Bread Structure and Postprandial Metabolic Responses

Postprandial Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05691686
• Other study ID #: 513.26-07-2021
• Status: Completed
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: January 2023
• Source: Harokopio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 31, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperglycemia
• Postprandial Hyperglycemia

Intervention

Other:
• Finely milled whole wheat-legume bread
The intervention examines the effect of finely milled wheat-legume bread in subjects with normal body weight.
• Less processed whole wheat-legume bread
The intervention examines the effect of less processed whole wheat-legume bread in subjects with normal body weight.
• Less processed whole wheat bread
The intervention examines the effect of less processed whole wheat bread in subjects with normal body weight.
• White wheat bread
The intervention examines the reference food product in subjects with normal body weight.

Locations

Country	Name	City	State
Greece	Amalia Yanni	Athens	Attiki

Sponsors (2)

Lead Sponsor	Collaborator
Harokopio University	National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).