An interventional study of High Pasta and Low Pasta in Diet Therapy, sponsored by University of Parma. Completed at 1 site in Italy. Open to participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-04.
Sponsored by University of Parma · Not applicable, Interventional, and Treatment
Among 340 studies in Obesity with a site in Italy — 97 open to participants now, 116 under way, 28 of them phase 3. Obesity · Italy.
Among the 340 studies in Obesity with a site in Italy, this one is the 162nd largest by planned enrollment of the 227 interventional ones that give a count, is one of 15 that started in 2015, is one of 155 with no phase, and was the 96th registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
Browse Obesity studies →97 of the 340 studies in Obesity with a site in Italy are open now. Recruiting first, the newest first:
Eli Lilly and Company · Sites in Italy, United States, Belgium and 7 more countries
Azienda Ospedaliero Universitaria Maggiore della Carita · Sites in Italy
Istituti Clinici Scientifici Maugeri SpA · Sites in Italy
AstraZeneca · Sites in Italy, United States, Argentina and 13 more countries
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis · Sites in Italy
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 20 Years to 55 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
340 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 9 · Phase 3 49 · Phase 4 15
First in 1999; this study’s year is marked. 15 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 44 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Median enrollment 90 across the 227 interventional studies, 120 across the 112 observational. Of the 183 that completed or were terminated, 14 (8%) have results posted.
This tab as a report to print or save as PDF → With an account.
74 of 340 have an industry lead sponsor. The 10 most frequent:
University of Parma is the lead sponsor of 77 studies on the registry; 8 are open to participants now.
University of Parma has 4 studies filed under Obesity — fewer than ten, so there is no comparison to draw.
25 of the studies in Obesity with a site in Italy that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06914895Phase 3Eli Lilly and CompanyA Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT06858839Phase 3AmgenEvaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight | 2027-01-21 |
| NCT06858878Phase 3AmgenEfficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight | 2027-01-21 |
| NCT06672549Phase 3Eli Lilly and CompanyA Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040) | 2027-02 |
| NCT07220642Phase 3Novo Nordisk A/SWeight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide | 2027-05-11 |
Among the 340 studies in Obesity with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
To the best of our knowledge, the effect of pasta consumption within a hypocaloric Mediterranean diet has only been scarcely explored yet. Therefore, a two-parallel group dietary intervention was carried out to investigate if pasta consumption could affect the BMI change in obese patients. The primary outcome was the loss of at leat 8% of the initial body weight in the first 6 months. Anthropometric and body composition (from bioelectrical impedance analysis - BIA-) measures were collected every month for the first 6 months and after 1 year. In addition, dietary information was collected at baseline and after 3, 6 and 12 months through a 7-day carbohydrate food record and a 24-h food recall. Blood samples were collected at baseline and at 6 and 12 months to assess: glucose, insulin, Homeostatic model assessment for insulin resistant (HOMA-IR) index, total cholesterol, low-density lipoprotein, high-density lipoprotein, and uric acid. Furthermore, the perceived quality of life was investigated through the 36-items short form health survey (SF36) questionnaire.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 44 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →University of Parma is the lead sponsor of 77 studies on the registry; 8 are open to participants now.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Weight Loss. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Habitual pasta consumption equal or higher than 5 times/week.
Behavioral: High Pasta
Habitual pasta consumption equal or lower than 3 times/week.
Behavioral: Low Pasta
Participants received a personalised diet program considering their food preferences and eating behaviour, based on the Italian guidelines for a healthy and Mediterranean diet and were encouraged to maintain their habitual consumption of pasta (at least 5 times/week). To encourage participants to prepare healthy meals by using high-quality ingredients, participants were provided with a recipe book and dietary guidelines and recommendations.
Participants received a personalised diet program considering their food preferences and eating behaviour, based on the Italian guidelines for a healthy and Mediterranean diet and were encouraged to maintain their habitual consumption of pasta (no more than 3 times/week). To encourage participants to prepare healthy meals by using high-quality ingredients, participants were provided with a recipe book and dietary guidelines and recommendations.
Change from baseline Body weight at 6 months
Measured in kg according to the standard procedure
Time frame: baseline, 6 months
Change from baseline Body weight at 3 months
Measured in kg according to the standard procedure
Time frame: baseline, 3 months
Change from baseline Body weight at 12 months
Measured in kg according to the standard procedure
Time frame: baseline, 12 months
BMI
Calculated as body weight in kilograms divided by the square of the height in meters
Time frame: baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months
Waist circumference
Measured in cm according to the standard procedure
Time frame: baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months
Free Fat Mass
Estimated by bioelectrical impedance analysis in kg and in %
Time frame: baseline, 3 months, 6 months, 12 months
Fat Mass
Estimated by bioelectrical impedance analysis in kg and in %
Time frame: baseline, 3 months, 6 months, 12 months
Basal Metabolic Rate
Estimated by bioelectrical impedance analysis in kcal/day
Time frame: baseline, 3 months, 6 months, 12 months
Glucose
mg/dL in fasting condition
Time frame: baseline, 6 months, 12 months
Insulin
microU/mL in fasting condition
Time frame: baseline, 6 months, 12 months
HOMA-IR index
calculated from glucose and insulin in fasting condition
Time frame: baseline, 6 months, 12 months
Total cholesterol
mg/dL in fasting condition
Time frame: baseline, 6 months, 12 months
HDL cholesterol
mg/dL in fasting condition
Time frame: baseline, 6 months, 12 months
LDL cholesterol
mg/dL in fasting condition
Time frame: baseline, 6 months, 12 months
Triglycerides
mg/dL in fasting condition
Time frame: baseline, 6 months, 12 months
Uric Acid
mg/dL in fasting condition
Time frame: baseline, 6 months, 12 months
Energy intake
assessed by a 24-h dietary recall as kcal/day
Time frame: baseline, 3 months, 6 months, 12 months
Nutrient intakes
assessed by a 24-h dietary recall as g/day
Time frame: baseline, 3 months, 6 months, 12 months
Carbohydrate-based food intakes
assessed by a 7-day food diary as times/week
Time frame: baseline, 3 months, 6 months, 12 months
Perceived Quality of Life
assessed by the SF36 questionnaire
Time frame: baseline, 3 months, 6 months, 12 months
Plan to share: Undecided
Ran from Nov 2015 to primary completion in Dec 2017, 25 months.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 25 months is close to that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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University of Parma