Other: Whole wheat commercial bread<br>* Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g available carbohydrates from whole wheat commercial bread, tested once, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.<br>|
| Experimental: Emmer bread from Greek emmer<br>Fourteen healthy, normal weight subjects (male: 6, female: 8) after 12hr fast, consumed 50g available carbohydrates from D-glucose, three times, in different visits as reference food along with 300ml water; and 50g available carbohydrates from emmer bread from Greek emmer seeds, emmer bread from Italian emmer seeds, and whole wheat commercial soft bread, tested once, in different visits. there was a washout period of 2 days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose sample was taken exactly 15min after the first bite of food or drink. | Other: Glucose as reference food<br>* Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g glucose diluted in 300ml water, tested three times, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.<br>Other: Emmer bread from Greek emmer<br>* Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g available carbohydrates from Greek emmer bread, tested once, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.<br>Other: Emmer bread from Italian emmer<br>* Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g available carbohydrates from Italian emmer bread, tested once, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.<br>Other: Whole wheat commercial bread<br>* Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g available carbohydrates from whole wheat commercial bread, tested once, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.<br>|
| Experimental: Emmer bread from Italian emmer<br>Fourteen healthy, normal weight subjects (male: 6, female: 8) after 12hr fast, consumed 50g available carbohydrates from D-glucose, three times, in different visits as reference food along with 300ml water; and 50g available carbohydrates from emmer bread from Greek emmer seeds, emmer bread from Italian emmer seeds, and whole wheat commercial soft bread, tested once, in different visits. there was a washout period of 2 days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose sample was taken exactly 15min after the first bite of food or drink. | Other: Glucose as reference food<br>* Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g glucose diluted in 300ml water, tested three times, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.<br>Other: Emmer bread from Greek emmer<br>* Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g available carbohydrates from Greek emmer bread, tested once, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.<br>Other: Emmer bread from Italian emmer<br>* Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g available carbohydrates from Italian emmer bread, tested once, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.<br>Other: Whole wheat commercial bread<br>* Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g available carbohydrates from whole wheat commercial bread, tested once, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.<br>|
| Experimental: Whole wheat commercial bread<br>Fourteen healthy, normal weight subjects (male: 6, female: 8) after 12hr fast, consumed 50g available carbohydrates from D-glucose, three times, in different visits as reference food along with 300ml water; and 50g available carbohydrates from emmer bread from Greek emmer seeds, emmer bread from Italian emmer seeds, and whole wheat commercial soft bread, tested once, in different visits. there was a washout period of 2 days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose sample was taken exactly 15min after the first bite of food or drink. | Other: Glucose as reference food<br>* Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g glucose diluted in 300ml water, tested three times, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.<br>Other: Emmer bread from Greek emmer<br>* Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g available carbohydrates from Greek emmer bread, tested once, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.<br>Other: Emmer bread from Italian emmer<br>* Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g available carbohydrates from Italian emmer bread, tested once, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.<br>Other: Whole wheat commercial bread<br>* Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g available carbohydrates from whole wheat commercial bread, tested once, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capillary blood glucose responses | Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during the 2hr glucose tolerance test | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective appetite ratings | Useful change in subjective appetite using visual analogue scales with a score 0 to 10 (given in the form of booklet,one scale per page) at baseline, 15, 30, 45, 60, 90 and 120 min. The minimum or maximum score will be evaluated if it is better or worse depending on the appetite variable e.g hunger, satiety, desire to eat etc. | 2 hours | 
| Blood pressure | Useful change in systolic and diastolic blood pressure before and 2hr after consumption of the breads | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glycemic load, blood pressure, blood glucose, emmer bread, glycemic index