Dietary ModificationNCT03024983
Pasta and Other Durum Wheat-based Products: Effects on Post-prandial Glucose Metabolism
A study testing Glucose, Semolina soup and Bread in people with Dietary Modification, run by University of Parma at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification
- What is being tested?
- Glucose, Semolina soup and Bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2015to Jul 2016
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male and female (age ≥ 18 years)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
The different glycemic responses after the consumption of carbohydrate-based products are associated with different rates of digestion and absorption of the carbohydrates in the human body. Therefore, food products rich in carbohydrates can be classified based on their ability to be digested, absorbed and to affect post-prandial glycemia. Epidemiological studies suggest that following a diet including carbohydrate-based foods inducing a low and slow glycemic response is associated with reduced risk to develop some non-communicable diseases (such as type 2 diabetes (Livesey et al, 2013; Dong et al, 2011) and cardiovascular disease (Ludwig, 2002; Blaak et al, 2012)), to control inflammatory status (Ma et al, 2012; Sieri et al, 2010), which is the trigger of several pathologies, and to reduce fasting insulin (Schwingshackl \& Hoffmann, 2013). Depending on the food composition, a low glycemic response is not always associated with a low plasma insulin concentration. For instance, high protein or lipid concentrations in the food matrix have been demonstrated to induce low post-prandial glycemic responses, but not a reduction in insulin secretion (Gannon et al, 1988; Gannon et al, 1993; Collier et al. 1988). Avoiding a high insulin post-prandial response after consumption of foods represents a preventive factor against the risk of overweight and hyperlipidemia (Ostlund et al, 1990), type 2 diabetes (Weyer et al, 2001), and cancer (Onitilo et al, 2014). Therefore, the evaluation of both glycemic and insulinemic post-prandial response curves is necessary in order to demonstrate the true beneficial effect of the consumption of low glycemic index foods. Among several factors which can influence the post-prandial glycemic and insulinemic responses (such as macronutrient composition and the cooking process), the technological aspects through which the foods are produced represent an important one. Several studies reported a low glycemic response after the consumption of pasta compared with bread (Jenkins et al, 1988; Jenkins et al, 1981; Wolever et al, 1986), and this is due to the technological structures characterizing the two matrices (Petitot et al, 2009). Pasta is one of the major sources of carbohydrates consumed in Italy. Therefore, the aim of the present study is to investigate the effect of pasta and other durum wheat based products on the plasma response of glucose, insulin, and other hormones related to the glucose metabolism (c-peptide, GLP-1 and GIP) in order to clearly discriminate the different biological effect induced by the technological process in the production of pasta, compared to foods beginning with the same ingredients. Moreover, the study aims to create a solid basis for future studies for evaluating the effect of pasta consumption, as the main source of carbohydrates, in a context of a balanced diet, for maintaining health.
- Conditions
- Dietary Modification
- Being tested
- Glucose, Semolina soup, Bread, Penne (fresh), Penne (dry)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucoseOther
Glucose monohydrate (55 g) dissolved with 500 mL of water
Semolina soupOther
Semolina soup (322 g) eaten with 500 mL of water
BreadOther
Bread (122 g) eaten with 500 mL of water
Penne (fresh)Other
Cooked penne (132 g) eaten with 500 mL of water
Penne (dry)Other
Cooked penne (142 g) eaten with 500 mL of water
Spaghetti (dry)Other
Cooked spaghetti (142 g) eaten with 500 mL of water
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Glucose monohydrate (isoglucidic portion -50 g of available carbohydrates-) Receives: Other: Glucose |
| Semolina | Experimental | Semolina soup (isoglucidic portion -50 g of available carbohydrates-) Receives: Other: Semolina soup |
| Bread | Experimental | Bread (isoglucidic portion -50 g of available carbohydrates-) Receives: Other: Bread |
| Short pasta (fresh) | Experimental | Fresh penne (isoglucidic portion -50 g of available carbohydrates-) Receives: Other: Penne (fresh) |
| Short pasta (dry) | Experimental | Short pasta (dry) (isoglucidic portion -50 g of available carbohydrates-) Receives: Other: Penne (dry) |
| Long pasta (dry) | Experimental | Long pasta (dry) (isoglucidic portion -50 g of available carbohydrates-) Receives: Other: Spaghetti (dry) |
What is being measured
The primary outcome is the main question the study is designed to answer.
incremental area under the curve for plasma glucose
Measured: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
Secondary outcomes (5)
post-prandial insulin plasma concentration
Measured: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
post-prandial c-peptide plasma concentration
Measured: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
post-prandial GLP-1 plasma concentration
Measured: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
post-prandial GIP plasma concentration
Measured: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
post-prandial glucagon plasma concentration
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 posted19 Jan 2017 (estimated)
- Study startSep 2015
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)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
- None (open label)
- Enrolment
- 18 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, Professor, Principal investigator, Department of Food Science, University of ParmaFurio Brighenti, Professor, Study director, Department of Food Science, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024983
- Sponsor's protocol ID
- DWP1
- Status last verified
- Jan 2017
- First submitted
- 16 Jan 2017
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 22780564Collier 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.
PubMed 3276722Dong 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.
PubMed 22017823Gannon 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.
PubMed 3054432Jenkins 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.
PubMed 3383733Jenkins 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.
PubMed 6259925Livesey 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.
PubMed 23364021Ludwig 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.
PubMed 11988062Ma 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.
PubMed 22727193Onitilo 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.
PubMed 23962874Ostlund 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.
PubMed 2403660Petitot, 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
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.
PubMed 23786819Sieri 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.
PubMed 20386010Weyer 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.
PubMed 11344187
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pasta and Other Durum Wheat-based Products: Effects on Post-prandial Glucose Metabolism
- ClinicalTrials.gov ID
- NCT03024983
- Acronym / sponsor ID
- DWP1
- Conditions
- Dietary Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 19 Jan 2017 (estimated)
- 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.
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).
Detailed description
The different glycemic responses after the consumption of carbohydrate-based products are associated with different rates of digestion and absorption of the carbohydrates in the human body. Therefore, food products rich in carbohydrates can be classified based on their ability to be digested, absorbed and to affect post-prandial glycemia. Epidemiological studies suggest that following a diet including carbohydrate-based foods inducing a low and slow glycemic response is associated with reduced risk to develop some non-communicable diseases (such as type 2 diabetes (Livesey et al, 2013; Dong et al, 2011) and cardiovascular disease (Ludwig, 2002; Blaak et al, 2012)), to control inflammatory status (Ma et al, 2012; Sieri et al, 2010), which is the trigger of several pathologies, and to reduce fasting insulin (Schwingshackl \& Hoffmann, 2013). Depending on the food composition, a low glycemic response is not always associated with a low plasma insulin concentration. For instance, high protein or lipid concentrations in the food matrix have been demonstrated to induce low post-prandial glycemic responses, but not a reduction in insulin secretion (Gannon et al, 1988; Gannon et al, 1993; Collier et al. 1988). Avoiding a high insulin post-prandial response after consumption of foods represents a preventive factor against the risk of overweight and hyperlipidemia (Ostlund et al, 1990), type 2 diabetes (Weyer et al, 2001), and cancer (Onitilo et al, 2014). Therefore, the evaluation of both glycemic and insulinemic post-prandial response curves is necessary in order to demonstrate the true beneficial effect of the consumption of low glycemic index foods. Among several factors which can influence the post-prandial glycemic and insulinemic responses (such as macronutrient composition and the cooking process), the technological aspects through which the foods are produced represent an important one. Several studies reported a low glycemic response after the consumption of pasta compared with bread (Jenkins et al, 1988; Jenkins et al, 1981; Wolever et al, 1986), and this is due to the technological structures characterizing the two matrices (Petitot et al, 2009). Pasta is one of the major sources of carbohydrates consumed in Italy. Therefore, the aim of the present study is to investigate the effect of pasta and other durum wheat based products on the plasma response of glucose, insulin, and other hormones related to the glucose metabolism (c-peptide, GLP-1 and GIP) in order to clearly discriminate the different biological effect induced by the technological process in the production of pasta, compared to foods beginning with the same ingredients. Moreover, the study aims to create a solid basis for future studies for evaluating the effect of pasta consumption, as the main source of carbohydrates, in a context of a balanced diet, for maintaining health.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: GlucoseGlucose monohydrate (isoglucidic portion -50 g of available carbohydrates-) |
| Semolina | Experimental | Other: Semolina soupSemolina soup (isoglucidic portion -50 g of available carbohydrates-) |
| Bread | Experimental | Other: BreadBread (isoglucidic portion -50 g of available carbohydrates-) |
| Short pasta (fresh) | Experimental | Other: Penne (fresh)Fresh penne (isoglucidic portion -50 g of available carbohydrates-) |
| Short pasta (dry) | Experimental | Other: Penne (dry)Short pasta (dry) (isoglucidic portion -50 g of available carbohydrates-) |
| Long pasta (dry) | Experimental | Other: Spaghetti (dry)Long pasta (dry) (isoglucidic portion -50 g of available carbohydrates-) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy male and female (age ≥ 18 years)
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| GlucoseGlucose monohydrate (55 g) dissolved with 500 mL of water | Other | Control |
| Semolina soupSemolina soup (322 g) eaten with 500 mL of water | Other | Semolina |
| BreadBread (122 g) eaten with 500 mL of water | Other | Bread |
| Penne (fresh)Cooked penne (132 g) eaten with 500 mL of water | Other | Short pasta (fresh) |
| Penne (dry)Cooked penne (142 g) eaten with 500 mL of water | Other | Short pasta (dry) |
| Spaghetti (dry)Cooked spaghetti (142 g) eaten with 500 mL of water | Other | Long pasta (dry) |
Primary outcome
incremental area under the curve for plasma glucose
Time frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
5 secondary outcomes
post-prandial insulin plasma concentration
Time frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
post-prandial c-peptide plasma concentration
Time frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
post-prandial GLP-1 plasma concentration
Time frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
post-prandial GIP plasma concentration
Time frame: 2 hours (-10 and 0 -fasting-, 15, 30, 45, 60, 90, 120 minutes)
post-prandial glucagon plasma concentration
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 19 Jan 2017.
- Background: PubMed 22780564Blaak 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.
- Background: PubMed 3276722Collier 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.
- Background: PubMed 22017823Dong 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.
- Background: PubMed 3054432Gannon 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.
- Background: PubMed 3383733Jenkins 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.
- Background: PubMed 6259925Jenkins 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.
- Background: PubMed 23364021Livesey 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.
- Background: PubMed 11988062Ludwig 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.
- Background: PubMed 22727193Ma 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.
- Background: PubMed 23962874Onitilo 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.
- Background: PubMed 2403660Ostlund 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.
- BackgroundPetitot, 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
- Individual participant dataSharing planned: No
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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, Professor principal investigator
Department of Food Science, University of Parma
Furio Brighenti, Professor study director
Department of Food Science, 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, Semolina soup and Bread 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 6 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 19 Jan 2017. 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?
incremental area under the curve for plasma glucose (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 NCT03024983, which also lists 16 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 19 Jan 2017.