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Effects of Traditional Greek Meals on Glycemic Responses

Primary Purpose

Potential Abnormality of Glucose Tolerance, Appetitive Behavior

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Glucose as reference food
Lentils and lupins mixed meal
Trahanas with tomato sauce mixed meal
Halva with currants mixed meal
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 focused on measuring blood glucose, lentils, trahanas, halva, glycemic index

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy
  • non-smoking
  • non-diabetic men and women
  • normal body mass index (BMI; between 18.5 and 25 kg/m2)

Exclusion Criteria:

  • severe chronic disease (e.g. coronary heart disease, diabetes mellitus, kidney or 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 Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Glucose as reference food

Lentils and lupins mixed meal

Trahanas with tomato sauce mixed meal

Halva with currants mixed meal

Arm Description

Twelve healthy, normal weight subjects (male: 7, female: 7) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from lentils and lupins, trahanas with tomato sauce and halva with currants, tested once, in different weeks along with 250ml 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 bite of food or drink.

Twelve healthy, normal weight subjects (male: 7, female: 7) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from lentils and lupins, trahanas with tomato sauce and halva with currants, tested once, in different weeks along with 250ml 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 bite of food or drink.

Twelve healthy, normal weight subjects (male: 7, female: 7) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from lentils and lupins, trahanas with tomato sauce and halva with currants, tested once, in different weeks along with 250ml 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 bite of food or drink.

Twelve healthy, normal weight subjects (male: 7, female: 7) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from lentils and lupins, trahanas with tomato sauce and halva with currants, tested once, in different weeks along with 250ml 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 bite of food or drink.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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 120 min. 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.
Blood pressure
Useful change in systolic and diastolic blood pressure before and 2hr after consumption of three mixed meals

Full Information

First Posted
April 1, 2021
Last Updated
April 4, 2021
Sponsor
Agricultural University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT04831268
Brief Title
Effects of Traditional Greek Meals on Glycemic Responses
Official Title
Effects of Traditional Greek Meals: Lentils With Lupino, Trahanas With Tomato Sauce and Halva With Currants on Glycemic Responses: Randomized Clinical Trial in Healthy Humans
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (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
Yes

5. Study Description

Brief Summary
This study investigated the effects of Greek traditional meals in dehydrated form consumed after reconstitution with water on glycemic responses
Detailed Description
This study aimed at 1. to determined the glycemic index and glycemic load of three mixed meals and 2. to investigate the effects of these mixed meals on postprandial glycemic response in healthy subjects

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
Keywords
blood glucose, lentils, trahanas, halva, glycemic index

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover Assignment
Masking
Investigator
Masking Description
Single (Investigator)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glucose as reference food
Arm Type
Experimental
Arm Description
Twelve healthy, normal weight subjects (male: 7, female: 7) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from lentils and lupins, trahanas with tomato sauce and halva with currants, tested once, in different weeks along with 250ml 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 bite of food or drink.
Arm Title
Lentils and lupins mixed meal
Arm Type
Experimental
Arm Description
Twelve healthy, normal weight subjects (male: 7, female: 7) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from lentils and lupins, trahanas with tomato sauce and halva with currants, tested once, in different weeks along with 250ml 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 bite of food or drink.
Arm Title
Trahanas with tomato sauce mixed meal
Arm Type
Experimental
Arm Description
Twelve healthy, normal weight subjects (male: 7, female: 7) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from lentils and lupins, trahanas with tomato sauce and halva with currants, tested once, in different weeks along with 250ml 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 bite of food or drink.
Arm Title
Halva with currants mixed meal
Arm Type
Experimental
Arm Description
Twelve healthy, normal weight subjects (male: 7, female: 7) after 10-14 hr fast, consumed 25g available carbohydrate from D-glucose, three times, in different weeks as reference food along with 250ml water; and 25g available carbohydrates from lentils and lupins, trahanas with tomato sauce and halva with currants, tested once, in different weeks along with 250ml 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 bite of food or drink.
Intervention Type
Other
Intervention Name(s)
Glucose as reference food
Intervention Description
Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g glucose diluted in 250ml water, tested three times, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
Intervention Type
Other
Intervention Name(s)
Lentils and lupins mixed meal
Intervention Description
Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from lentils and lupins mixed meal along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
Intervention Type
Other
Intervention Name(s)
Trahanas with tomato sauce mixed meal
Intervention Description
Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from trahanas with tomato sauce mixed meal along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
Intervention Type
Other
Intervention Name(s)
Halva with currants mixed meal
Intervention Description
Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from halva with currants mixed meal along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
Primary Outcome Measure Information:
Title
Capillary blood glucose responses
Description
Clinically useful change in 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 ratings
Description
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 120 min. 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.
Time Frame
2 hours
Title
Blood pressure
Description
Useful change in systolic and diastolic blood pressure before and 2hr after consumption of three mixed meals
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy non-smoking non-diabetic men and women normal body mass index (BMI; between 18.5 and 25 kg/m2) Exclusion Criteria: severe chronic disease (e.g. coronary heart disease, diabetes mellitus, kidney or liver conditions, endocrine conditions) gastrointestinal disorders pregnancy lactation competitive sports alcohol drug dependency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aimilia Papakonstantinou, PhD
Organizational Affiliation
Agricultural University of Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Agricultural University of Athens
City
Athens
State/Province
Attica
ZIP/Postal Code
11855
Country
Greece

12. IPD Sharing Statement

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Effects of Traditional Greek Meals on Glycemic Responses

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