NCT03024983

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

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

September 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

9 months

First QC Date

January 16, 2017

Last Update Submit

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 COMPARATOR

Glucose monohydrate (isoglucidic portion -50 g of available carbohydrates-)

Other: Glucose

Semolina

EXPERIMENTAL

Semolina soup (isoglucidic portion -50 g of available carbohydrates-)

Other: Semolina soup

Bread

EXPERIMENTAL

Bread (isoglucidic portion -50 g of available carbohydrates-)

Other: Bread

Short pasta (fresh)

EXPERIMENTAL

Fresh penne (isoglucidic portion -50 g of available carbohydrates-)

Other: Penne (fresh)

Short pasta (dry)

EXPERIMENTAL

Short pasta (dry) (isoglucidic portion -50 g of available carbohydrates-)

Other: Penne (dry)

Long pasta (dry)

EXPERIMENTAL

Long pasta (dry) (isoglucidic portion -50 g of available carbohydrates-)

Other: Spaghetti (dry)

Interventions

GlucoseOTHER

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

Control

Semolina soup (322 g) eaten with 500 mL of water

Semolina
BreadOTHER

Bread (122 g) eaten with 500 mL of water

Bread

Cooked penne (132 g) eaten with 500 mL of water

Short pasta (fresh)

Cooked penne (142 g) eaten with 500 mL of water

Short pasta (dry)

Cooked spaghetti (142 g) eaten with 500 mL of water

Long pasta (dry)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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.

    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
  • 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
  • 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

MeSH Terms

Interventions

GlucoseBreadDesiccation

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesChemistry Techniques, AnalyticalInvestigative TechniquesChemical Phenomena

Study Officials

  • Francesca Scazzina, Professor

    Department of Food Science, University of Parma

    PRINCIPAL INVESTIGATOR
  • Furio Brighenti, Professor

    Department of Food Science, University of Parma

    STUDY DIRECTOR

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

Locations