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

Sponsor
University of Parma (Other)
Overall Status
Completed
CT.gov ID
NCT03098017
Collaborator
(none)
30
Enrollment
1
Location
4
Arms
16
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Short pasta (dry)
  • Other: Long pasta (dry)
  • Other: Couscous
  • Other: Glucose
 N/A

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.

Study Design

Study Type:
Interventional
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 :
Mar 13, 2017
Actual Primary Completion Date :
Jul 13, 2018
Actual Study Completion Date :
Jul 13, 2018

Arms and Interventions

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 Names:
  • 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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    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 IAUC of blood glucose

    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 IAUC for plasma insulin

    Secondary Outcome Measures

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

      postprandial IAUC for plasma c-peptide

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Food Science, University of Parma Parma Italy 43125

    Sponsors and Collaborators

    • University of Parma

    Investigators

    • Principal Investigator: Francesca Scazzina, PhD, Department of Food Science, University of Parma
    • Study Director: Furio Brighenti, PhD, Department of Food Science, University of Parma

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Francesca Scazzina Ph.D., Assistant Professor, University of Parma
    ClinicalTrials.gov Identifier:
    NCT03098017
    Other Study ID Numbers:
    • Couscous2
    First Posted:
    Mar 31, 2017
    Last Update Posted:
    Sep 12, 2018
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Sep 12, 2018