CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 16 enrolled
Drug / intervention
consumption of glucose solution 1 +4 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06152874
NCT06152874N/ACompleted

The Combined Effect of Gluten Addition and Cell Wall Integrity in Durum Wheat Bread on Glycemic and Insulinemic Response in Vivo.

University of Udine·interventional·Posted Dec 1, 2023·Updated May 9, 2024

In Brief

A clinical study evaluating consumption of glucose solution 1, consumption of glucose solution 2, and 3 other interventions for Glucose Response and 3 related conditions. Completed, enrolled 16 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly

Timeline

N/ACompletedFinished
202420252026
First PostedDec 1, 2023
Enrollment StartSep 19, 2023
Primary CompletionDec 15, 2023
Study CompletionDec 23, 2023
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 2.6 years ago

Interventions

consumption of glucose solution 1other

glucose solution prepared dissolving 55 g of monohydrate glucose powder in 250 mL of water

consumption of glucose solution 2other

glucose solution prepared dissolving 55 g of monohydrate glucose powder in 250 mL of water

consumption of Bread A and oral processingother

bread made with 95% durum wheat fine semolina (\< 400 micrometer) + 5% of gluten + 1.2% of yeast + 1% of salt + 59%of water) (portion corresponding to 50 g available carbohydrates) + 250 mL water

consumption of Bread B and oral processingother

bread made with 80% durum wheat fine semolina (\< 400micrometer) + 20% of gluten+ 1.2% of yeast + 1% of salt + 59%of water (portion corresponding to 50g available carbohydrates) +250 mL water

consumption of Bread C and oral processingother

bread made with 80% durum wheat coarse semolina (\> 500micrometer)+ 20% of gluten+ 1.2% of yeast + 1% of salt + 59%of water (portion corresponding to 50g available carbohydrates) +250 mL water