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

NCT04858373 | Completed DMC

• 1 other identifier: HRBD 39 12/07/2019
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Potential Abnormality of Glucose Tolerance; Appetitive Behavior

Keywords

blood glucose; emmer bread; glycemic index; glycemic load; blood pressure

Outcome Measures

Primary Outcomes (1)

• 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

  2 hours

Secondary Outcomes (2)

• Subjective appetite ratings

  2 hours

• Blood pressure

  2 hours

Study Arms (4)

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.

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.

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.

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.

Other: Glucose as reference food; Other: Emmer bread from Greek emmer; Other: Emmer bread from Italian emmer; Other: Whole wheat commercial bread

Interventions

Glucose as reference food 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; Emmer bread from Italian emmer; Glucose as reference food; Whole wheat commercial bread

Emmer bread from Greek emmer 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 Greek emmer; Emmer bread from Italian emmer; Glucose as reference food; Whole wheat commercial bread

Emmer bread from Italian emmer 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.

Emmer bread from Greek emmer; Emmer bread from Italian emmer; Glucose as reference food; Whole wheat commercial bread

Whole wheat commercial bread 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; Emmer bread from Italian emmer; Glucose as reference food; Whole wheat commercial bread

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Agricultural University of Athens: lead

Study Sites (1)

Agricultural University of Athens

Athens, Attica, 11855, Greece

Location

MeSH Terms

Conditions

Appetitive Behavior

Interventions

Glucose

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Aimilia Papakonstantinou, PhD

  Agricultural University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single (Investigator)
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Crossover Assignment

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 26, 2021
• Study Start: August 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: April 26, 2021

Record last verified: 2021-04

Locations

GR (1)