Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2026-03-03 @ 10:02 PM
Study NCT ID:
NCT02842606
Status:
COMPLETED
Last Update Posted:
2017-08-10
First Post:
2016-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Response to the Acute Consumption of Fiber-enriched Pasta
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-09', 'studyFirstSubmitDate': '2016-07-15', 'studyFirstSubmitQcDate': '2016-07-20', 'lastUpdatePostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose and lipid response', 'timeFrame': '4 hours', 'description': 'Evaluated by enzymatic colorimetric methods'}], 'secondaryOutcomes': [{'measure': 'Insulin response', 'timeFrame': '4 hours', 'description': 'Evaluated by ELISA'}, {'measure': 'Hormone response (GLP-1, GIP, PYY and Ghrelin)', 'timeFrame': '4 hours', 'description': 'Evaluated by ELISA'}, {'measure': 'Energy intake in the subsequent meal.', 'timeFrame': '4 hours', 'description': 'Evaluated by food record'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'Cardio-metabolic diseases are a leading cause of mortality worldwide. Over the years, therefore, there have been considerable efforts to identify strategies for prevention and management of risk factors. The diet, with its pleiotropic effects, is one of the most effective approaches to reduce the cardio-metabolic risk. In this context, the dietary fibers have been extensively studied and the available evidence supports the beneficial effects of its consumption. However, worldwide the average fiber consumption is still less than the recommended daily dose. For this reason, the availability of functional foods, such as additional sources of fiber in the diet, may facilitate the attainment of fiber recommended.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 18-29 kg / m2\n* Good Health status\n\nExclusion Criteria:\n\n* Diabetes\n* Cardiovascular events (IMA or stroke) severe heart disease\n* Kidney or liver failure\n* Anemia and any other chronic disease'}, 'identificationModule': {'nctId': 'NCT02842606', 'acronym': 'PROPASTA', 'briefTitle': 'Metabolic Response to the Acute Consumption of Fiber-enriched Pasta', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Effects of the Consumption of Fiber-enriched Pasta on Glucose and Lipid Metabolism and Satiety', 'orgStudyIdInfo': {'id': '166/14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fiber-enriched pasta', 'description': 'The participants consume whole wheat pasta with added fiber (fiber 12 g fiber/100 g).', 'interventionNames': ['Other: Test meal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control pasta', 'description': 'The participants consume pasta made from durum wheat semolina (fiber 2.7g/100g).', 'interventionNames': ['Other: Test meal']}], 'interventions': [{'name': 'Test meal', 'type': 'OTHER', 'otherNames': ['Acute test meal'], 'description': 'The two test meals are designed to have the same energy and macronutrient composition. They differ only in the carbohydrate source: fiber-enriched pasta or control pasta. Blood samples are taken at fasting and every 30 minutes over 4 hours. Fasting and postprandial intestinal fermentation is evaluated by breath test.', 'armGroupLabels': ['Control pasta', 'Fiber-enriched pasta']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full professor', 'investigatorFullName': 'rivellese angela', 'investigatorAffiliation': 'Federico II University'}}}}