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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04858373
Other study ID # HRBD 39 12/07/2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2019
Est. completion date November 1, 2019

Study information

Verified date April 2021
Source Agricultural University of Athens
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date November 1, 2019
Est. primary completion date November 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Glucose as reference food
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.
Emmer bread from Greek emmer
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.
Emmer bread from Italian emmer
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.
Whole wheat commercial bread
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.

Locations

Country Name City State
Greece Agricultural University of Athens Athens Attica

Sponsors (1)

Lead Sponsor Collaborator
Agricultural University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Blood pressure Useful change in systolic and diastolic blood pressure before and 2hr after consumption of the breads 2 hours
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