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Trial record 63 of 1012 for:    Area Under Curve AND insulin

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

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ClinicalTrials.gov Identifier: NCT03098017
Recruitment Status : Completed
First Posted : March 31, 2017
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Francesca Scazzina Ph.D., University of Parma

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 couscous. 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 compared to a similar durum wheat based product, couscous.

Condition or disease Intervention/treatment Phase
Dietary Modification Other: Short pasta (dry) Other: Long pasta (dry) Other: Couscous Other: Glucose Not Applicable

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 couscous 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Personnel involved in randomization, in the analyses of the samples collected, and who were involved in the data processing were blinded.
Primary Purpose: Basic Science
Official Title: Pasta and Couscous Prepared With Durum Wheat Semolina: Effect on Post-prandial Glucose and Insulin Metabolism
Actual Study Start Date : March 13, 2017
Actual Primary Completion Date : July 13, 2018
Actual Study Completion Date : July 13, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Active Comparator: Couscous (dry)
Cooked couscous (50g available carbohydrate, 70g uncooked) eaten with 500 mL of water
Other: Couscous
50g available carbohydrate portion of couscous (~70g uncooked) will be cooked according to package instructions and served with 500mL water

Experimental: Short pasta (dry)
Cooked penne (50g available carbohydrate, 71g uncooked) eaten with 500 mL of water
Other: Short pasta (dry)
50g available carbohydrate portion of penne (~71g uncooked) will be cooked according to package instructions and served with 500mL water
Other Name: Penne

Experimental: Long pasta (dry)
Cooked spaghetti (50g available carbohydrate, 71g uncooked) eaten with 500 mL of water
Other: Long pasta (dry)
50g available carbohydrate portion of spaghetti (~71g uncooked) will be cooked according to package instructions and served with 500mL water
Other Name: Spaghetti

Active Comparator: Glucose
Glucose monohydrate (55 g) dissolved with 500 mL of water
Other: Glucose
50g available carbohydrate portion of glucose monohydrate (~55g) will be dissolved in 500mL water




Primary Outcome Measures :
  1. incremental area under the curve for blood glucose [ Time Frame: Time Frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes) ]
    postprandial IAUC of blood glucose

  2. incremental area under the curve for plasma insulin [ Time Frame: Time Frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes) ]
    postprandial IAUC for plasma insulin


Secondary Outcome Measures :
  1. post-prandial c-peptide plasma concentration [ Time Frame: Time Frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes) ]
    postprandial IAUC for plasma c-peptide



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098017


Locations
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Italy
Department of Food Science, University of Parma
Parma, Italy, 43125
Sponsors and Collaborators
University of Parma
Investigators
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Principal Investigator: Francesca Scazzina, PhD Department of Food Science, University of Parma
Study Director: Furio Brighenti, PhD Department of Food Science, University of Parma

Publications:
Petitot, M., Abecassis, J. & Micard, V. Structuring of pasta components during processing: impact on starch and protein digestibility and allergenicity. Trends Food Sci Tech. 2009;20,521-532

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Responsible Party: Francesca Scazzina Ph.D., Assistant Professor, University of Parma
ClinicalTrials.gov Identifier: NCT03098017     History of Changes
Other Study ID Numbers: Couscous2
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No