Glycemic Index Clinical Trial
Official title:
The Combined Effect of Gluten Addition and Cell Wall Integrity in Durum Wheat Bread on Glycemic and Insulinemic Response in Vivo.
Verified date | May 2024 |
Source | University of Udine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | December 23, 2023 |
Est. primary completion date | December 15, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Age between 18-50 years old; - Have good general health; - Have normal smell and taste functions; - Have a normal body mass index (BMI 18.5-24.9 kg/m2) (based on self-reported weight and height). Exclusion Criteria: - Have dental braces or a piercing in or around the mouth (except removable piercings); - Use medications known to affect glucose tolerance and influence digestion and absorption of nutrients (excluding oral contraceptives) - stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins, and mineral supplements or drugs to treat hypertension are acceptable. - Have a known history of diabetes mellitus or the use of antihyperglycemic drugs or insulin to treat diabetes and related conditions; - Have a major medical or surgical event requiring hospitalization within the preceding 3 months; - Have any food allergy or intolerance for gluten; - Being pregnant or lactating (self-reported); - Use medication that may affect the function of taste, smell, mastication, and salivation; |
Country | Name | City | State |
---|---|---|---|
Italy | Department of Agricultural, Food, Environmental and Animal Sciences, University of Udine, | Udine |
Lead Sponsor | Collaborator |
---|---|
University of Udine | Wageningen University and Research |
Italy,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-prandial glycemic response | Post-prandial glycemic response (incremental area under the curve) | Time 2 hours (sampling at 0 -fasting-, 15, 30, 45, 60, 90 and 120 minutes) | |
Secondary | Maximum peak for glucose | maximum value of postprandial glucose | Time 2 hours (sampling at 0 -fasting-, 15, 30, 45, 60, 90 and 120 minutes) | |
Secondary | Maximum peak for insulin | maximum value of postprandial insulin | Time 2 hours (sampling at 0 -fasting-, 15, 30, 45, 60, 90 and 120 minutes) | |
Secondary | Satiety using a 10 cm Visual Analogue Scale | Differences in subject-rated satiety using a Visual Analogue Scale consist of a 10 cm line with two endpoints representing 0 ('no satisfied') and 10 ('fully satisfied'). Higher scores mean a better outcome. The incremental area under the curve will be used to check differences over time. | Time 2 hours (before the meal and after the meal at 30, 60 and 120 minutes) | |
Secondary | Gastrointestinal symptoms using a questionnaire with symptoms rated using a 10 cm Visual Analogue Scale | Differences in subject-rated gastrointestinal symptoms using a Visual Analogue Scale consist of a 10 cm line with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Higher scores mean a worse outcome. The incremental area under the curve will be used to check differences over time. | Time 2 hours (before the meal and after the meal at 30, 60 and 120 minutes) | |
Secondary | Post-prandial insulinemic response | Post-prandial insulinemic response (incremental area under the curve) | Time 2 hours (sampling at 0 -fasting-, 15, 30, 45, 60, 90 and 120 minutes) | |
Secondary | Number of chews | The number of chews extracted from the video recorded during bread consumption. | Time 5 minutes performed after 2.30 hours of the consumption of samples for the determination of glycemic and insulinemic curves | |
Secondary | Number of swallows | The number of swallows extracted from the video recorded during bread consumption | Time 5 mininutes performed after 2.30 hours of the consumption of samples for the determination of glycemic and insulinemic curves | |
Secondary | Eating duration | Eating duration extracted from the video recorded during bread consumption | Time 5 minutes performed after 2.30 hours of the consumption of samples for the determination of glycemic and insulinemic curves | |
Secondary | Saliva content in food bolus | The amount of saliva that is incorporated in the food bolus during chewing | Time 5 minutes performed after 2.30 hours of the consumption of samples for the determination of glycemic and insulinemic curves | |
Secondary | Particle size distribution of bolus | The particle size distribution of the bolus, after chewing and spitting in a container, anlyzed with images analysis | Time 5 minutes performed after 2.30 hours of the consumption of samples for the determination of glycemic and insulinemic curves | |
Secondary | Reducing sugar produced in bolus after mastication at time 0 | The amount of reducing sugar produced by alpha-amylase in the bolus immediately after it is spitted in a specific container | Time 10 minutes performed after 2.30 hours of the consumption of samples for the determination of glycemic and insulinemic curves | |
Secondary | Reducing sugar produced in bolus after mastication at time 15 | The amount of reducing sugar produced by alpha-amylase in the bolus after it is spitted in a specific container and incubated for 15 minutes | Time 25 min performed after 2.30 h of the consumption of samples for the determination of glycemic and insulinemic curves |
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