Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2026-07-03 @ 12:40 PM
Study NCT ID:
NCT02702934
Status:
COMPLETED
Last Update Posted:
2017-08-10
First Post:
2016-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Effects of High-amylose Wheat-based Rusks.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006943', 'term': 'Hyperglycemia'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-09', 'studyFirstSubmitDate': '2016-03-02', 'studyFirstSubmitQcDate': '2016-03-03', 'lastUpdatePostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood glucose', 'timeFrame': '4 hours', 'description': 'Incremental area under the curve'}], 'secondaryOutcomes': [{'measure': 'Blood insulin', 'timeFrame': '4 hours', 'description': 'Incremental area under the curve'}, {'measure': 'Intestinal fermentation', 'timeFrame': '4 hours', 'description': 'Incremental area under the curve'}, {'measure': 'Blood triglycerides', 'timeFrame': '4 hours', 'description': 'Incremental area under the curve'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hyperglycemia']}, 'descriptionModule': {'briefSummary': 'Amylose-amylopectin ratio may influence the rate of starch digestion. This randomized controlled study evaluated the postprandial metabolic effects of amylose-rich- wheat- based rusks in overweight subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overweight/obese;\n* 30-60 years.\n\nExclusion Criteria:\n\n* age \\<30 and \\>60 years;\n* fasting triglycerides ≥400 mg/dl;\n* fasting cholesterol \\>270 mg/dl;\n* cardiovascular events (myocardial infarction or stroke) during the 6 months prior to the study;\n* established diabetes mellitus or any chronic disease;\n* renal and liver failure (creatinine \\>1.7 mg/dl and transaminases \\>2 times than normal values, respectively);\n* anaemia (Hb \\<12 g /dl);\n* any chronic disease.'}, 'identificationModule': {'nctId': 'NCT02702934', 'briefTitle': 'Metabolic Effects of High-amylose Wheat-based Rusks.', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Metabolic Effects of High-amylose Wheat-based Rusks in Healthy Subjects. A Pilot Study.', 'orgStudyIdInfo': {'id': '233/14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-amylose rusks', 'description': 'Test meal with 100g of carbohydrates coming from high-amylose rusks', 'interventionNames': ['Other: Test meal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control rusks', 'description': 'Test meal with 100g of carbohydrates coming from regular rusks used as control', 'interventionNames': ['Other: Test meal']}], 'interventions': [{'name': 'Test meal', 'type': 'OTHER', 'otherNames': ['Acute test meal'], 'description': 'Participants received in random order a test meal (900Kcal, 100g carbohydrates) containing rusks prepared with amylose-rich wheat flour or conventional flour. Blood samples were collected at fasting and every 30 minutes over 4 hours. Breath hydrogen was evaluated as a marker of intestinal fermentation. Participants underwent Visual Analogue Scale to assess subjective appetite sensations.', 'armGroupLabels': ['Control rusks', 'High-amylose rusks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80131', 'city': 'Naples', 'country': 'Italy', 'facility': 'Department of Clinical Medicine and Surgery', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'overallOfficials': [{'name': 'Angela Rivellese, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federico II University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'rivellese angela', 'investigatorAffiliation': 'Federico II University'}}}}