Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-03-16 @ 7:06 PM
Study NCT ID:
NCT01684332
Status:
COMPLETED
Last Update Posted:
2012-09-19
First Post:
2012-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postprandial Response to Different Jams
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-18', 'studyFirstSubmitDate': '2012-09-10', 'studyFirstSubmitQcDate': '2012-09-11', 'lastUpdatePostDateStruct': {'date': '2012-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma malondialdehyde (MDA) postprandial measure', 'timeFrame': 'up to 120 minutes', 'description': 'Plasma MDA measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam'}], 'secondaryOutcomes': [{'measure': 'Serum glucose postprandial concentration', 'timeFrame': 'Baseline, 30, 60, 90 and 120 minutes', 'description': 'Serum Glucose measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam'}, {'measure': 'Serum insulin postprandial concentration', 'timeFrame': 'baseline, 30, 60, 90 and 120 minutes', 'description': 'Serum insulin measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam'}, {'measure': 'HOMA insulin resistance index', 'timeFrame': 'Baseline, 30, 60, 90 and 120 minutes', 'description': 'HOMA-IR calculated at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam'}, {'measure': 'Serum total cholesterol postprandial concentration', 'timeFrame': 'Baseline, 30, 60, 90 and 120 minutes', 'description': 'Serum total cholesterol measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam'}, {'measure': 'Serum HDL-cholesterol postprandial concentration', 'timeFrame': 'Baseline, 30, 60, 90 and 120 minutes', 'description': 'Serum HDL-cholesterol measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam'}, {'measure': 'Serum LDL-cholesterol postprandial concentration', 'timeFrame': 'Baseline, 30, 60, 90 and 120 minutes', 'description': 'Serum LDL-cholesterol calculated at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam'}, {'measure': 'Serum Uric Acid postprandial concentration', 'timeFrame': 'Baseline, 30, 60, 90 and 120 minutes', 'description': 'Serum Uric Acid measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam'}, {'measure': 'Plasma Glutathione Peroxidase postprandial activity', 'timeFrame': 'Baseline, 30, 60, 90 and 120 minutes', 'description': 'Plasma Glutathione Peroxidase activity measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam'}, {'measure': 'Postprandial Plasma Total Antioxidant Capacity', 'timeFrame': 'Baseline, 30, 60, 90 and 120 minutes', 'description': 'Plasma Total Antioxidant capacity measured at baseline and each 30 minutes during 2 hours after consuming 60 g of the experimental jam'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Antioxidant', 'glucose metabolism', 'jam', 'polyphenols', 'postprandial', 'strawberry'], 'conditions': ['Postprandial', 'Hyperglycemia, Postprandial', 'Feeding Behaviors', 'Antioxidant', 'Lipid Profile']}, 'referencesModule': {'references': [{'pmid': '23553051', 'type': 'DERIVED', 'citation': 'Ibero-Baraibar I, Cuervo M, Navas-Carretero S, Abete I, Zulet MA, Martinez JA. Different postprandial acute response in healthy subjects to three strawberry jams varying in carbohydrate and antioxidant content: a randomized, crossover trial. Eur J Nutr. 2014 Feb;53(1):201-10. doi: 10.1007/s00394-013-0517-7. Epub 2013 Apr 4.'}], 'seeAlsoLinks': [{'url': 'http://www.unav.es', 'label': 'University of Navarra'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effects of an acute intake of three different types of strawberry jam, differing in the carbohydrates and antioxidants content, on postprandial glucose metabolism, lipid profile, antioxidant status and satiety indices, in healthy adults.', 'detailedDescription': 'Study Design: Randomized, postprandial, crossover, double-blind intervention with three arms.\n\nSubjects: Sixteen healthy adults\n\nProduct studied: At each arm, participants consume 60g of strawberry jam:\n\n* High-sugar jam (traditional; HS),\n* Low-sugar jam (without added-sugar; LS),\n* Low-sugar jam including antioxidant extract from strawberry pulp (LSA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult men and women\n* Normal weight or overweight (BMI between 18.5 and 29.9 kg/m2)\n* Age between 20 and 50 years old.\n\nExclusion Criteria:\n\n* To suffer from any chronic disease related to metabolism,\n* To follow concomitant medications,\n* To follow slimming treatments or hormone replacement therapy,\n* To have any inability to perform the follow-up,\n* Smoking,\n* Known food allergies,\n* Pregnancy, lactation or menopause'}, 'identificationModule': {'nctId': 'NCT01684332', 'briefTitle': 'Postprandial Response to Different Jams', 'organization': {'class': 'OTHER', 'fullName': 'Clinica Universidad de Navarra, Universidad de Navarra'}, 'officialTitle': 'Study of the Effects of Three Strawberry Jams, Differing in Carbohydrate and Antioxidant Content, on Postprandial Response in Healthy Subjects', 'orgStudyIdInfo': {'id': 'UNAV-078-2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Sugar (HS)', 'description': 'Study of the postprandial effects after consuming 60g of strawberry jam with high sugar content', 'interventionNames': ['Other: Strawberry Jam']}, {'type': 'EXPERIMENTAL', 'label': 'Low Sugar (LS)', 'description': 'Study of the postprandial effects after consuming 60g of strawberry jam with low sugar content', 'interventionNames': ['Other: Strawberry Jam']}, {'type': 'EXPERIMENTAL', 'label': 'Low Sugar + Antioxidant (LSA)', 'description': 'Study of the postprandial effects after consuming 60g of strawberry jam with low sugar content and an antioxidant extract from strawberry pulp', 'interventionNames': ['Other: Strawberry Jam']}], 'interventions': [{'name': 'Strawberry Jam', 'type': 'OTHER', 'armGroupLabels': ['High Sugar (HS)', 'Low Sugar (LS)', 'Low Sugar + Antioxidant (LSA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Department of Nutrition, Food Science and Physiology', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}], 'overallOfficials': [{'name': 'J. Alfredo Martínez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Navarra'}, {'name': 'M. Ángeles Zulet, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Navarra'}, {'name': 'Marta Cuervo, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Navarra'}, {'name': 'Santiago Navas-Carretero, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Navarra'}, {'name': 'Idoia Ibero-Baraibar, MsC', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Navarra'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinica Universidad de Navarra, Universidad de Navarra', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Nutrition and Food Science', 'investigatorFullName': 'Alfredo Martinez', 'investigatorAffiliation': 'Clinica Universidad de Navarra, Universidad de Navarra'}}}}