A Trial on the GI of Spaghetti Versus Rice as Mixed Meals
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
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.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed 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.
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Parma, Italy, 43125
- Department of Food and Drug, University of Parma
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
OTHER: Glucose #1
50 grams of available carbohydrate from glucose monohydrate will be dissolved in 250mL water and consumed as a test meal
|
50g available carbohydrate
Other Names:
|
|
ACTIVE_COMPARATOR: Spaghetti
50 grams of available carbohydrate from spaghetti will be cooked according to package instructions and consumed as a test meal
|
50g available carbohydrate
|
|
ACTIVE_COMPARATOR: Rice
50 grams of available carbohydrate from white rice will be cooked according to package instructions and consumed as a test meal
|
50g available carbohydrate
Other Names:
|
|
ACTIVE_COMPARATOR: Spaghetti + tomato sauce
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
|
50g available carbohydrate
|
|
ACTIVE_COMPARATOR: Rice + tomato sauce
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
|
50g available carbohydrate
Other Names:
|
|
ACTIVE_COMPARATOR: Spaghetti + Pesto
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
|
50g available carbohydrate
|
|
ACTIVE_COMPARATOR: Rice + Pesto
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
|
50g available carbohydrate
Other Names:
|
|
OTHER: Glucose #2
50 grams of available carbohydrate from glucose monohydrate will be dissolved in 250mL water and consumed as a test meal
|
50g available carbohydrate
Other Names:
|
|
OTHER: Glucose #3
50 grams of available carbohydrate from glucose monohydrate will be dissolved in 250mL water and consumed as a test meal
|
50g available carbohydrate
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glycemic Index
Time Frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
|
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 Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postprandial Insulin
Time Frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
|
postprandial response for plasma insulin (IAUC)
|
2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
|
|
Postprandial C-peptide
Time Frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
|
postprandial response for plasma c-peptide (IAUC)
|
2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
|
|
Peak Glucose
Time Frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
|
maximum value of postprandial glucose response
|
2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satiety using a 100cm visual analog scale
Time Frame: 2 hours
|
differences in subject-rated satiety using a 100cm visual analog scale
|
2 hours
|
|
Palatability using a 100cm visual analog scale
Time Frame: 12 minutes
|
differences in subject-rated palatability using a 100cm visual analog scale
|
12 minutes
|
|
Gastrointestinal Symptoms using a questionnaire
Time Frame: 2 hours
|
differences in subject-rated gastrointestinal symptom questionnaire
|
2 hours
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Francesca Scazzina, PhD, Department of Food and Drug, University of Parma
- Study Director: Furio Brighenti, PhD, Department of Food and Drug, University of Parma
Publications and helpful links
General Publications
- 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. Erratum In: N Engl J Med. 2014 Feb 27;370(9):886.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: J Nutr. 2006 Dec;136(12):3084.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Study Start
Primary Completion (ACTUAL)
Primary Completion
Study Completion (ACTUAL)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ACTUAL)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- Pasta+Sauces
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dietary Modification
-
NCT02669472CompletedDietary Habits | Dietary Modification
-
NCT03897972UnknownDietary Habits | Dietary Modification
-
NCT03250858CompletedDietary Habits | Dietary Modification
-
NCT03710200Completed
-
NCT03098017Completed
-
NCT03104686Completed
-
NCT02591329CompletedDietary Modification
-
NCT03021694CompletedDietary Modification
-
NCT02675348CompletedDietary Modification
-
NCT03024983Completed
Clinical Trials on Glucose #1
-
NCT04288518Completed
-
NCT05062460Completed
-
NCT04292626CompletedHodgkin Lymphoma, Adult | Non-Hodgkin Lymphoma, Adult
-
NCT03646812Completed
-
NCT02009514CompletedType 2 Diabetes Mellitus | End-Stage Kidney Disease
-
NCT03273881RecruitingPregnancy in Diabetics | Obstetric Labor
-
NCT04228341CompletedObesity | Diabetes Mellitus
-
NCT07475390Active, not recruitingGlioma (Any Grade) in the Brain