NCT06152874

Glycemic and Insulinemic Response of Durum Wheat Bread

Completed NA Last updated 9 May 2024

What this trial tests

NA trial testing consumption of glucose solution 1 in Glucose Response in 16 participants. Completed in 23 December 2023.

Timeline

19 September 2023

Primary endpoint
15 December 2023

23 December 2023

Quick facts

Lead sponsor	University of Udine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	basic science
Enrollment	16
Start date	19 September 2023
Primary completion	15 December 2023
Estimated completion	23 December 2023
Sites	1 location across Italy

Drugs / interventions tested

• consumption of glucose solution 1
• consumption of glucose solution 2
• consumption of Bread A and oral processing
• consumption of Bread B and oral processing
• consumption of Bread C and oral processing

Conditions studied

• Glucose Response — all drugs for Glucose Response →
• Glycemic Index — all drugs for Glycemic Index →
• Insulin Response — all drugs for Insulin Response →
• Oral Processing — all drugs for Oral Processing →

Sponsor

University of Udine

Who can join

Adults 18 to 50, any sex, with Glucose Response or Glycemic Index. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In the last decades, the consumption of energy-dense diets, primarily consisting of highly digestible starchy foods like bread, along with a global increase in obesity rates and a sedentary lifestyle, has emerged as the main contributors to the development of non-communicable diseases such as cardiovascular diseases (CVD) and diabetes type 2. Therefore, there is a need to reduce the starch digestibility of bakery products, and in turn their glycemic index, with a specific emphasis on wheat bread. Several strategies have been used to decrease the glycemic index and insulin response of bread; however, most of these techniques have a detrimental effect on the texture, volume, taste, and color of bread, limiting the consumer's acceptability. Preservation of the native microstructure (cell wall integrity) and employing processing techniques to create a macrostructure (protein network and food matrix) can be used to influence the product structure and therefore how the product is chewed (oral processing), and how these factors can affect carbohydrate digestion and glycemic response. The aim of this study was to examine the effect of different textural characteristics of bread on oral processing in relation to the glycemic and insulin response of the three breads. In the present study, a total of 16 healthy volunteers will be recruited, and if eligible (they need to meet the inclusion and exclusion criteria), they will attend an oral processing test on three breads, a test to measure the glycemic index (ISO) and insulin response.

The bread sample composition will be as follows:

Bread A is made with 95% durum wheat fine semolina (\< 400 micrometer) + 5% gluten+ 1.2% yeast + 1% salt + 59% water Bread B is made with 80% durum wheat fine semolina (\< 400 micrometer) + 20% gluten+ 1.2% yeast + 1% salt + 59 % water Bread C is made with 80% durum wheat coarse semolina (\> 500 micrometer) + 20% gluten+ 1.2% yeast + 1% salt + 59 % water.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The combined effect of gluten addition and semolina cell wall integrity reduces the oral sugar release and the insulinemic response to bread in healthy volunteers.
   Tagliasco M, Capuano E, Dall'Asta M, Renzetti S, et al · · 2024 · cited 1× · PMID 39546030 · DOI 10.1007/s00394-024-03517-5