NCT03098017

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 28, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

March 13, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2018

Completed
Last Updated

September 12, 2018

Status Verified

September 1, 2018

Enrollment Period

1.3 years

First QC Date

February 28, 2017

Last Update Submit

September 10, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • incremental area under the curve for blood glucose

    postprandial IAUC of blood glucose

    Time Frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)

  • incremental area under the curve for plasma insulin

    postprandial IAUC for plasma insulin

    Time Frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)

Secondary Outcomes (1)

  • post-prandial c-peptide plasma concentration

    Time Frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)

Study Arms (4)

Couscous (dry)

ACTIVE COMPARATOR

Cooked couscous (50g available carbohydrate, 70g uncooked) eaten with 500 mL of water

Other: Couscous

Short pasta (dry)

EXPERIMENTAL

Cooked penne (50g available carbohydrate, 71g uncooked) eaten with 500 mL of water

Other: Short pasta (dry)

Long pasta (dry)

EXPERIMENTAL

Cooked spaghetti (50g available carbohydrate, 71g uncooked) eaten with 500 mL of water

Other: Long pasta (dry)

Glucose

ACTIVE COMPARATOR

Glucose monohydrate (55 g) dissolved with 500 mL of water

Other: Glucose

Interventions

50g available carbohydrate portion of penne (\~71g uncooked) will be cooked according to package instructions and served with 500mL water

Also known as: Penne
Short pasta (dry)

50g available carbohydrate portion of spaghetti (\~71g uncooked) will be cooked according to package instructions and served with 500mL water

Also known as: Spaghetti
Long pasta (dry)

50g available carbohydrate portion of couscous (\~70g uncooked) will be cooked according to package instructions and served with 500mL water

Couscous (dry)
GlucoseOTHER

50g available carbohydrate portion of glucose monohydrate (\~55g) will be dissolved in 500mL water

Glucose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy male and female

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Food Science, University of Parma

Parma, 43125, Italy

Location

Related Publications (17)

  • 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.

    PMID: 22780564BACKGROUND
  • 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.

    PMID: 3276722BACKGROUND
  • 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.

    PMID: 22017823BACKGROUND
  • 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.

    PMID: 3054432BACKGROUND
  • 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.

    PMID: 3383733BACKGROUND
  • 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.

    PMID: 6259925BACKGROUND
  • 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.

    PMID: 23364021BACKGROUND
  • 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.

    PMID: 11988062BACKGROUND
  • 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.

    PMID: 22727193BACKGROUND
  • 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.

    PMID: 23962874BACKGROUND
  • 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.

    PMID: 2403660BACKGROUND
  • 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.

    PMID: 23786819BACKGROUND
  • 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.

    PMID: 20386010BACKGROUND
  • 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.

    PMID: 11344187BACKGROUND
  • 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.

    PMID: 3743316BACKGROUND
  • 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

    BACKGROUND
  • 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.

MeSH Terms

Interventions

DesiccationGlucose

Intervention Hierarchy (Ancestors)

Chemistry Techniques, AnalyticalInvestigative TechniquesChemical PhenomenaHexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Francesca Scazzina, PhD

    Department of Food Science, University of Parma

    PRINCIPAL INVESTIGATOR
  • Furio Brighenti, PhD

    Department of Food Science, University of Parma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Personnel involved in randomization, in the analyses of the samples collected, and who were involved in the data processing were blinded.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 28, 2017

First Posted

March 31, 2017

Study Start

March 13, 2017

Primary Completion

July 13, 2018

Study Completion

July 13, 2018

Last Updated

September 12, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations