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Completed

NCT Number: NCT03104686

Pasta and Bread Prepared With Durum Wheat Semolina: Effect on Post-prandial Glucose and Insulin Metabolism

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Food Science, University of Parma

Parma, 43125, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Short pasta (dry)

Other

50g available carbohydrate of penne pasta

Other names: Penne

Long pasta (dry)

Other

50g available carbohydrate of spaghetti pasta

Other names: Spaghetti

Bread

Other

50g available carbohydrate of bread

Glucose

Other

50g available carbohydrate of glucose monohydrate

Primary outcomes

  1. incremental area under the curve for blood glucose

    Time frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)

    postprandial response for blood glucose (IAUC)

  2. incremental area under the curve for plasma insulin

    Time frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)

    postprandial response for plasma insulin (IAUC)

Secondary outcomes

  1. post-prandial c-peptide plasma concentration

    Time frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)

    postprandial response for plasma c-peptide (IAUC)

Sponsors and collaborators

Lead sponsor

University of Parma

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 7, 2017
Registry last updated
Sep 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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