Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-26 @ 11:41 PM
Study NCT ID:
NCT03341650
Status:
COMPLETED
Last Update Posted:
2018-05-04
First Post:
2017-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Pasta vs. Low Pasta Diet in the Treatment of Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-03', 'studyFirstSubmitDate': '2017-11-07', 'studyFirstSubmitQcDate': '2017-11-13', 'lastUpdatePostDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline Body weight at 6 months', 'timeFrame': 'baseline, 6 months', 'description': 'Measured in kg according to the standard procedure'}], 'secondaryOutcomes': [{'measure': 'Change from baseline Body weight at 3 months', 'timeFrame': 'baseline, 3 months', 'description': 'Measured in kg according to the standard procedure'}, {'measure': 'Change from baseline Body weight at 12 months', 'timeFrame': 'baseline, 12 months', 'description': 'Measured in kg according to the standard procedure'}, {'measure': 'BMI', 'timeFrame': 'baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months', 'description': 'Calculated as body weight in kilograms divided by the square of the height in meters'}, {'measure': 'Waist circumference', 'timeFrame': 'baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 12 months', 'description': 'Measured in cm according to the standard procedure'}, {'measure': 'Free Fat Mass', 'timeFrame': 'baseline, 3 months, 6 months, 12 months', 'description': 'Estimated by bioelectrical impedance analysis in kg and in %'}, {'measure': 'Fat Mass', 'timeFrame': 'baseline, 3 months, 6 months, 12 months', 'description': 'Estimated by bioelectrical impedance analysis in kg and in %'}, {'measure': 'Basal Metabolic Rate', 'timeFrame': 'baseline, 3 months, 6 months, 12 months', 'description': 'Estimated by bioelectrical impedance analysis in kcal/day'}, {'measure': 'Glucose', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'mg/dL in fasting condition'}, {'measure': 'Insulin', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'microU/mL in fasting condition'}, {'measure': 'HOMA-IR index', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'calculated from glucose and insulin in fasting condition'}, {'measure': 'Total cholesterol', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'mg/dL in fasting condition'}, {'measure': 'HDL cholesterol', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'mg/dL in fasting condition'}, {'measure': 'LDL cholesterol', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'mg/dL in fasting condition'}, {'measure': 'Triglycerides', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'mg/dL in fasting condition'}, {'measure': 'Uric Acid', 'timeFrame': 'baseline, 6 months, 12 months', 'description': 'mg/dL in fasting condition'}, {'measure': 'Energy intake', 'timeFrame': 'baseline, 3 months, 6 months, 12 months', 'description': 'assessed by a 24-h dietary recall as kcal/day'}, {'measure': 'Nutrient intakes', 'timeFrame': 'baseline, 3 months, 6 months, 12 months', 'description': 'assessed by a 24-h dietary recall as g/day'}, {'measure': 'Carbohydrate-based food intakes', 'timeFrame': 'baseline, 3 months, 6 months, 12 months', 'description': 'assessed by a 7-day food diary as times/week'}, {'measure': 'Perceived Quality of Life', 'timeFrame': 'baseline, 3 months, 6 months, 12 months', 'description': 'assessed by the SF36 questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mediterranean Diet', 'BMI', 'weight loss', 'pasta', 'obesity'], 'conditions': ['Diet Therapy']}, 'referencesModule': {'references': [{'pmid': '32402585', 'type': 'DERIVED', 'citation': "Rosi A, Tesan M, Cremonini A, Biasini B, Bicchieri L, Cossu M, Brighenti F, Dall'Aglio E, Scazzina F. Body weight of individuals with obesity decreases after a 6-month high pasta or low pasta Mediterranean diet weight-loss intervention. Nutr Metab Cardiovasc Dis. 2020 Jun 9;30(6):984-995. doi: 10.1016/j.numecd.2020.02.013. Epub 2020 Feb 24."}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 30-45 kg/m2\n* healthy subjects\n* regular meal consumption\n* no celiac disease\n* no menopause woman\n\nExclusion Criteria:\n\n* with a BMI \\<30 or \\>45 kg/m2\n* having diabetes, hepatic or kidney diseases\n* having an eating disorder\n* having celiac disease\n* menopause woman'}, 'identificationModule': {'nctId': 'NCT03341650', 'briefTitle': 'High Pasta vs. Low Pasta Diet in the Treatment of Obesity', 'organization': {'class': 'OTHER', 'fullName': 'University of Parma'}, 'officialTitle': 'The Effect of High Pasta vs. Low Pasta Mediterranean Diet on Weight Loss in the Treatment of Obese Patients', 'orgStudyIdInfo': {'id': 'SP2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Pasta', 'description': 'Habitual pasta consumption equal or higher than 5 times/week.', 'interventionNames': ['Behavioral: High Pasta']}, {'type': 'EXPERIMENTAL', 'label': 'Low Pasta', 'description': 'Habitual pasta consumption equal or lower than 3 times/week.', 'interventionNames': ['Behavioral: Low Pasta']}], 'interventions': [{'name': 'High Pasta', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['High Pasta']}, {'name': 'Low Pasta', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Low Pasta']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43125', 'city': 'Parma', 'country': 'Italy', 'facility': 'Department of Food and Drug, University of Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}], 'overallOfficials': [{'name': "Elisabetta Dall'Aglio, MD", 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Parma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Parma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Francesca Scazzina Ph.D.', 'investigatorAffiliation': 'University of Parma'}}}}