Potential Abnormality of Glucose ToleranceNCT03331757
Determination of Glycemic Index of Six Greek Honey Grades
A study testing Glucose as reference food, Fir honey and Heather honey in people with Potential Abnormality of Glucose Tolerance and Appetitive Behavior, run by Agricultural University of Athens at 1 site in Greece.
Trial summary
This study determined the glycemic index and glycemic load of six Greek honey varieties Read more about this study
- Who is it for?
- Ages 18 to 50 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, Fir honey and Heather honey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteGreece
- Study dates
- 12 Feb 2017to 2 Sep 2017
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- non-smoking
- individuals with normal body mass index (between 18.5 and 24.9 kg/m2)
Who cannot join
- coronary heart disease
- diabetes mellitus
- kidney disease
- liver conditions
- endocrine conditions
- gastrointestinal disorders
Show all 11Show fewer
- pregnancy
- lactation,
- competitive sports
- alcohol
- drug dependency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Glycemic Index and Glycemic Load of Six Greek Honey Grades
This study determined the glycemic index and glycemic load of six Greek honey varieties
Read the detailed description
This randomized, double-blind, cross-over study investigated the glycemic response to six Greek honey grades differing in floral source and carbohydrate composition. Isoglucidic test meals (50g available carbohydrate) and 50g glucose reference were given to 11 clinically and metabolically healthy, fasting individuals (27±7 years; 9 women; BMI 24±4kg/m2), in random order. GI was calculated using the FAO/WHO method. Capillary blood glucose samples were collected at 0,15,30,45,60,90-and-120min. Salivary insulin samples were collected at 0,60-and-120min. Subjective appetite ratings (hunger, fullness and desire to eat) were assessed by visual analogue scales (VAS, 100mm) at baseline and 120min.
- Being tested
- Glucose as reference food, Fir honey, Heather honey, Citrus honey, Pine honey
- 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
Eleven subjects (male: 2, female: 9) consumed 50g glucose diluted in 300ml water, tested three times, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
Fir honeyOther
Eleven subjects (male: 2, female: 9) consumed 50g available carbohydrates of fir honey diluted in 300ml water, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
Heather honeyOther
Eleven subjects (male: 2, female: 9) consumed 50g available carbohydrates of heather honey diluted in 300ml water, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
Citrus honeyOther
Eleven subjects (male: 2, female: 9) consumed 50g available carbohydrates of citrus honey diluted in 300ml water, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
Pine honeyOther
Eleven subjects (male: 2, female: 9) consumed 50g available carbohydrates of pine honey diluted in 300ml water, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
Thyme honeyOther
Eleven subjects (male: 2, female: 9) consumed 50g available carbohydrates of thyme honey diluted in 300ml water, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
Chestnut honeyOther
Eleven subjects (male: 2, female: 9) consumed 50g available carbohydrates of chestnut honey diluted in 300ml water, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
| Study group | Role | What they receive |
|---|---|---|
| Glucose as reference food | Experimental | Eleven metabolically healthy, normal weight subjects (male: 2, female: 9) after 10-14 hr fast, consumed 50g available carbohydrate from D-glucose, tested three times, in different weeks as reference food along with 300ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first drink. Receives: Other: Glucose as reference food; Other: Fir honey; Other: Heather honey; Other: Citrus honey; Other: Pine honey; Other: Thyme honey; Other: Chestnut honey |
| Fir honey | Experimental | Eleven metabolically healthy, normal weight subjects (male: 2, female: 9) after 10-14 hr fast, consumed 50g available carbohydrate from fir honey, tested once, along with 300ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first drink. Receives: Other: Glucose as reference food; Other: Fir honey; Other: Heather honey; Other: Citrus honey; Other: Pine honey; Other: Thyme honey; Other: Chestnut honey |
| Heather honey | Experimental | Eleven metabolically healthy, normal weight subjects (male: 2, female: 9) after 10-14 hr fast, consumed 50g available carbohydrate from heather honey, tested once, along with 300ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first drink. Receives: Other: Glucose as reference food; Other: Fir honey; Other: Heather honey; Other: Citrus honey; Other: Pine honey; Other: Thyme honey; Other: Chestnut honey |
| Citrus honey | Experimental | Eleven metabolically healthy, normal weight subjects (male: 2, female: 9) after 10-14 hr fast, consumed 50g available carbohydrate from citrus honey, tested once, along with 300ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first drink. Receives: Other: Glucose as reference food; Other: Fir honey; Other: Heather honey; Other: Citrus honey; Other: Pine honey; Other: Thyme honey; Other: Chestnut honey |
| Pine honey | Experimental | Eleven metabolically healthy, normal weight subjects (male: 2, female: 9) after 10-14 hr fast, consumed 50g available carbohydrate from pine honey, tested once, along with 300ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first drink. Receives: Other: Glucose as reference food; Other: Fir honey; Other: Heather honey; Other: Citrus honey; Other: Pine honey; Other: Thyme honey; Other: Chestnut honey |
| Thyme honey | Experimental | Eleven metabolically healthy, normal weight subjects (male: 2, female: 9) after 10-14 hr fast, consumed 50g available carbohydrate from thyme honey, tested once, along with 300ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first drink. Receives: Other: Glucose as reference food; Other: Fir honey; Other: Heather honey; Other: Citrus honey; Other: Pine honey; Other: Thyme honey; Other: Chestnut honey |
| Chestnut honey | Experimental | Eleven metabolically healthy, normal weight subjects (male: 2, female: 9) after 10-14 hr fast, consumed 50g available carbohydrate from chestnut honey, tested once, along with 300ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first drink. Receives: Other: Glucose as reference food; Other: Fir honey; Other: Heather honey; Other: Citrus honey; Other: Pine honey; Other: Thyme honey; Other: Chestnut honey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capillary blood glucose responses
Clinically useful change in capillary blood glucose, defined as the restoration of glucose within normal limits during the 2hr glucose tolerance test.
Measured: 2 hours
Secondary outcomes (1)
Subjective appetite rating
Useful change in subjective appetite using visual analogue scales (VAS, 100 mm, given in the form of booklet, one scale per page) before and 2hr after consumption of six Greek honey grades.
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 posted6 Nov 2017
- Study start12 Feb 2017
- Primary completion12 Apr 2017
- Study completion2 Sep 2017
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
- Model description
- Eleven healthy participants consumed in random order 50g available carbohydrates as glucose (tested three times) and 50g available carbohydrates as fir, chestnut, healther, thyme, pine, citrus, tested once, on separate occasions
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agricultural University of Athens
- Sponsor type
- University, hospital or other
- 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
- NCT03331757
- Sponsor's protocol ID
- 1254
- Status last verified
- Nov 2017
- First submitted
- 31 Oct 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Glycemic Index and Glycemic Load of Six Greek Honey Grades
- ClinicalTrials.gov ID
- NCT03331757
- Acronym / sponsor ID
- 1254
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Agricultural University of AthensUniversity, hospital or other
- Study start
- 12 Feb 2017 (actual)
- Primary completion
- 12 Apr 2017 (actual)
- Study completion
- 2 Sep 2017 (actual)
- First posted
- 6 Nov 2017 (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 determined the glycemic index and glycemic load of six Greek honey varieties
Detailed description
This randomized, double-blind, cross-over study investigated the glycemic response to six Greek honey grades differing in floral source and carbohydrate composition. Isoglucidic test meals (50g available carbohydrate) and 50g glucose reference were given to 11 clinically and metabolically healthy, fasting individuals (27±7 years; 9 women; BMI 24±4kg/m2), in random order. GI was calculated using the FAO/WHO method. Capillary blood glucose samples were collected at 0,15,30,45,60,90-and-120min. Salivary insulin samples were collected at 0,60-and-120min. Subjective appetite ratings (hunger, fullness and desire to eat) were assessed by visual analogue scales (VAS, 100mm) at baseline and 120min.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
- Model description
- Eleven healthy participants consumed in random order 50g available carbohydrates as glucose (tested three times) and 50g available carbohydrates as fir, chestnut, healther, thyme, pine, citrus, tested once, on separate occasions
| Arm | Type | Receives |
|---|---|---|
| Glucose as reference food | Experimental | Other: Glucose as reference food, Other: Fir honey, Other: Heather honey, Other: Citrus honey, Other: Pine honey, Other: Thyme honey, Other: Chestnut honeyEleven metabolically healthy, normal weight subjects (male: 2, female: 9) after 10-14 hr fast, consumed 50g available carbohydrate from D-glucose, tested three times, in different weeks as reference food along with 300ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first drink. |
| Fir honey | Experimental | Other: Glucose as reference food, Other: Fir honey, Other: Heather honey, Other: Citrus honey, Other: Pine honey, Other: Thyme honey, Other: Chestnut honeyEleven metabolically healthy, normal weight subjects (male: 2, female: 9) after 10-14 hr fast, consumed 50g available carbohydrate from fir honey, tested once, along with 300ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first drink. |
| Heather honey | Experimental | Other: Glucose as reference food, Other: Fir honey, Other: Heather honey, Other: Citrus honey, Other: Pine honey, Other: Thyme honey, Other: Chestnut honeyEleven metabolically healthy, normal weight subjects (male: 2, female: 9) after 10-14 hr fast, consumed 50g available carbohydrate from heather honey, tested once, along with 300ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first drink. |
| Citrus honey | Experimental | Other: Glucose as reference food, Other: Fir honey, Other: Heather honey, Other: Citrus honey, Other: Pine honey, Other: Thyme honey, Other: Chestnut honeyEleven metabolically healthy, normal weight subjects (male: 2, female: 9) after 10-14 hr fast, consumed 50g available carbohydrate from citrus honey, tested once, along with 300ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first drink. |
| Pine honey | Experimental | Other: Glucose as reference food, Other: Fir honey, Other: Heather honey, Other: Citrus honey, Other: Pine honey, Other: Thyme honey, Other: Chestnut honeyEleven metabolically healthy, normal weight subjects (male: 2, female: 9) after 10-14 hr fast, consumed 50g available carbohydrate from pine honey, tested once, along with 300ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first drink. |
| Thyme honey | Experimental | Other: Glucose as reference food, Other: Fir honey, Other: Heather honey, Other: Citrus honey, Other: Pine honey, Other: Thyme honey, Other: Chestnut honeyEleven metabolically healthy, normal weight subjects (male: 2, female: 9) after 10-14 hr fast, consumed 50g available carbohydrate from thyme honey, tested once, along with 300ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first drink. |
| Chestnut honey | Experimental | Other: Glucose as reference food, Other: Fir honey, Other: Heather honey, Other: Citrus honey, Other: Pine honey, Other: Thyme honey, Other: Chestnut honeyEleven metabolically healthy, normal weight subjects (male: 2, female: 9) after 10-14 hr fast, consumed 50g available carbohydrate from chestnut honey, tested once, along with 300ml water. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. The first glucose sample was taken exactly 15min after the first drink. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy
- non-smoking
- individuals with normal body mass index (between 18.5 and 24.9 kg/m2)
Key exclusion criteria (11 listed)
- coronary heart disease
- diabetes mellitus
- kidney disease
- liver conditions
- endocrine conditions
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 foodEleven subjects (male: 2, female: 9) consumed 50g glucose diluted in 300ml water, tested three times, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. | Other | Chestnut honey, Citrus honey, Fir honey, Glucose as reference food, Heather honey, Pine honey, Thyme honey |
| Fir honeyEleven subjects (male: 2, female: 9) consumed 50g available carbohydrates of fir honey diluted in 300ml water, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. | Other | Chestnut honey, Citrus honey, Fir honey, Glucose as reference food, Heather honey, Pine honey, Thyme honey |
| Heather honeyEleven subjects (male: 2, female: 9) consumed 50g available carbohydrates of heather honey diluted in 300ml water, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. | Other | Chestnut honey, Citrus honey, Fir honey, Glucose as reference food, Heather honey, Pine honey, Thyme honey |
| Citrus honeyEleven subjects (male: 2, female: 9) consumed 50g available carbohydrates of citrus honey diluted in 300ml water, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. | Other | Chestnut honey, Citrus honey, Fir honey, Glucose as reference food, Heather honey, Pine honey, Thyme honey |
| Pine honeyEleven subjects (male: 2, female: 9) consumed 50g available carbohydrates of pine honey diluted in 300ml water, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. | Other | Chestnut honey, Citrus honey, Fir honey, Glucose as reference food, Heather honey, Pine honey, Thyme honey |
| Thyme honeyEleven subjects (male: 2, female: 9) consumed 50g available carbohydrates of thyme honey diluted in 300ml water, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. | Other | Chestnut honey, Citrus honey, Fir honey, Glucose as reference food, Heather honey, Pine honey, Thyme honey |
| Chestnut honeyEleven subjects (male: 2, female: 9) consumed 50g available carbohydrates of chestnut honey diluted in 300ml water, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min. | Other | Chestnut honey, Citrus honey, Fir honey, Glucose as reference food, Heather honey, Pine honey, Thyme honey |
Primary outcome
Capillary blood glucose responses
Time frame: 2 hours
Clinically useful change in capillary blood glucose, defined as the restoration of glucose within normal limits during the 2hr glucose tolerance test.
1 secondary outcome
Subjective appetite rating
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 6 Nov 2017.
- 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
1 site 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, Fir honey and Heather honey in people with Potential Abnormality of Glucose Tolerance and Appetitive Behavior, run by Agricultural University of Athens at 1 site 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 3 inclusion and 11 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 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Capillary blood glucose responses (time frame: 2 hours). 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 6 Nov 2017.