Bread Structure and Postprandial Metabolic Responses

Effects of Less-processed Whole Grain Bread Products (Wheat and Fortified With Legumes) on Postprandial Glucose and Subsequent Metabolic Responses.

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.

Study Overview

• Status: Completed
• Conditions: Postprandial Hyperglycemia
• Intervention / Treatment: Other: Finely milled whole wheat-legume bread; Other: Less processed whole wheat-legume bread; Other: Less processed whole wheat bread; Other: White wheat bread

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attiki
    • Athens, Attiki, Greece, 17671
      • Amalia Yanni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Finely milled whole wheat-legume bread; Treatment with finely milled whole wheat-legume bread.	Other: Finely milled whole wheat-legume bread; The intervention examines the effect of finely milled wheat-legume bread in subjects with normal body weight.
Experimental: Less processed whole wheat-legume bread; Treatment with less processed whole wheat-legume bread.	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.
Experimental: Less processed whole wheat bread; Treatment with of less processed whole wheat bread.	Other: Less processed whole wheat bread; The intervention examines the effect of less processed whole wheat bread in subjects with normal body weight.
Active Comparator: Reference Food (white wheat bread); Treatment with reference food.	Other: White wheat bread; The intervention examines the reference food product in subjects with normal body weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Time points: 0 (before food consumption), 30, 45, 60, 90,120,180 minutes postprandially (4 times in total).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Time points: 0 (before food consumption), 30, 60, 90,120,180 minutes postprandially (4 times in total).

Collaborators and Investigators

• Sponsor: Harokopio University
• Collaborators: National and Kapodistrian University of Athens
• Investigators: Study Chair: Nikolaos Tentolouris, Professor, National and Kapodistrian University of Athens; Study Chair: Vaios Karathanos, Professor, Harokopio University of Athens

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2023
• Primary Completion (Actual): May 15, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: appetite regulation; glycemic control; bread; food structure
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: 513.26-07-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No