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

Dietary Modification Clinical Trial

Official title:

The Importance of Glycemic Index on Postprandial Glycemia and Insulinemia in the Context of the Addition of Fat to Carbohydrate Foods: A Randomized Controlled Trial on Spaghetti Versus Rice as Mixed Meals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03104712
• Other study ID #: Pasta+Sauces
• Status: Completed
• Phase: N/A
• Start date: April 27, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: May 2018
• Source: University of Parma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Background:

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). Low GI foods have been demonstrated to improve glycemic control, insulin sensitivity and diabetes management, and have been associated with reduced risk of chronic disease, including coronary heart disease. Therefore, GI is of importance as a potential dietary strategy to reduce postprandial glycemia and improve glycemic control, particularly with the increasing rates of diabetes.

Several studies have demonstrated how the addition of fat to a meal can reduce the glycemic response, some of which have suggested in a dose response manner. The mechanism by which increasing fat reduces the glycemic response may be through the effects on gastric emptying. Fat may modulate the gut hormones cholecystokinin (CCK) and peptide YY, which delay gastric emptying, which is known to be a major determinant of postprandial glycemia where small changes can have a substantial effect. Low GI foods result in lower glycemic excursions compared to higher GI foods, which, in addition to gastric emptying, may exert this effect through various pathways. Thus, there is importance of exploring the potential additional benefit beyond reducing the glycemic response with the addition of fat.

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. Among many benefits, the Mediterranean diet has been demonstrated to reduce the risk of cardiovascular disease, improved glycemic control and is encouraged in many clinical guidelines globally for both cardiovascular risk reduction and for diabetes. 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.

Objective:

To assess whether the addition of fat to a low GI and higher GI carbohydrate food lowers the glycemic response equivalently, thus whether the difference between the low and higher GI food is preserved.

Scope:

The principal scope of the study is to evaluate the impact of two carbohydrate-containing foods varying in glycemic index, spaghetti and rice, on postprandial glucose.

To confirm that the two foods vary in GI, the GI of the rice will first be tested in Part A, since the GI of spaghetti has already been determined in the investigator's lab.

In Part B of the study, following the consumption of the test foods by healthy volunteers (see Study Design), the investigators will evaluate the differences in postprandial glucose, as well as insulin and c-peptide.

Implications:

These results will determine whether there is an independent effect of the GI of a carbohydrate containing food when fat is added to a meal in the context of how is it commonly and recommended to be consumed. These results may be useful to encourage the use of low GI foods for greater improvements in glycemic and insulinemic control, which is an important public health concern in today's global society.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 30, 2018
• Est. primary completion date: March 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• generally healthy

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Dietary Modification

Intervention

Other:
• Glucose #1
50g available carbohydrate
• Glucose #2
50g available carbohydrate
• Glucose #3
50g available carbohydrate
• Spaghetti
50g available carbohydrate
• Rice
50g available carbohydrate
• Spaghetti + Tomato Sauce
50g available carbohydrate
• Rice + Tomato Sauce
50g available carbohydrate
• Spaghetti + Pesto
50g available carbohydrate
• Rice + Pesto
50g available carbohydrate

Locations

Country	Name	City	State
Italy	Department of Food and Drug, University of Parma	Parma

Sponsors (1)

Lead Sponsor	Collaborator
University of Parma

Country where clinical trial is conducted

Italy, 

References & Publications (16)

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Anderson TJ, Grégoire 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. Review. — View Citation

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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. — View Citation

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. Review. — View Citation

Estruch R, Ros E, Salas-Salvadó J, Covas MI, Corella D, Arós F, Gómez-Gracia E, Ruiz-Gutiérrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pintó X, Basora J, Muñoz MA, Sorlí JV, Martínez JA, Martínez-González 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. Erratum in: N Engl J Med. 2014 Feb 27;370(9):886. — View Citation

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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. — View Citation

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. Review. — View Citation

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Moran TH, Kinzig KP. Gastrointestinal satiety signals II. Cholecystokinin. Am J Physiol Gastrointest Liver Physiol. 2004 Feb;286(2):G183-8. Review. — View Citation

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. — View Citation

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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.

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satiety using a 100cm visual analog scale	differences in subject-rated satiety using a 100cm visual analog scale	2 hours
Other	Palatability using a 100cm visual analog scale	differences in subject-rated palatability using a 100cm visual analog scale	12 minutes
Other	Gastrointestinal Symptoms using a questionnaire	differences in subject-rated gastrointestinal symptom questionnaire	2 hours
Primary	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	Postprandial Insulin	postprandial response for plasma insulin (IAUC)	2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
Secondary	Postprandial C-peptide	postprandial response for plasma c-peptide (IAUC)	2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
Secondary	Peak Glucose	maximum value of postprandial glucose response	2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)