- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06163937
Acute Effects of Fruit Juices Consumption on Postprandial Glycemic Responses and Satiety
June 13, 2024 updated by: Aimilia Papakonstantinou, Agricultural University of Athens
Examining the Acute Effects of Two Different Fruit Juices (Orange Juice and Mixed Fruit Juice Consisted of Apple, Orange, Grape, and Pomegranate) on Postprandial Glycemic Responses and Satiety in Healthy Individuals
This study investigated the acute effects of two fruit juices on postprandial glycemic responses and satiety in healthy individuals
Study Overview
Status
Completed
Intervention / Treatment
Detailed 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
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Athens, Greece, 11855
- Agricultural University of Athens
-
-
Attica
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Athens, Attica, Greece, 11855
- Agricultural University of Athens
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Glucose as reference food
Ten healthy, normal-weight adults after 10-14 hours of fasting, consumed 50g available carbohydrates from D-glucose, tested three times, in different visits as reference food; and 50g available carbohydrates from orange juice and mixed fruit juice (consisted of apple, orange, grape, and pomegranate), each tested once, in different visits, along with 300mL water.
There was a washout period of at least two days between visits.
Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after beverage consumption.
The first glucose sample was taken exactly 15min after the first sip of drink.
|
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.
|
|
Experimental: Orange juice
Ten healthy, normal-weight adults after 10-14 hours of fasting, consumed 50g available carbohydrates from D-glucose, tested three times, in different visits as reference food; and 50g available carbohydrates from orange juice and mixed fruit juice (consisted of apple, orange, grape, and pomegranate), each tested once, in different visits, along with 300mL water.
There was a washout period of at least two days between visits.
Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after beverage consumption.
The first glucose sample was taken exactly 15min after the first sip of drink.
|
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.
|
|
Experimental: Mixed fruit juice
Ten healthy, normal-weight adults after 10-14 hours of fasting, consumed 50g available carbohydrates from D-glucose, tested three times, in different visits as reference food; and 50g available carbohydrates from orange juice and mixed fruit juice (consisted of apple, orange, grape, and pomegranate), each tested once, in different visits, along with 300mL water.
There was a washout period of at least two days between visits.
Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after beverage consumption.
The first glucose sample was taken exactly 15min after the first sip of drink.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Capillary blood glucose responses
Time Frame: 2 hours
|
Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during the 2hr glucose tolerance test
|
2 hours
|
|
Glycemic index
Time Frame: 2 hours
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective appetite ratings
Time Frame: 2 hours
|
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
|
|
Blood pressure
Time Frame: 2 hours
|
Useful change in systolic and diastolic blood pressure 2 hours post-consumption of tested beverages
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Emilia Papakonstantinou, PhD, Agricultural University of Athens
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2023
Primary Completion (Actual)
October 15, 2023
Study Completion (Actual)
October 30, 2023
Study Registration Dates
First Submitted
December 1, 2023
First Submitted That Met QC Criteria
December 1, 2023
First Posted (Actual)
December 11, 2023
Study Record Updates
Last Update Posted (Actual)
June 14, 2024
Last Update Submitted That Met QC Criteria
June 13, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HRBD 67/06.09.2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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