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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04831268
Other study ID # HRBD 24 04/04/2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date September 30, 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 investigated the effects of Greek traditional meals in dehydrated form consumed after reconstitution with water on glycemic responses


Description:

This study aimed at 1. to determined the glycemic index and glycemic load of three mixed meals and 2. to investigate the effects of these mixed meals on postprandial glycemic response in healthy subjects


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date September 30, 2019
Est. primary completion date September 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - healthy - non-smoking - non-diabetic men and women - normal body mass index (BMI; between 18.5 and 25 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
Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g glucose diluted in 250ml water, tested three times, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
Lentils and lupins mixed meal
Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from lentils and lupins mixed meal along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
Trahanas with tomato sauce mixed meal
Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from trahanas with tomato sauce mixed meal along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
Halva with currants mixed meal
Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from halva with currants mixed meal along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were takenat 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 three mixed meals 2 hours
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