A Trial on the GI of Spaghetti Versus Rice as Mixed Meals

NCT03104712 | Completed

• 1 other identifier: Pasta+Sauces
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Pasta and rice are two of the most commonly consumed grains worldwide, where the former has a low GI (e.g. spaghetti) and the latter, usually (as it depends on the type) has a higher GI (e.g. white rice). The most typical ways in which pasta and rice are consumed are with the addition of oil or tomato sauce, and are recommended to be consumed in this way in the Mediterranean diet. The Mediterranean diet has been demonstrated to reduce the risk of cardiovascular disease, improve glycemic control and is encouraged in many clinical guidelines globally for both cardiovascular risk reduction. Some studies have explored the differences in glycemic response of different carbohydrate foods consumed with the addition of fat demonstrating that the glycemic response is indeed reduced.However, the GI may remain of importance even when other means to reduce glycemic response are introduced. The investigators therefore designed a randomized controlled crossover study to explore whether the addition of fat in the form of commonly consumed sauces which are recommended as part of a Mediterranean diet, affects the difference in glycemic response between a commonly consumed low GI and a higher GI carbohydrate food.

Conditions

Dietary Modification

Keywords

glycemic index

Outcome Measures

Primary Outcomes (1)

• Glycemic Index

  postprandial response for glucose (IAUC); Comparisons will be made between the spaghetti and rice IAUCs in each of the 3 contexts (alone, with tomato sauce, with pesto)

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

Secondary Outcomes (3)

• Postprandial Insulin

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

• Postprandial C-peptide

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

• Peak Glucose

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

Other Outcomes (3)

• Satiety using a 100cm visual analog scale

  2 hours

• Palatability using a 100cm visual analog scale

  12 minutes

• Gastrointestinal Symptoms using a questionnaire

  2 hours

Study Arms (9)

Glucose #1

OTHER

50 grams of available carbohydrate from glucose monohydrate will be dissolved in 250mL water and consumed as a test meal

Other: Glucose #1

Spaghetti

ACTIVE COMPARATOR

50 grams of available carbohydrate from spaghetti will be cooked according to package instructions and consumed as a test meal

Other: Spaghetti

Rice

ACTIVE COMPARATOR

50 grams of available carbohydrate from white rice will be cooked according to package instructions and consumed as a test meal

Other: Rice

Spaghetti + tomato sauce

ACTIVE COMPARATOR

50 grams of available carbohydrate from spaghetti plus tomato sauce (1:1 ratio) will be cooked according to package instructions and consumed as a test meal

Other: Spaghetti + Tomato Sauce

Rice + tomato sauce

ACTIVE COMPARATOR

50 grams of available carbohydrate from white rice plus tomato sauce (1:1 ratio) will be cooked according to package instructions and consumed as a test meal

Other: Rice + Tomato Sauce

Spaghetti + Pesto

ACTIVE COMPARATOR

50 grams of available carbohydrate from spaghetti plus pesto sauce (1:0.5 ratio) will be cooked according to package instructions and consumed as a test meal

Other: Spaghetti + Pesto

Rice + Pesto

ACTIVE COMPARATOR

50 grams of available carbohydrate from white rice plus pesto sauce (1:0.5 ratio) will be cooked according to package instructions and consumed as a test meal

Other: Rice + Pesto

Glucose #2

OTHER

50 grams of available carbohydrate from glucose monohydrate will be dissolved in 250mL water and consumed as a test meal

Other: Glucose #2

Glucose #3

OTHER

50 grams of available carbohydrate from glucose monohydrate will be dissolved in 250mL water and consumed as a test meal

Other: Glucose #3

Interventions

Glucose #1 OTHER

50g available carbohydrate

Also known as: Glucose Monohydrate

Glucose #1

Glucose #2 OTHER

50g available carbohydrate

Also known as: Glucose Monohydrate

Glucose #2

Glucose #3 OTHER

50g available carbohydrate

Also known as: Glucose Monohydrate

Glucose #3

Spaghetti OTHER

50g available carbohydrate

Spaghetti

Rice OTHER

50g available carbohydrate

Also known as: white rice

Rice

Spaghetti + Tomato Sauce OTHER

50g available carbohydrate

Spaghetti + tomato sauce

Rice + Tomato Sauce OTHER

50g available carbohydrate

Also known as: white rice + tomato sauce

Rice + tomato sauce

Spaghetti + Pesto OTHER

50g available carbohydrate

Spaghetti + Pesto

Rice + Pesto OTHER

50g available carbohydrate

Also known as: white rice + pesto

Rice + Pesto

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• generally healthy

You may not qualify if:

• BMI≥30kg/m2
• have any health conditions (including anemia and metabolic conditions such as hypertension, dyslipidemia, impaired glucose intolerance or diabetes)
• have celiac disease
• perform intense physical activity (LAF ≥2.10 - LARN 2014)
• currently taking any prescription medication for chronic diseases (including psychiatric)
• dietary supplements affecting the metabolism
• Women who are pregnant or breastfeeding

Sponsors & Collaborators

• University of Parma: lead

Study Sites (1)

Department of Food and Drug, University of Parma

Parma, 43125, Italy

Location

Related Publications (17)

• Ajala O, English P, Pinkney J. Systematic review and meta-analysis of different dietary approaches to the management of type 2 diabetes. Am J Clin Nutr. 2013 Mar;97(3):505-16. doi: 10.3945/ajcn.112.042457. Epub 2013 Jan 30.

  PMID: 23364002 BACKGROUND

• Barclay AW, Petocz P, McMillan-Price J, Flood VM, Prvan T, Mitchell P, Brand-Miller JC. Glycemic index, glycemic load, and chronic disease risk--a meta-analysis of observational studies. Am J Clin Nutr. 2008 Mar;87(3):627-37. doi: 10.1093/ajcn/87.3.627.

  PMID: 18326601 BACKGROUND

• Mirrahimi A, de Souza RJ, Chiavaroli L, Sievenpiper JL, Beyene J, Hanley AJ, Augustin LS, Kendall CW, Jenkins DJ. Associations of glycemic index and load with coronary heart disease events: a systematic review and meta-analysis of prospective cohorts. J Am Heart Assoc. 2012 Oct;1(5):e000752. doi: 10.1161/JAHA.112.000752. Epub 2012 Oct 25.

  PMID: 23316283 BACKGROUND

• Moghaddam E, Vogt JA, Wolever TM. The effects of fat and protein on glycemic responses in nondiabetic humans vary with waist circumference, fasting plasma insulin, and dietary fiber intake. J Nutr. 2006 Oct;136(10):2506-11. doi: 10.1093/jn/136.10.2506.

  PMID: 16988118 BACKGROUND

• Thomas D, Elliott EJ. Low glycaemic index, or low glycaemic load, diets for diabetes mellitus. Cochrane Database Syst Rev. 2009 Jan 21;2009(1):CD006296. doi: 10.1002/14651858.CD006296.pub2.

  PMID: 19160276 BACKGROUND

• Pironi L, Stanghellini V, Miglioli M, Corinaldesi R, De Giorgio R, Ruggeri E, Tosetti C, Poggioli G, Morselli Labate AM, Monetti N, et al. Fat-induced ileal brake in humans: a dose-dependent phenomenon correlated to the plasma levels of peptide YY. Gastroenterology. 1993 Sep;105(3):733-9. doi: 10.1016/0016-5085(93)90890-o.

  PMID: 8359644 BACKGROUND

• Moran TH, Kinzig KP. Gastrointestinal satiety signals II. Cholecystokinin. Am J Physiol Gastrointest Liver Physiol. 2004 Feb;286(2):G183-8. doi: 10.1152/ajpgi.00434.2003.

  PMID: 14715515 BACKGROUND

• Horowitz M, Edelbroek MA, Wishart JM, Straathof JW. Relationship between oral glucose tolerance and gastric emptying in normal healthy subjects. Diabetologia. 1993 Sep;36(9):857-62. doi: 10.1007/BF00400362.

  PMID: 8405758 BACKGROUND

• Rayner CK, Samsom M, Jones KL, Horowitz M. Relationships of upper gastrointestinal motor and sensory function with glycemic control. Diabetes Care. 2001 Feb;24(2):371-81. doi: 10.2337/diacare.24.2.371.

  PMID: 11213895 BACKGROUND

• Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Munoz MA, Sorli JV, Martinez JA, Martinez-Gonzalez MA; PREDIMED Study Investigators. Primary prevention of cardiovascular disease with a Mediterranean diet. N Engl J Med. 2013 Apr 4;368(14):1279-90. doi: 10.1056/NEJMoa1200303. Epub 2013 Feb 25.

  PMID: 23432189 BACKGROUND

• Esposito K, Maiorino MI, Bellastella G, Chiodini P, Panagiotakos D, Giugliano D. A journey into a Mediterranean diet and type 2 diabetes: a systematic review with meta-analyses. BMJ Open. 2015 Aug 10;5(8):e008222. doi: 10.1136/bmjopen-2015-008222.

  PMID: 26260349 BACKGROUND

• Anderson TJ, Gregoire J, Pearson GJ, Barry AR, Couture P, Dawes M, Francis GA, Genest J Jr, Grover S, Gupta M, Hegele RA, Lau DC, Leiter LA, Lonn E, Mancini GB, McPherson R, Ngui D, Poirier P, Sievenpiper JL, Stone JA, Thanassoulis G, Ward R. 2016 Canadian Cardiovascular Society Guidelines for the Management of Dyslipidemia for the Prevention of Cardiovascular Disease in the Adult. Can J Cardiol. 2016 Nov;32(11):1263-1282. doi: 10.1016/j.cjca.2016.07.510. Epub 2016 Jul 25.

  PMID: 27712954 BACKGROUND

• Canadian Diabetes Association Clinical Practice Guidelines Expert Committee; Dworatzek PD, Arcudi K, Gougeon R, Husein N, Sievenpiper JL, Williams SL. Nutrition therapy. Can J Diabetes. 2013 Apr;37 Suppl 1:S45-55. doi: 10.1016/j.jcjd.2013.01.019. Epub 2013 Mar 26. No abstract available.

  PMID: 24070963 BACKGROUND

• Evert AB, Boucher JL, Cypress M, Dunbar SA, Franz MJ, Mayer-Davis EJ, Neumiller JJ, Nwankwo R, Verdi CL, Urbanski P, Yancy WS Jr; American Diabetes Association. Nutrition therapy recommendations for the management of adults with diabetes. Diabetes Care. 2013 Nov;36(11):3821-42. doi: 10.2337/dc13-2042. Epub 2013 Oct 9.

  PMID: 24107659 BACKGROUND

• American Diabetes Association. (4) Foundations of care: education, nutrition, physical activity, smoking cessation, psychosocial care, and immunization. Diabetes Care. 2015 Jan;38 Suppl:S20-30. doi: 10.2337/dc15-S007. No abstract available.

  PMID: 25537702 BACKGROUND

• Vinoy S, Lesdéma A, Cesbron-Lavau G, Goux A, and Meynier A. Chapter 13 Creating Food Products with a Lower Glycemic Index. The Glycemic Index: Applications in Practice. Taylor & Francis Group, 6000 Broken Sound Parkway NW, Suite 300, Boca Raton, FL 33487-2742 CRC Press. Pages 285-318.

  BACKGROUND

• Chiavaroli L, Di Pede G, Dall'Asta M, Cossu M, Francinelli V, Goldoni M, Scazzina F, Brighenti F. The importance of glycemic index on post-prandial glycaemia in the context of mixed meals: A randomized controlled trial on pasta and rice. Nutr Metab Cardiovasc Dis. 2021 Feb 8;31(2):615-625. doi: 10.1016/j.numecd.2020.09.025. Epub 2020 Sep 28.

  PMID: 33229200 DERIVED

MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Francesca Scazzina, PhD

  Department of Food and Drug, University of Parma

  PRINCIPAL INVESTIGATOR

• Furio Brighenti, PhD

  Department of Food and Drug, University of Parma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be unaware of the intervention associated with the samples being analyzed.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 7, 2017
• Study Start: April 27, 2017
• Primary Completion: March 12, 2018
• Study Completion: April 30, 2018
• Last Updated: May 3, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)