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Bread Structure and Postprandial Metabolic Responses

Primary Purpose

Postprandial Hyperglycemia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Finely milled whole wheat-legume bread
Less processed whole wheat-legume bread
Less processed whole wheat bread
White wheat bread
Sponsored by
Harokopio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postprandial Hyperglycemia focused on measuring bread, food structure, glycemic control, appetite regulation

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Amalia Yanni

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Finely milled whole wheat-legume bread

Less processed whole wheat-legume bread

Less processed whole wheat bread

Reference Food (white wheat bread)

Arm Description

Treatment with finely milled whole wheat-legume bread.

Treatment with less processed whole wheat-legume bread.

Treatment with of less processed whole wheat bread.

Treatment with reference food.

Outcomes

Primary Outcome Measures

Change in glucose incremental area under the curve (iAUC) after consumption of the breads compared to the iAUC after consumption of the reference food.
Blood glucose concentration will be measured for each participant before and after the test foods, with blood samples being collected at specific time points: 0 (before food consumption), 30, 45, 60, 90, 120, 180 minutes postprandially for each food.

Secondary Outcome Measures

Subjective appetite ratings
Subjective evaluation of hunger, satiety, and desire to eat with Visual Analogue Scales, before the consumption and 30, 60, 90, 120, 180 minutes after (0-100 mm with 0 indicating no hunger or perceived ability to consume food/no satiety or no fullness). Difference in perception of these parameters will be measured and compared between the experimental condition and the control condition.

Full Information

First Posted
December 22, 2022
Last Updated
September 26, 2023
Sponsor
Harokopio University
Collaborators
National and Kapodistrian University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT05691686
Brief Title
Bread Structure and Postprandial Metabolic Responses
Official Title
Effects of Less-processed Whole Grain Bread Products (Wheat and Fortified With Legumes) on Postprandial Glucose and Subsequent Metabolic Responses.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
May 15, 2023 (Actual)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harokopio University
Collaborators
National and Kapodistrian 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprandial Hyperglycemia
Keywords
bread, food structure, glycemic control, appetite regulation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Finely milled whole wheat-legume bread
Arm Type
Experimental
Arm Description
Treatment with finely milled whole wheat-legume bread.
Arm Title
Less processed whole wheat-legume bread
Arm Type
Experimental
Arm Description
Treatment with less processed whole wheat-legume bread.
Arm Title
Less processed whole wheat bread
Arm Type
Experimental
Arm Description
Treatment with of less processed whole wheat bread.
Arm Title
Reference Food (white wheat bread)
Arm Type
Active Comparator
Arm Description
Treatment with reference food.
Intervention Type
Other
Intervention Name(s)
Finely milled whole wheat-legume bread
Intervention Description
The intervention examines the effect of finely milled wheat-legume bread in subjects with normal body weight.
Intervention Type
Other
Intervention Name(s)
Less processed whole wheat-legume bread
Intervention Description
The intervention examines the effect of less processed whole wheat-legume bread in subjects with normal body weight.
Intervention Type
Other
Intervention Name(s)
Less processed whole wheat bread
Intervention Description
The intervention examines the effect of less processed whole wheat bread in subjects with normal body weight.
Intervention Type
Other
Intervention Name(s)
White wheat bread
Intervention Description
The intervention examines the reference food product in subjects with normal body weight.
Primary Outcome Measure Information:
Title
Change in glucose incremental area under the curve (iAUC) after consumption of the breads compared to the iAUC after consumption of the reference food.
Description
Blood glucose concentration will be measured for each participant before and after the test foods, with blood samples being collected at specific time points: 0 (before food consumption), 30, 45, 60, 90, 120, 180 minutes postprandially for each food.
Time Frame
Time points: 0 (before food consumption), 30, 45, 60, 90,120,180 minutes postprandially (4 times in total).
Secondary Outcome Measure Information:
Title
Subjective appetite ratings
Description
Subjective evaluation of hunger, satiety, and desire to eat with Visual Analogue Scales, before the consumption and 30, 60, 90, 120, 180 minutes after (0-100 mm with 0 indicating no hunger or perceived ability to consume food/no satiety or no fullness). Difference in perception of these parameters will be measured and compared between the experimental condition and the control condition.
Time Frame
Time points: 0 (before food consumption), 30, 60, 90,120,180 minutes postprandially (4 times in total).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikolaos Tentolouris, Professor
Organizational Affiliation
National and Kapodistrian University of Athens
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Vaios Karathanos, Professor
Organizational Affiliation
Harokopio University of Athens
Official's Role
Study Chair
Facility Information:
Facility Name
Amalia Yanni
City
Athens
State/Province
Attiki
ZIP/Postal Code
17671
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No

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Bread Structure and Postprandial Metabolic Responses

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