- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03104686
Pasta and Bread Prepared With Durum Wheat Semolina: Effect on Post-prandial Glucose and Insulin Metabolism
September 10, 2018 updated by: Francesca Scazzina Ph.D., University of Parma
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Parma, Italy, 43125
- Department of Food Science, University of Parma
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Glucose
Glucose monohydrate (55 g) dissolved with 500 mL of water
|
50g available carbohydrate of glucose monohydrate
|
Active Comparator: Bread
Bread (50g available carbohydrate, 109 g) eaten with 500 mL of water
|
50g available carbohydrate of bread
|
Experimental: Short pasta (dry)
Cooked penne (142 g; 71 g uncooked) eaten with 500 mL of water
|
50g available carbohydrate of penne pasta
Other Names:
|
Experimental: Long pasta (dry)
Cooked spaghetti (142 g; 71 g uncooked) eaten with 500 mL of water
|
50g available carbohydrate of spaghetti pasta
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
|
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)
|
2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Weyer C, Funahashi T, Tanaka S, Hotta K, Matsuzawa Y, Pratley RE, Tataranni PA. Hypoadiponectinemia in obesity and type 2 diabetes: close association with insulin resistance and hyperinsulinemia. J Clin Endocrinol Metab. 2001 May;86(5):1930-5. doi: 10.1210/jcem.86.5.7463.
- Jenkins DJ, Wolever TM, Taylor RH, Barker H, Fielden H, Baldwin JM, Bowling AC, Newman HC, Jenkins AL, Goff DV. Glycemic index of foods: a physiological basis for carbohydrate exchange. Am J Clin Nutr. 1981 Mar;34(3):362-6. doi: 10.1093/ajcn/34.3.362.
- Blaak EE, Antoine JM, Benton D, Bjorck I, Bozzetto L, Brouns F, Diamant M, Dye L, Hulshof T, Holst JJ, Lamport DJ, Laville M, Lawton CL, Meheust A, Nilson A, Normand S, Rivellese AA, Theis S, Torekov SS, Vinoy S. Impact of postprandial glycaemia on health and prevention of disease. Obes Rev. 2012 Oct;13(10):923-84. doi: 10.1111/j.1467-789X.2012.01011.x. Epub 2012 Jul 11.
- Collier GR, Greenberg GR, Wolever TM, Jenkins DJ. The acute effect of fat on insulin secretion. J Clin Endocrinol Metab. 1988 Feb;66(2):323-6. doi: 10.1210/jcem-66-2-323.
- Dong JY, Zhang L, Zhang YH, Qin LQ. Dietary glycaemic index and glycaemic load in relation to the risk of type 2 diabetes: a meta-analysis of prospective cohort studies. Br J Nutr. 2011 Dec;106(11):1649-54. doi: 10.1017/S000711451100540X. Epub 2011 Sep 29.
- Gannon MC, Nuttall FQ, Neil BJ, Westphal SA. The insulin and glucose responses to meals of glucose plus various proteins in type II diabetic subjects. Metabolism. 1988 Nov;37(11):1081-8. doi: 10.1016/0026-0495(88)90072-8.
- Jenkins DJ, Wolever TM, Jenkins AL. Starchy foods and glycemic index. Diabetes Care. 1988 Feb;11(2):149-59. doi: 10.2337/diacare.11.2.149.
- Livesey G, Taylor R, Livesey H, Liu S. Is there a dose-response relation of dietary glycemic load to risk of type 2 diabetes? Meta-analysis of prospective cohort studies. Am J Clin Nutr. 2013 Mar;97(3):584-96. doi: 10.3945/ajcn.112.041467. Epub 2013 Jan 30.
- Ludwig DS. The glycemic index: physiological mechanisms relating to obesity, diabetes, and cardiovascular disease. JAMA. 2002 May 8;287(18):2414-23. doi: 10.1001/jama.287.18.2414.
- Ma XY, Liu JP, Song ZY. Glycemic load, glycemic index and risk of cardiovascular diseases: meta-analyses of prospective studies. Atherosclerosis. 2012 Aug;223(2):491-6. doi: 10.1016/j.atherosclerosis.2012.05.028. Epub 2012 Jun 6.
- Onitilo AA, Stankowski RV, Berg RL, Engel JM, Glurich I, Williams GM, Doi SA. Type 2 diabetes mellitus, glycemic control, and cancer risk. Eur J Cancer Prev. 2014 Mar;23(2):134-40. doi: 10.1097/CEJ.0b013e3283656394.
- Ostlund RE Jr, Staten M, Kohrt WM, Schultz J, Malley M. The ratio of waist-to-hip circumference, plasma insulin level, and glucose intolerance as independent predictors of the HDL2 cholesterol level in older adults. N Engl J Med. 1990 Jan 25;322(4):229-34. doi: 10.1056/NEJM199001253220404.
- Schwingshackl L, Hoffmann G. Long-term effects of low glycemic index/load vs. high glycemic index/load diets on parameters of obesity and obesity-associated risks: a systematic review and meta-analysis. Nutr Metab Cardiovasc Dis. 2013 Aug;23(8):699-706. doi: 10.1016/j.numecd.2013.04.008. Epub 2013 Jun 17.
- Sieri S, Krogh V, Berrino F, Evangelista A, Agnoli C, Brighenti F, Pellegrini N, Palli D, Masala G, Sacerdote C, Veglia F, Tumino R, Frasca G, Grioni S, Pala V, Mattiello A, Chiodini P, Panico S. Dietary glycemic load and index and risk of coronary heart disease in a large italian cohort: the EPICOR study. Arch Intern Med. 2010 Apr 12;170(7):640-7. doi: 10.1001/archinternmed.2010.15.
- Wolever TM, Jenkins DJ, Kalmusky J, Giordano C, Giudici S, Jenkins AL, Thompson LU, Wong GS, Josse RG. Glycemic response to pasta: effect of surface area, degree of cooking, and protein enrichment. Diabetes Care. 1986 Jul-Aug;9(4):401-4. doi: 10.2337/diacare.9.4.401.
- 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
- Vanhatalo S, Dall'Asta M, Cossu M, Chiavaroli L, Francinelli V, Pede GD, Dodi R, Narvainen J, Antonini M, Goldoni M, Holopainen-Mantila U, Cas AD, Bonadonna R, Brighenti F, Poutanen K, Scazzina F. Pasta Structure Affects Mastication, Bolus Properties, and Postprandial Glucose and Insulin Metabolism in Healthy Adults. J Nutr. 2022 Apr 1;152(4):994-1005. doi: 10.1093/jn/nxab361.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 10, 2017
Primary Completion (Actual)
June 15, 2018
Study Completion (Actual)
June 15, 2018
Study Registration Dates
First Submitted
February 28, 2017
First Submitted That Met QC Criteria
April 3, 2017
First Posted (Actual)
April 7, 2017
Study Record Updates
Last Update Posted (Actual)
September 12, 2018
Last Update Submitted That Met QC Criteria
September 10, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- Pane2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dietary Modification
-
University of ReadingUnknownDietary Habits | Dietary ModificationUnited Kingdom
-
University of ReadingCompletedDietary Habits | Dietary ModificationUnited Kingdom
-
Brown UniversityNational Cancer Institute (NCI); University of ConnecticutCompletedDietary Habits | Dietary Modification
-
Akron Children's HospitalCompletedDietary ModificationUnited States
-
The Second Affiliated Hospital of Chongqing Medical...Baxter Healthcare CorporationCompletedDietary Modification
-
University of GeorgiaCompleted
-
University of ParmaCompleted
-
ClasadoCompletedDietary Modification
-
University of BirminghamGlaxoSmithKlineUnknownDietary ModificationUnited Kingdom
Clinical Trials on Bread
-
Glycemic Index Laboratories, IncUniversity of Guelph; Guelph Research and Development Centre, Agriculture and...Completed
-
Paulic Meunerie SAInstitut Polytechnique UniLaSalleCompleted
-
KU LeuvenRecruitingAppetite Regulation | Energy IntakeBelgium
-
Newcastle-upon-Tyne Hospitals NHS TrustBiotechnology and Biological Sciences Research CouncilCompleted
-
University of Eastern FinlandVTT Technical Research Centre of FinlandCompletedGlucose Metabolism Disorders | Inflammation | Intestinal Disorder
-
Organización Interprofesional Agroalimentaria de...Universidad de GranadaCompleted
-
West German Center of Diabetes and HealthBakery HinkelCompleted
-
Örebro University, SwedenCompleted
-
University of AberdeenCompletedHealthy | OverweightUnited Kingdom
-
University of AberdeenUnknownNon Coeliac Gluten SensitivityUnited Kingdom