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

NCT ID: NCT04858373

Last Updated: 2021-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2019-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study characterized emmer seeds, flours, and breads, and investigated the effects of emmer breads on the glycemic response

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Potential Abnormality of Glucose Tolerance Appetitive Behavior

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover Assignment
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators
Single (Investigator)

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Glucose as reference food

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.

Group Type EXPERIMENTAL

Glucose as reference food

Intervention Type OTHER

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.

Emmer bread from Greek emmer

Intervention Type OTHER

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.

Emmer bread from Italian emmer

Intervention Type OTHER

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.

Whole wheat commercial bread

Intervention Type OTHER

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.

Emmer bread from Greek emmer

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.

Group Type EXPERIMENTAL

Glucose as reference food

Intervention Type OTHER

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.

Emmer bread from Greek emmer

Intervention Type OTHER

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.

Emmer bread from Italian emmer

Intervention Type OTHER

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.

Whole wheat commercial bread

Intervention Type OTHER

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.

Emmer bread from Italian emmer

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.

Group Type EXPERIMENTAL

Glucose as reference food

Intervention Type OTHER

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.

Emmer bread from Greek emmer

Intervention Type OTHER

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.

Emmer bread from Italian emmer

Intervention Type OTHER

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.

Whole wheat commercial bread

Intervention Type OTHER

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.

Whole wheat commercial bread

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.

Group Type EXPERIMENTAL

Glucose as reference food

Intervention Type OTHER

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.

Emmer bread from Greek emmer

Intervention Type OTHER

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.

Emmer bread from Italian emmer

Intervention Type OTHER

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.

Whole wheat commercial bread

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Glucose as reference food

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

Emmer bread from Greek emmer

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

Emmer bread from Italian emmer

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

Whole wheat commercial bread

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Agricultural University of Athens

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aimilia Papakonstantinou

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Aimilia Papakonstantinou, PhD

Role: PRINCIPAL_INVESTIGATOR

Agricultural University of Athens

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Agricultural University of Athens

Athens, Attica, Greece

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Greece

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HRBD 39 12/07/2019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.