Potential Abnormality of Glucose ToleranceNCT04858373

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

A study testing Glucose as reference food, Emmer bread from Greek emmer and Emmer bread from Italian emmer in people with Potential Abnormality of Glucose Tolerance and Appetitive Behavior, run by Agricultural University of Athens at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 25 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, Emmer bread from Greek emmer and Emmer bread from Italian emmer
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteGreece
Study dates: 1 Aug 2019to 1 Nov 2019
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 25 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

healthy
non-smoking
non-diabetic men and women
body mass index (BMI) between 18 and 27 kg/m2

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Greece1 site

Agricultural University of Athens
Athens, Attica, 11855

Other trials in Greece

About this study

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

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

Read the 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

Conditions: Potential Abnormality of Glucose Tolerance, Appetitive Behavior
Being tested: Glucose as reference food, Emmer bread from Greek emmer, Emmer bread from Italian emmer, Whole wheat commercial bread
Keywords: blood glucose, emmer bread, glycemic index, glycemic load, blood pressure
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
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 emmerOther
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 emmerOther
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 breadOther
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.

Study groups in NCT04858373
Study group	Role	What they receive
Glucose as reference food	Experimental	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. Receives: Other: Glucose as reference food; Other: Emmer bread from Greek emmer; Other: Emmer bread from Italian emmer; Other: Whole wheat commercial bread
Emmer bread from Greek emmer	Experimental	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. Receives: Other: Glucose as reference food; Other: Emmer bread from Greek emmer; Other: Emmer bread from Italian emmer; Other: Whole wheat commercial bread
Emmer bread from Italian emmer	Experimental	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. Receives: Other: Glucose as reference food; Other: Emmer bread from Greek emmer; Other: Emmer bread from Italian emmer; Other: Whole wheat commercial bread
Whole wheat commercial bread	Experimental	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. Receives: Other: Glucose as reference food; Other: Emmer bread from Greek emmer; Other: Emmer bread from Italian emmer; Other: Whole wheat commercial bread

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 blood glucose, defined as the restoration of glucose within normal limits during the 2hr glucose tolerance test
Measured: 2 hours

Secondary outcomes (2)

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.
Measured: 2 hours
Blood pressure
Useful change in systolic and diastolic blood pressure before and 2hr after consumption of the breads
Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20191 Nov 2019

First posted26 Apr 2021
Study start1 Aug 2019
Primary completion1 Nov 2019
Study completion1 Nov 2019

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: Crossover Assignment
Masking: Single blind
Who is masked: Investigator
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04858373
Sponsor's protocol ID: HRBD 39 12/07/2019
Status last verified: Apr 2021
First submitted: 21 Apr 2021
Last updated: 26 Apr 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04858373
Acronym / sponsor ID: HRBD 39 12/07/2019
Conditions: Potential Abnormality of Glucose Tolerance, Appetitive Behavior
Keywords: blood glucose, emmer bread, glycemic index, glycemic load, blood pressure
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Agricultural University of AthensUniversity, hospital or other
Study start: 1 Aug 2019 (actual)
Primary completion: 1 Nov 2019 (actual)
Study completion: 1 Nov 2019 (actual)
First posted: 26 Apr 2021 (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 characterized emmer seeds, flours, and breads, and investigated the effects of emmer breads on the glycemic response

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 4
Model description: Crossover Assignment

Arm	Type	Receives
Glucose as reference food	Experimental	Other: Glucose as reference food, Other: Emmer bread from Greek emmer, Other: Emmer bread from Italian emmer, Other: Whole wheat commercial breadFourteen 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.
Emmer bread from Greek emmer	Experimental	Other: Glucose as reference food, Other: Emmer bread from Greek emmer, Other: Emmer bread from Italian emmer, Other: Whole wheat commercial breadFourteen 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.
Emmer bread from Italian emmer	Experimental	Other: Glucose as reference food, Other: Emmer bread from Greek emmer, Other: Emmer bread from Italian emmer, Other: Whole wheat commercial breadFourteen 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.
Whole wheat commercial bread	Experimental	Other: Glucose as reference food, Other: Emmer bread from Greek emmer, Other: Emmer bread from Italian emmer, Other: Whole wheat commercial breadFourteen 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.

Who may qualify

Ages: 18 to 25 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

healthy
non-smoking
non-diabetic men and women
body mass index (BMI) between 18 and 27 kg/m2

Key exclusion criteria (7 listed)

severe chronic disease (e.g. coronary heart disease, diabetes mellitus,kidney or liver conditions, endocrine conditions)
gastrointestinal disorders
pregnancy
lactation
competitive sports

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 foodFourteen 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.	Other	Emmer bread from Greek emmer, Emmer bread from Italian emmer, Glucose as reference food, Whole wheat commercial bread
Emmer bread from Greek emmerFourteen 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.	Other	Emmer bread from Greek emmer, Emmer bread from Italian emmer, Glucose as reference food, Whole wheat commercial bread
Emmer bread from Italian emmerFourteen 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.	Other	Emmer bread from Greek emmer, Emmer bread from Italian emmer, Glucose as reference food, Whole wheat commercial bread
Whole wheat commercial breadFourteen 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.	Other	Emmer bread from Greek emmer, Emmer bread from Italian emmer, Glucose as reference food, Whole wheat commercial bread

Primary outcome

Capillary blood glucose responses
Time frame: 2 hours
Clinically useful change in blood glucose, defined as the restoration of glucose within normal limits during the 2hr glucose tolerance test

2 secondary outcomes

Subjective appetite ratings
Time frame: 2 hours
Blood pressure
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 26 Apr 2021.

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.

Aimilia 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?

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 4 inclusion and 7 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 26 Apr 2021. 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?

On the ClinicalTrials.gov record for NCT04858373.

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 26 Apr 2021.