Clinical trial NCT03104686: Pasta and Bread Prepared With Durum Wheat Semolina: Effect on Post-prandial Glucose and Insulin Metabolism
Official title: Pasta and Bread Prepared With Durum Wheat Semolina: Effect on Post-prandial Glucose and Insulin Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Lead sponsor: University of Parma
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Carbohydrate-based products can influence the post-prandial glycemic response differently based on their ability to be digested, absorbed and to affect rises in plasma glucose. Pasta is one of the major carbohydrate-rich foods consumed in Italy. Studies from the literature describe a lower glycemic response after the consumption of pasta compared with other wheat-based products, such as bread. Among the factors affecting post-prandial glycemia after consumption of carbohydrate-based products, the technological process represents a central one. In fact, the different technological processes alter the food matrix which can affect the post-prandial metabolism of glucose and insulin differently. Thus, the present study aims at investigating the effect induced by the principal steps of the process of pasta production on the reduction of post-prandial glycemic and insulinemic responses.

Detailed description: The different glycemic responses after the consumption of carbohydrate-based products are associated with different rates of digestion and absorption of the carbohydrates in the human body. Therefore, food products rich in carbohydrates can be classified based on their ability to be digested, absorbed and to affect post-prandial glycemia. Epidemiological studies suggest that following a diet including carbohydrate-based foods inducing a low and slow glycemic response is associated with reduced risk to develop some non-communicable diseases (such as type 2 diabetes and cardiovascular disease), to control inflammatory status, which is the trigger of several pathologies, and to reduce fasting insulin. Depending on the food composition, a low glycemic response is not always associated with a low plasma insulin concentration. For instance, high protein or lipid concentrations in the food matrix have been demonstrated to induce low post-prandial glycemic responses, but not a reduction in insulin secretion. Avoiding a high insulin post-prandial response after consumption of foods represents a preventive factor against the risk of overweight and hyperlipidemia, type 2 diabetes, and cancer. Therefore, the evaluation of both glycemic and insulinemic post-prandial response curves is necessary in order to demonstrate the true beneficial effect of the consumption of low glycemic index foods. Among several factors which can influence the post-prandial glycemic and insulinemic responses (such as macronutrient composition and the cooking process), the technological aspects through which the foods are produced represent an important one. Several studies reported a low glycemic response after the consumption of pasta compared with bread, and this is due to the technological structures characterizing the two matrices. Pasta is one of the major sources of carbohydrates consumed in Italy. Therefore, the aim of the present study is to investigate the effect of pasta and bread on the plasma response of glucose and insulin, as well as c-peptide in order to clearly discriminate the different biological effect induced by the technological process in the production of pasta, compared to foods beginning with the same ingredients. Moreover, the study aims to create a solid basis for future studies for evaluating the effect of pasta consumption, as the main source of carbohydrates, in a context of a balanced diet, for maintaining health.

Eligibility criteria: Inclusion Criteria:

* healthy male and female

Exclusion Criteria:

* BMI\>30kg/m2
* celiac disease
* metabolic disorders (diabetes, hypertension, dislipidemia, glucidic intolerance)
* chronic drug therapies for any pathologies (including psychiatric diseases)
* intense physical activity
* dietary supplements affecting the metabolism
* anemia

Primary outcomes:
measure: incremental area under the curve for blood glucose
timeFrame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
measure: incremental area under the curve for plasma insulin
timeFrame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
Secondary outcomes:
measure: post-prandial c-peptide plasma concentration
timeFrame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
Other outcomes:
Locations:
city: Parma
country: Italy
facility: Department of Food Science, University of Parma
Study officials:
affiliation: Department of Food Science, University of Parma
name: Francesca Scazzina, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Food Science, University of Parma
name: Furio Brighenti, PhD
role: STUDY_DIRECTOR
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