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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06163937
Other study ID # HRBD 67/06.09.2023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date October 30, 2023

Study information

Verified date June 2024
Source Agricultural University of Athens
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study investigated the acute effects of two fruit juices on postprandial glycemic responses and satiety in healthy individuals


Description:

This study aimed to 1. Determine the glycemic index and glycemic load of two types of fruit juices (orange juice and mixed fruit juice consisted of apple, orange, grape, and pomegranate) and 2. Investigate the effects of these two fruit juices on postprandial glycemic responses and satiety in healthy individuals


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date October 30, 2023
Est. primary completion date October 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - healthy - non-smoking - non-diabetic and normotensive men and women - body mass index between 18.5 and 25 kg/m2 Exclusion Criteria: - severe chronic disease (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver conditions, endocrine conditions) - gastrointestinal disorders - pregnancy - lactation - competitive sports - alcohol abuse - drug dependency

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Glucose as reference food
Ten healthy, normal-weight subjects after 10-14 hours of fasting, 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 120 min.
Orange juice
Ten healthy, normal-weight subjects after 10-14 hours of fasting, consumed 50g available carbohydrates from orange juice, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
Mixed fruit juice
Ten healthy, normal-weight subjects after 10-14 hours of fasting, consumed 50g available carbohydrates from mixed fruit juice (consisted of apple, orange, grape, and pomegranate), tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.

Locations

Country Name City State
Greece Agricultural University of Athens Athens Attica
Greece Agricultural University of Athens Athens

Sponsors (2)

Lead Sponsor Collaborator
Agricultural University of Athens Institute of Technology and Agricultural Products

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glycemic index Glucose solution (50 g) was the reference food (GI = 100%) against which all test foods were compared. Subjects arrived at the laboratory at eight to nine o'clock in the morning after 10-12 h overnight fast. Each subject was fed equivalent 50 g available carbohydrate of test foods or reference food in random order. To minimize day to day variation of glucose tolerance, the reference food was tested in triplicate in each subject. All test and reference foods were served with 250 mL of water. An automatic lancet device and glucometer (calibrated MediSmart Ruby glucose meter with a lancing device, Lilly-PHARMASERV SA, Greece) was used for finger capillary blood samples. Blood samples were taken immediately before the start of the study (0 min) and 15, 30, 45, 60, 90 and 120 min after the start of eating. 2 hours
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 120min. 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 2 hours post-consumption of tested beverages 2 hours
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