Bread Structure and Postprandial Metabolic Responses

NCT05691686 | Completed DMC

• 1 other identifier: 513.26-07-2021
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Postprandial Hyperglycemia

Keywords

bread; food structure; glycemic control; appetite regulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Subjective appetite ratings

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

Study Arms (4)

Finely milled whole wheat-legume bread

EXPERIMENTAL

Treatment with finely milled whole wheat-legume bread.

Other: Finely milled whole wheat-legume bread

Less processed whole wheat-legume bread

EXPERIMENTAL

Treatment with less processed whole wheat-legume bread.

Other: Less processed whole wheat-legume bread

Less processed whole wheat bread

EXPERIMENTAL

Treatment with of less processed whole wheat bread.

Other: Less processed whole wheat bread

Reference Food (white wheat bread)

ACTIVE COMPARATOR

Treatment with reference food.

Other: White wheat bread

Interventions

Finely milled whole wheat-legume bread OTHER

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

Finely milled whole wheat-legume bread

Less processed whole wheat-legume bread OTHER

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

Less processed whole wheat-legume bread

Less processed whole wheat bread OTHER

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

Less processed whole wheat bread

White wheat bread OTHER

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

Reference Food (white wheat bread)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Harokopio University: lead
• National and Kapodistrian University of Athens: collaborator

Study Sites (1)

Amalia Yanni

Athens, Attica, 17671, Greece

Location

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Nikolaos Tentolouris, Professor

  National and Kapodistrian University of Athens

  STUDY CHAIR

• Vaios Karathanos, Professor

  Harokopio University of Athens

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research and Teaching Associate

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 20, 2023
• Study Start: January 16, 2023
• Primary Completion: May 15, 2023
• Study Completion: October 31, 2023
• Last Updated: March 5, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)