Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2026-02-09 @ 2:53 PM
Study NCT ID:
NCT03411603
Status:
COMPLETED
Last Update Posted:
2018-01-26
First Post:
2018-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Nutrient Profiling System for Reformulation
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': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6991}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-25', 'studyFirstSubmitDate': '2018-01-11', 'studyFirstSubmitQcDate': '2018-01-25', 'lastUpdatePostDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healthy Eating Index 2010', 'timeFrame': '2011-12', 'description': 'Measure of dietary quality for the NHANES Survey, based on reported dietary intakes'}, {'measure': 'PNNS-GS diet score', 'timeFrame': '2006-07', 'description': 'Measure of dietary quality for the French INCA2 Survey, based on reported dietary intakes'}], 'secondaryOutcomes': [{'measure': 'Mean Adequacy Ratio', 'timeFrame': '2006-07 and 2011-12', 'description': 'Measure of individuals nutrient adequacy based on reported food intakes'}, {'measure': 'Mean Excess Ratio', 'timeFrame': '2006-07 and 2011-12', 'description': 'Measure of excessive nutrient consumption, based on reported food intakes'}, {'measure': 'Energy density', 'timeFrame': '2006-07 and 2011-12', 'description': 'Solid energy density of diets, based on reported food intakes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nutrient profiling'], 'conditions': ['Nutrition Poor']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.anses.fr/en/content/inca-studies', 'label': 'Details of French dietary surveys. ANSES website'}]}, 'descriptionModule': {'briefSummary': 'The objectives of the study are to assess the validity of Nestlé reformulation criteria in two national dietary surveys: the US NHANES 2011, and the French INCA2 2006-07.', 'detailedDescription': 'Background: The Nestlé Nutritional Profiling System (NNPS) has been developed to guide food and beverage reformulation. It is not known whether products passing the NNPS standards have a higher overall nutritional density, and whether the higher consumption of NNPS Pass products is associated with a higher dietary quality.\n\nObjective: The objectives were (i) to compare the classifications derived from the NNPS and the validated UK Ofcom nutrient profiling system; and (ii) to assess the NNPS construct validity against healthy and unhealthy diets in French (Individual and National Survey on food Consumption 2006-2007) and the US (National Health and Nutrition Examination Surveys 2011-2012) nationally representative dietary surveys.\n\nDesign: NNPS outcomes (PASS, FAIL, Out-of-scope) of foods were compared to UK Ofcom outcomes. Contributions of NNPS outcomes to energy intakes were compared between diets nutritional quality classes defined by two methods: based on a food-based quality indicator (PNNS-GS in France, HEI-2010 in the US), or on a combination of three nutrient-based indicators (MAR, MER, energy density).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Representative samples of the US and French adult populations', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All participants of INCA2 and NHANES 2011-12 surveys\n\nExclusion Criteria:\n\n* Missing dietary intake data'}, 'identificationModule': {'nctId': 'NCT03411603', 'briefTitle': 'Validation of a Nutrient Profiling System for Reformulation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Food and Diet Based Validations of a Nutrient Profiling System for Reformulation in Two Nationally Representative Surveys', 'orgStudyIdInfo': {'id': 'AJCN/2017/172213'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'INCA2 2006-07', 'description': 'French National Dietary Intake Survey, conducted in 2006-2007 by the French Agency for Food, Environmental and Occupational Health Safety.\n\nAdults aged 18y and over, n=1918 included in the analyses.', 'interventionNames': ['Other: Diet and socio-demographic questionnaires']}, {'label': 'NHANES 2011-12', 'description': 'Wave 2011-12 of the National Health and Nutrition Examination Survey, the US national dietary intake Survey, conducted by the Centers for Disease Control and Prevention (CDC) Adults aged 18y and over, n=5073 included in the analyses.', 'interventionNames': ['Other: Diet and socio-demographic questionnaires']}], 'interventions': [{'name': 'Diet and socio-demographic questionnaires', 'type': 'OTHER', 'description': '24-hr recall or food diary questionnaires; socio-demographic questionnaires', 'armGroupLabels': ['INCA2 2006-07', 'NHANES 2011-12']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kathryn Porter', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centers for Disease Control and Prevention'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The NHANES 2011-12 and INCA2 data are available to other researchers via the respective websites.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}