Pasta and Other Durum Wheat-based Products: Effects on Post-prandial Glucose Metabolism
1 other identifier
interventional
18
1 country
1
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 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 16, 2017
CompletedFirst Posted
Study publicly available on registry
January 19, 2017
CompletedJanuary 19, 2017
January 1, 2017
9 months
January 16, 2017
January 18, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
incremental area under the curve for plasma glucose
2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
Secondary Outcomes (5)
post-prandial insulin plasma concentration
2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
post-prandial c-peptide plasma concentration
2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
post-prandial GLP-1 plasma concentration
2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
post-prandial GIP plasma concentration
2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
post-prandial glucagon plasma concentration
2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
Study Arms (6)
Control
ACTIVE COMPARATORGlucose monohydrate (isoglucidic portion -50 g of available carbohydrates-)
Semolina
EXPERIMENTALSemolina soup (isoglucidic portion -50 g of available carbohydrates-)
Bread
EXPERIMENTALBread (isoglucidic portion -50 g of available carbohydrates-)
Short pasta (fresh)
EXPERIMENTALFresh penne (isoglucidic portion -50 g of available carbohydrates-)
Short pasta (dry)
EXPERIMENTALShort pasta (dry) (isoglucidic portion -50 g of available carbohydrates-)
Long pasta (dry)
EXPERIMENTALLong pasta (dry) (isoglucidic portion -50 g of available carbohydrates-)
Interventions
Eligibility Criteria
You may qualify if:
- healthy male and female (age ≥ 18 years)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Food Science, University of Parma
Parma, Parma, 43125, Italy
Related Publications (16)
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.
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PMID: 3276722BACKGROUNDDong 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.
PMID: 22017823BACKGROUNDGannon 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.
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PMID: 3383733BACKGROUNDJenkins 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.
PMID: 6259925BACKGROUNDLivesey 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.
PMID: 23364021BACKGROUNDLudwig 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.
PMID: 11988062BACKGROUNDMa 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.
PMID: 22727193BACKGROUNDOnitilo 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.
PMID: 23962874BACKGROUNDOstlund 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.
PMID: 2403660BACKGROUNDPetitot, 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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PMID: 23786819BACKGROUNDSieri 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.
PMID: 20386010BACKGROUNDWeyer 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.
PMID: 11344187BACKGROUNDWolever 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.
PMID: 3743316BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francesca Scazzina, Professor
Department of Food Science, University of Parma
- STUDY DIRECTOR
Furio Brighenti, Professor
Department of Food Science, University of Parma
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 16, 2017
First Posted
January 19, 2017
Study Start
September 1, 2015
Primary Completion
June 1, 2016
Study Completion
July 1, 2016
Last Updated
January 19, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share