Potential Abnormality of Glucose ToleranceNCT06163937
Acute Effects of Fruit Juices Consumption on Postprandial Glycemic Responses and Satiety
A study testing Glucose as reference food, Orange juice and Mixed fruit juice in people with Potential Abnormality of Glucose Tolerance and Appetitive Behavior, run by Agricultural University of Athens at 2 sites in Greece.
Trial summary
This study investigated the acute effects of two fruit juices on postprandial glycemic responses and satiety in healthy individuals Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Potential Abnormality of Glucose Tolerance, Appetitive Behavior
- What is being tested?
- Glucose as reference food, Orange juice and Mixed fruit juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesGreece
- Study dates
- 1 Sep 2023to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- non-smoking
- non-diabetic and normotensive men and women
- body mass index between 18.5 and 25 kg/m2
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Agricultural University of Athens
Athens, Attica, 11855
Agricultural University of Athens
Athens, 11855
About this study
Official title: 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
Read the 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
- Being tested
- Glucose as reference food, Orange juice, Mixed fruit juice
- Keywords
- blood glucose, fruit juice, glycemic index, glycemic load, satiety
- Medical subject headings
- Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose as reference foodOther
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 juiceOther
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 juiceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Glucose as reference food | Experimental | 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. Receives: Other: Glucose as reference food |
| Orange juice | Experimental | 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. Receives: Other: Orange juice |
| Mixed fruit juice | Experimental | 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. Receives: Other: Mixed fruit juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
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
Measured: 2 hours
Secondary outcomes (2)
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.
Measured: 2 hours
Blood pressure
Useful change in systolic and diastolic blood pressure 2 hours post-consumption of tested beverages
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Sep 2023
- Primary completion15 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Potential Abnormality of Glucose ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agricultural University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Technology and Agricultural Products
- Responsible party
- Principal investigator, Aimilia Papakonstantinou, Agricultural University of Athens
- Investigators
- Emilia Papakonstantinou, PhD, Principal investigator, Agricultural University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163937
- Sponsor's protocol ID
- HRBD 67/06.09.2023
- Status last verified
- Jun 2024
- First submitted
- 1 Dec 2023
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06163937
- Acronym / sponsor ID
- HRBD 67/06.09.2023
- Keywords
- blood glucose, fruit juice, glycemic index, glycemic load, satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Agricultural University of AthensUniversity, hospital or other
- Collaborators
- Institute of Technology and Agricultural Products
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigated the acute effects of two fruit juices on postprandial glycemic responses and satiety in healthy individuals
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glucose as reference food | Experimental | Other: Glucose as reference foodTen 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. |
| Orange juice | Experimental | Other: Orange juiceTen 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. |
| Mixed fruit juice | Experimental | Other: Mixed fruit juiceTen 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy
- non-smoking
- non-diabetic and normotensive men and women
- body mass index between 18.5 and 25 kg/m2
Key exclusion criteria (7 listed)
- severe chronic disease (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver conditions, endocrine conditions)
- gastrointestinal disorders
- pregnancy
- lactation
- competitive sports
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose as reference foodTen 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. | Other | Glucose as reference food |
| Orange juiceTen 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. | Other | Orange juice |
| Mixed fruit juiceTen 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. | Other | Mixed fruit juice |
Primary outcome
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.
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 secondary outcomes
Subjective appetite ratings
Time frame: 2 hours
Blood pressure
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilia Papakonstantinou, PhD principal investigator
Agricultural University of Athens
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose as reference food, Orange juice and Mixed fruit juice in people with Potential Abnormality of Glucose Tolerance and Appetitive Behavior, run by Agricultural University of Athens at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic index (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.