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

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ClinicalTrials.gov Identifier: NCT03104686
Recruitment Status : Completed
First Posted : April 7, 2017
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Francesca Scazzina Ph.D., University of Parma

Tracking Information
First Submitted Date  ICMJE February 28, 2017
First Posted Date  ICMJE April 7, 2017
Last Update Posted Date September 12, 2018
Actual Study Start Date  ICMJE April 10, 2017
Actual Primary Completion Date June 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2017)
  • 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)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03104686 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2017)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pasta and Bread Prepared With Durum Wheat Semolina: Effect on Post-prandial Glucose and Insulin Metabolism
Official Title  ICMJE Pasta and Bread Prepared With Durum Wheat Semolina: Effect on Post-prandial Glucose and Insulin Metabolism
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Dietary Modification
Intervention  ICMJE
  • Other: Short pasta (dry)
    50g available carbohydrate of penne pasta
    Other Name: Penne
  • Other: Long pasta (dry)
    50g available carbohydrate of spaghetti pasta
    Other Name: Spaghetti
  • Other: Bread
    50g available carbohydrate of bread
  • Other: Glucose
    50g available carbohydrate of glucose monohydrate
Study Arms  ICMJE
  • Active Comparator: Bread
    Bread (50g available carbohydrate, 109 g) eaten with 500 mL of water
    Intervention: Other: Bread
  • Experimental: Short pasta (dry)
    Cooked penne (142 g; 71 g uncooked) eaten with 500 mL of water
    Intervention: Other: Short pasta (dry)
  • Experimental: Long pasta (dry)
    Cooked spaghetti (142 g; 71 g uncooked) eaten with 500 mL of water
    Intervention: Other: Long pasta (dry)
  • Active Comparator: Glucose
    Glucose monohydrate (55 g) dissolved with 500 mL of water
    Intervention: Other: Glucose
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 15, 2018
Actual Primary Completion Date June 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03104686
Other Study ID Numbers  ICMJE Pane2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Francesca Scazzina Ph.D., University of Parma
Study Sponsor  ICMJE University of Parma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francesca Scazzina, PhD Department of Food Science, University of Parma
Study Director: Furio Brighenti, PhD Department of Food Science, University of Parma
PRS Account University of Parma
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP