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Determination of Glycemic Index of Six Greek Honey Grades

Primary Purpose

Potential Abnormality of Glucose Tolerance, Appetitive Behavior

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Glucose as reference food
Fir honey
Heather honey
Citrus honey
Pine honey
Thyme honey
Chestnut honey
Sponsored by
Agricultural University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Potential Abnormality of Glucose Tolerance

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy
  • non-smoking
  • individuals with normal body mass index (between 18.5 and 24.9 kg/m2)

Exclusion Criteria:

  • coronary heart disease
  • diabetes mellitus
  • kidney disease
  • liver conditions
  • endocrine conditions
  • gastrointestinal disorders
  • pregnancy
  • lactation,
  • competitive sports
  • alcohol
  • drug dependency

Sites / Locations

  • Agricultural University of Athens

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Glucose as reference food

Fir honey

Heather honey

Citrus honey

Pine honey

Thyme honey

Chestnut honey

Arm Description

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 31, 2017
Last Updated
November 1, 2017
Sponsor
Agricultural University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT03331757
Brief Title
Determination of Glycemic Index of Six Greek Honey Grades
Official Title
Determination of the Glycemic Index and Glycemic Load of Six Greek Honey Grades
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 12, 2017 (Actual)
Primary Completion Date
April 12, 2017 (Actual)
Study Completion Date
September 2, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Agricultural University of Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Potential Abnormality of Glucose Tolerance, Appetitive Behavior

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantInvestigator
Masking Description
Participants were assigned to the interventions using a sequence of random numbers extracted from computer software. A researcher not involved with the collection and the analysis of the scientific data, was responsible for the randomization of the volunteers to the intervention days examining the test foods. All test meals (glucose and honeys) were diluted in 300ml water and were served in dark paper cups covered with a lid in order to achieve double blind conditions.
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glucose as reference food
Arm Type
Experimental
Arm Description
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.
Arm Title
Fir honey
Arm Type
Experimental
Arm Description
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.
Arm Title
Heather honey
Arm Type
Experimental
Arm Description
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.
Arm Title
Citrus honey
Arm Type
Experimental
Arm Description
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.
Arm Title
Pine honey
Arm Type
Experimental
Arm Description
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.
Arm Title
Thyme honey
Arm Type
Experimental
Arm Description
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.
Arm Title
Chestnut honey
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Glucose as reference food
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Fir honey
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Heather honey
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Citrus honey
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pine honey
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Thyme honey
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Chestnut honey
Intervention Description
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.
Primary Outcome Measure Information:
Title
Capillary blood glucose responses
Description
Clinically useful change in capillary blood glucose, defined as the restoration of glucose within normal limits during the 2hr glucose tolerance test.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Subjective appetite rating
Description
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.
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy non-smoking individuals with normal body mass index (between 18.5 and 24.9 kg/m2) Exclusion Criteria: coronary heart disease diabetes mellitus kidney disease liver conditions endocrine conditions gastrointestinal disorders pregnancy lactation, competitive sports alcohol drug dependency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilia Papakonstantinou, PhD
Organizational Affiliation
Agricultural University of Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Agricultural University of Athens
City
Athens
ZIP/Postal Code
11855
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No

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Determination of Glycemic Index of Six Greek Honey Grades

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