Dietary ModificationNCT03104712
A Trial on the GI of Spaghetti Versus Rice as Mixed Meals
A study testing Glucose #1, Glucose #2 and Glucose #3 in people with Dietary Modification, run by University of Parma at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification
- What is being tested?
- Glucose #1, Glucose #2 and Glucose #3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteItaly
- Study dates
- 27 Apr 2017to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- generally healthy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Dietary Modification
- Being tested
- Glucose #1, Glucose #2, Glucose #3, Spaghetti, Rice
- Keywords
- glycemic index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose #1Other
Also called Glucose Monohydrate
50g available carbohydrate
Glucose #2Other
Also called Glucose Monohydrate
50g available carbohydrate
Glucose #3Other
Also called Glucose Monohydrate
50g available carbohydrate
SpaghettiOther
50g available carbohydrate
RiceOther
Also called white rice
50g available carbohydrate
Spaghetti + Tomato SauceOther
50g available carbohydrate
Rice + Tomato SauceOther
Also called white rice + tomato sauce
50g available carbohydrate
Spaghetti + PestoOther
50g available carbohydrate
Rice + PestoOther
Also called white rice + pesto
50g available carbohydrate
| Study group | Role | What they receive |
|---|---|---|
| Glucose #1 | Other | 50 grams of available carbohydrate from glucose monohydrate will be dissolved in 250mL water and consumed as a test meal Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Glucose #3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
Secondary outcomes (3)
Postprandial Insulin
postprandial response for plasma insulin (IAUC)
Measured: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
Postprandial C-peptide
postprandial response for plasma c-peptide (IAUC)
Measured: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
Peak Glucose
maximum value of postprandial glucose response
Measured: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start27 Apr 2017
- Primary completion12 Mar 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Dietary ModificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Scazzina Ph.D., University of Parma
- Investigators
- Francesca Scazzina, PhD, Principal investigator, Department of Food and Drug, University of ParmaFurio Brighenti, PhD, Study director, Department of Food and Drug, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104712
- Sponsor's protocol ID
- Pasta+Sauces
- Status last verified
- May 2018
- First submitted
- 27 Mar 2017
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23364002Barclay 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.
PubMed 18326601Mirrahimi 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.
PubMed 23316283Moghaddam 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.
PubMed 16988118Thomas 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.
PubMed 19160276Pironi 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.
PubMed 8359644Moran 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.
PubMed 14715515Horowitz 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.
PubMed 8405758Rayner 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.
PubMed 11213895Estruch 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.
PubMed 23432189Esposito 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.
PubMed 26260349Anderson 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.
PubMed 27712954Canadian 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.
PubMed 24070963Evert 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.
PubMed 24107659American 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.
PubMed 25537702
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03104712
- Acronym / sponsor ID
- Pasta+Sauces
- Conditions
- Dietary Modification
- Keywords
- glycemic index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 12 Mar 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 7 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Glucose #1 | Other | Other: Glucose #150 grams of available carbohydrate from glucose monohydrate will be dissolved in 250mL water and consumed as a test meal |
| Spaghetti | Active comparator | Other: Spaghetti50 grams of available carbohydrate from spaghetti will be cooked according to package instructions and consumed as a test meal |
| Rice | Active comparator | Other: Rice50 grams of available carbohydrate from white rice will be cooked according to package instructions and consumed as a test meal |
| Spaghetti + tomato sauce | Active comparator | Other: Spaghetti + Tomato Sauce50 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 |
| Rice + tomato sauce | Active comparator | Other: Rice + Tomato Sauce50 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 |
| Spaghetti + Pesto | Active comparator | Other: Spaghetti + Pesto50 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 |
| Rice + Pesto | Active comparator | Other: Rice + Pesto50 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 |
| Glucose #2 | Other | Other: Glucose #250 grams of available carbohydrate from glucose monohydrate will be dissolved in 250mL water and consumed as a test meal |
| Glucose #3 | Other | Other: Glucose #350 grams of available carbohydrate from glucose monohydrate will be dissolved in 250mL water and consumed as a test meal |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- generally healthy
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose #1Also: Glucose Monohydrate50g available carbohydrate | Other | Glucose #1 |
| Glucose #2Also: Glucose Monohydrate50g available carbohydrate | Other | Glucose #2 |
| Glucose #3Also: Glucose Monohydrate50g available carbohydrate | Other | Glucose #3 |
| Spaghetti50g available carbohydrate | Other | Spaghetti |
| RiceAlso: white rice50g available carbohydrate | Other | Rice |
| Spaghetti + Tomato Sauce50g available carbohydrate | Other | Spaghetti + tomato sauce |
| Rice + Tomato SauceAlso: white rice + tomato sauce50g available carbohydrate | Other | Rice + tomato sauce |
| Spaghetti + Pesto50g available carbohydrate | Other | Spaghetti + Pesto |
| Rice + PestoAlso: white rice + pesto50g available carbohydrate | Other | Rice + Pesto |
Primary outcome
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)
3 secondary outcomes
Postprandial Insulin
Time frame: 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)
Peak Glucose
Time frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Background: PubMed 23364002Ajala 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.
- Background: PubMed 18326601Barclay 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.
- Background: PubMed 23316283Mirrahimi 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.
- Background: PubMed 16988118Moghaddam 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.
- Background: PubMed 19160276Thomas 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.
- Background: PubMed 8359644Pironi 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.
- Background: PubMed 14715515Moran 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.
- Background: PubMed 8405758Horowitz 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.
- Background: PubMed 11213895Rayner 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.
- Background: PubMed 23432189Estruch 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.
- Background: PubMed 26260349Esposito 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.
- Background: PubMed 27712954Anderson 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.
- Individual participant dataSharing planned: No
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Liver Health
Active, not recruiting
Effects of an Anti-Inflammatory Diet on Inflammatory and Neuroendocrine Responses After Lumbar Discectomy
Lumbar Discectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesca Scazzina, PhD principal investigator
Department of Food and Drug, University of Parma
Furio Brighenti, PhD study director
Department of Food and Drug, University of Parma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose #1, Glucose #2 and Glucose #3 in people with Dietary Modification, run by University of Parma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Index (time frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03104712, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.