Bread Structure and Postprandial Metabolic Responses

NCT ID: NCT05691686

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-16
• Study Completion Date: 2023-10-31

Brief Summary

The structural properties of bread are considered one of the most important factors that can affect its digestibility, glucose homeostasis and postprandial metabolic responses. The purpose of this study is to examine the effects of consumption of less processed whole grain bread products (wheat and fortified with legumes) in comparison with finely milled whole grain bread products on postprandial glycaemic response and appetite regulation.

Detailed Description

Postprandial glucose response caused by bread products of different degree of processing, as well as their appetite regulating properties will be evaluated. In the intervention there are totally four samples, the reference (white wheat bread), the less processed whole wheat bread, the whole wheat bread fortified with finely milled legumes (chickpeas), the whole wheat bread fortified with less processed legumes (chickpeas). The volunteers that will be enrolled in the study should be apparently healthy subjects (women and men) with normal body weight. Certain effects related to the structure of the different products on glycemic and insulinemic responses, subjective appetite ratings and other parameters will be examined.

Conditions

Postprandial Hyperglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Finely milled whole wheat-legume bread

Treatment with finely milled whole wheat-legume bread.

Group Type: EXPERIMENTAL

Finely milled whole wheat-legume bread

Intervention Type: OTHER

The intervention examines the effect of finely milled wheat-legume bread in subjects with normal body weight.

Less processed whole wheat-legume bread

Treatment with less processed whole wheat-legume bread.

Group Type: EXPERIMENTAL

Less processed whole wheat-legume bread

Intervention Type: OTHER

The intervention examines the effect of less processed whole wheat-legume bread in subjects with normal body weight.

Less processed whole wheat bread

Treatment with of less processed whole wheat bread.

Group Type: EXPERIMENTAL

Less processed whole wheat bread

Intervention Type: OTHER

The intervention examines the effect of less processed whole wheat bread in subjects with normal body weight.

Reference Food (white wheat bread)

Treatment with reference food.

Group Type: ACTIVE_COMPARATOR

White wheat bread

Intervention Type: OTHER

The intervention examines the reference food product in subjects with normal body weight.

Interventions

Finely milled whole wheat-legume bread

The intervention examines the effect of finely milled wheat-legume bread in subjects with normal body weight.

Intervention Type: OTHER

Less processed whole wheat-legume bread

The intervention examines the effect of less processed whole wheat-legume bread in subjects with normal body weight.

Intervention Type: OTHER

Less processed whole wheat bread

The intervention examines the effect of less processed whole wheat bread in subjects with normal body weight.

Intervention Type: OTHER

White wheat bread

The intervention examines the reference food product in subjects with normal body weight.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• normal exercise and dietary habbits
• weight stable for at least 3 months before enrollment

Exclusion Criteria

• pregnancy and lactation
• diabetes
• chronic medical illness
• regular intense exercise (>5 hrs/week)
• alcohol consumption >2 drinks/day

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National and Kapodistrian University of Athens

OTHER

Sponsor Role: collaborator

Harokopio University

OTHER

Sponsor Role: lead

Responsible Party

Amalia Yanni

Research and Teaching Associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nikolaos Tentolouris, Professor

Role: STUDY_CHAIR

National and Kapodistrian University of Athens

Vaios Karathanos, Professor

Role: STUDY_CHAIR

Harokopio University of Athens

Locations

Amalia Yanni

Athens, Attica, Greece

Countries

Greece

Other Identifiers

513.26-07-2021

Identifier Type: -

Identifier Source: org_study_id