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Characterizing Emmer Seeds and Flours, and Determining the Glycemic Effects of Emmer Breads

Primary Purpose

Potential Abnormality of Glucose Tolerance, Appetitive Behavior

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Glucose as reference food
Emmer bread from Greek emmer
Emmer bread from Italian emmer
Whole wheat commercial bread
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, emmer bread, glycemic index, glycemic load, blood pressure

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy
  • non-smoking
  • non-diabetic men and women
  • body mass index (BMI) between 18 and 27 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

Emmer bread from Greek emmer

Emmer bread from Italian emmer

Whole wheat commercial bread

Arm Description

Fourteen healthy, normal weight subjects (male: 6, female: 8) after 12hr fast, consumed 50g available carbohydrates from D-glucose, three times, in different visits as reference food along with 300ml water; and 50g available carbohydrates from emmer bread from Greek emmer seeds, emmer bread from Italian emmer seeds, and whole wheat commercial soft bread, tested once, in different visits. there was a washout period of 2 days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose sample was taken exactly 15min after the first bite of food or drink.

Fourteen healthy, normal weight subjects (male: 6, female: 8) after 12hr fast, consumed 50g available carbohydrates from D-glucose, three times, in different visits as reference food along with 300ml water; and 50g available carbohydrates from emmer bread from Greek emmer seeds, emmer bread from Italian emmer seeds, and whole wheat commercial soft bread, tested once, in different visits. there was a washout period of 2 days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose sample was taken exactly 15min after the first bite of food or drink.

Fourteen healthy, normal weight subjects (male: 6, female: 8) after 12hr fast, consumed 50g available carbohydrates from D-glucose, three times, in different visits as reference food along with 300ml water; and 50g available carbohydrates from emmer bread from Greek emmer seeds, emmer bread from Italian emmer seeds, and whole wheat commercial soft bread, tested once, in different visits. there was a washout period of 2 days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose sample was taken exactly 15min after the first bite of food or drink.

Fourteen healthy, normal weight subjects (male: 6, female: 8) after 12hr fast, consumed 50g available carbohydrates from D-glucose, three times, in different visits as reference food along with 300ml water; and 50g available carbohydrates from emmer bread from Greek emmer seeds, emmer bread from Italian emmer seeds, and whole wheat commercial soft bread, tested once, in different visits. there was a washout period of 2 days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. 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 the breads

Full Information

First Posted
April 21, 2021
Last Updated
April 21, 2021
Sponsor
Agricultural University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT04858373
Brief Title
Characterizing Emmer Seeds and Flours, and Determining the Glycemic Effects of Emmer Breads
Official Title
Characterizing the Technological Properties of Emmer Seeds, Flour, and Bread; and Determining the Effect of Emmer Breads on Glycemic Responses in Healthy Humans
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 1, 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 characterized emmer seeds, flours, and breads, and investigated the effects of emmer breads on the glycemic response
Detailed Description
This study aimed to 1. describe the technological characteristics of emmer seeds, flours, and breads, 2. determine the glycemic index and glycemic load of two emmer breads, and 3. to investigate the effects of these breads 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, emmer bread, glycemic index, glycemic load, blood pressure

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
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glucose as reference food
Arm Type
Experimental
Arm Description
Fourteen healthy, normal weight subjects (male: 6, female: 8) after 12hr fast, consumed 50g available carbohydrates from D-glucose, three times, in different visits as reference food along with 300ml water; and 50g available carbohydrates from emmer bread from Greek emmer seeds, emmer bread from Italian emmer seeds, and whole wheat commercial soft bread, tested once, in different visits. there was a washout period of 2 days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Arm Title
Emmer bread from Greek emmer
Arm Type
Experimental
Arm Description
Fourteen healthy, normal weight subjects (male: 6, female: 8) after 12hr fast, consumed 50g available carbohydrates from D-glucose, three times, in different visits as reference food along with 300ml water; and 50g available carbohydrates from emmer bread from Greek emmer seeds, emmer bread from Italian emmer seeds, and whole wheat commercial soft bread, tested once, in different visits. there was a washout period of 2 days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Arm Title
Emmer bread from Italian emmer
Arm Type
Experimental
Arm Description
Fourteen healthy, normal weight subjects (male: 6, female: 8) after 12hr fast, consumed 50g available carbohydrates from D-glucose, three times, in different visits as reference food along with 300ml water; and 50g available carbohydrates from emmer bread from Greek emmer seeds, emmer bread from Italian emmer seeds, and whole wheat commercial soft bread, tested once, in different visits. there was a washout period of 2 days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. The first glucose sample was taken exactly 15min after the first bite of food or drink.
Arm Title
Whole wheat commercial bread
Arm Type
Experimental
Arm Description
Fourteen healthy, normal weight subjects (male: 6, female: 8) after 12hr fast, consumed 50g available carbohydrates from D-glucose, three times, in different visits as reference food along with 300ml water; and 50g available carbohydrates from emmer bread from Greek emmer seeds, emmer bread from Italian emmer seeds, and whole wheat commercial soft bread, tested once, in different visits. there was a washout period of 2 days between visits. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min after food consumption. 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
Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, 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 120min.
Intervention Type
Other
Intervention Name(s)
Emmer bread from Greek emmer
Intervention Description
Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g available carbohydrates from Greek emmer bread, tested once, in different visits, 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)
Emmer bread from Italian emmer
Intervention Description
Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g available carbohydrates from Italian emmer bread, tested once, in different visits, 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)
Whole wheat commercial bread
Intervention Description
Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g available carbohydrates from whole wheat commercial bread, tested once, in different visits, 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 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 the breads
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy non-smoking non-diabetic men and women body mass index (BMI) between 18 and 27 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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Characterizing Emmer Seeds and Flours, and Determining the Glycemic Effects of Emmer Breads

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