Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT02873858
Status:
COMPLETED
Last Update Posted:
2016-08-22
First Post:
2016-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Elucidation of Sensory Characteristics and Food Preferences in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012903', 'term': 'Smell'}], 'ancestors': [{'id': 'D012677', 'term': 'Sensation'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 611}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-16', 'studyFirstSubmitDate': '2016-08-04', 'studyFirstSubmitQcDate': '2016-08-16', 'lastUpdatePostDateStruct': {'date': '2016-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Indeed the level of dependency of scores at each of the olfactory tests, gustatory and masticatory', 'timeFrame': 'Day 1'}]}, 'conditionsModule': {'keywords': ['elderly'], 'conditions': ['Malnutrition']}, 'descriptionModule': {'briefSummary': 'Malnutrition is a frequent problem in persons older than 65 years: the prevalence of malnutrition can reach 25 to 29% in persons living at home who require help, figures vary between 19 and 38% for those living in institutions, and finally, the prevalence of malnutrition in hospitalized elderly patients can reach 30 to 90%. A few studies have attempted to explain modifications in attitudes, behaviour, the frequency of meals or nutritional status in the elderly by a fall in chemosensory sensitivity The aim of this project is to test the hypothesis that perhaps it is not as much the capacity to perceive a smell or a taste that affects eating behaviour in the elderly as their ability to distinguish between smells or tastes on the one hand (perceptual processing), and their ability to correctly interpret a chemosensory signal on the other (cognitive processing).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persons older than 65 years.\n* Persons with diabetes, heart disease or hypertension stabilized by a treatment.\n* Persons cognitively able to carry out the tests and fill in the questionnaires (Folstein test between 22 and 30).\n\nExclusion Criteria:\n\n* Any person suffering from an acute disease at the time of the test.\n* Any person presenting any allergy whatsoever (food, mites, pollen…).\n* Any person suffering from asthma or severe respiratory disorders (lung cancer, tracheotomy…).\n* Any person presenting anosmia (total loss of olfaction) from birth or following physical trauma (head injury) or due to disease (severe rhinitis).\n* Persons with diabetes, heart disease or hypertension not stabilized by treatment.\n* Any person presenting life expectancy of less than 6 months.'}, 'identificationModule': {'nctId': 'NCT02873858', 'acronym': 'AUPALESENS', 'briefTitle': 'Elucidation of Sensory Characteristics and Food Preferences in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Elucidation of Sensory Characteristics and Food Preferences in the Elderly', 'orgStudyIdInfo': {'id': 'PFITZENMEYER 2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1.independent patients', 'interventionNames': ['Other: smell and taste tests']}, {'type': 'EXPERIMENTAL', 'label': '2. less mobile patients', 'interventionNames': ['Other: smell and taste tests']}, {'type': 'EXPERIMENTAL', 'label': 'patient in a residence', 'interventionNames': ['Other: smell and taste tests']}, {'type': 'EXPERIMENTAL', 'label': 'patients in a home for the elderly (EHPAD)', 'interventionNames': ['Other: smell and taste tests']}], 'interventions': [{'name': 'smell and taste tests', 'type': 'OTHER', 'armGroupLabels': ['1.independent patients', '2. less mobile patients', 'patient in a residence', 'patients in a home for the elderly (EHPAD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}