- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03024983
Pasta and Other Durum Wheat-based Products: Effects on Post-prandial Glucose Metabolism
January 18, 2017 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 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 response (post-prandial glucose, insulin, GLP-1, GIP plasma concentrations).
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 (Livesey et al, 2013; Dong et al, 2011) and cardiovascular disease (Ludwig, 2002; Blaak et al, 2012)), to control inflammatory status (Ma et al, 2012; Sieri et al, 2010), which is the trigger of several pathologies, and to reduce fasting insulin (Schwingshackl & Hoffmann, 2013).
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 (Gannon et al, 1988; Gannon et al, 1993; Collier et al. 1988).
Avoiding a high insulin post-prandial response after consumption of foods represents a preventive factor against the risk of overweight and hyperlipidemia (Ostlund et al, 1990), type 2 diabetes (Weyer et al, 2001), and cancer (Onitilo et al, 2014).
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 (Jenkins et al, 1988; Jenkins et al, 1981; Wolever et al, 1986), and this is due to the technological structures characterizing the two matrices (Petitot et al, 2009).
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 other durum wheat based products on the plasma response of glucose, insulin, and other hormones related to the glucose metabolism (c-peptide, GLP-1 and GIP) 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)
18
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
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion criteria:
- healthy male and female (age ≥ 18 years)
Exclusion Criteria:
- 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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Control
Glucose monohydrate (isoglucidic portion -50 g of available carbohydrates-)
|
Glucose monohydrate (55 g) dissolved with 500 mL of water
|
|
EXPERIMENTAL: Semolina
Semolina soup (isoglucidic portion -50 g of available carbohydrates-)
|
Semolina soup (322 g) eaten with 500 mL of water
|
|
EXPERIMENTAL: Bread
Bread (isoglucidic portion -50 g of available carbohydrates-)
|
Bread (122 g) eaten with 500 mL of water
|
|
EXPERIMENTAL: Short pasta (fresh)
Fresh penne (isoglucidic portion -50 g of available carbohydrates-)
|
Cooked penne (132 g) eaten with 500 mL of water
|
|
EXPERIMENTAL: Short pasta (dry)
Short pasta (dry) (isoglucidic portion -50 g of available carbohydrates-)
|
Cooked penne (142 g) eaten with 500 mL of water
|
|
EXPERIMENTAL: Long pasta (dry)
Long pasta (dry) (isoglucidic portion -50 g of available carbohydrates-)
|
Cooked spaghetti (142 g) eaten with 500 mL of water
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
incremental area under the curve for plasma glucose
Time Frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
|
2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
post-prandial insulin plasma concentration
Time Frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
|
2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
|
|
post-prandial c-peptide plasma concentration
Time Frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
|
2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
|
|
post-prandial GLP-1 plasma concentration
Time Frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
|
2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
|
|
post-prandial GIP plasma concentration
Time Frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
|
2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
|
|
post-prandial glucagon plasma concentration
Time Frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
|
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, Professor, Department of Food Science, University of Parma
- Study Director: Furio Brighenti, Professor, 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
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
September 1, 2015
Primary Completion (ACTUAL)
June 1, 2016
Study Completion (ACTUAL)
July 1, 2016
Study Registration Dates
First Submitted
January 16, 2017
First Submitted That Met QC Criteria
January 18, 2017
First Posted (ESTIMATE)
January 19, 2017
Study Record Updates
Last Update Posted (ESTIMATE)
January 19, 2017
Last Update Submitted That Met QC Criteria
January 18, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- DWP1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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