Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2025-12-25 @ 9:19 PM
Study NCT ID:
NCT01615159
Status:
COMPLETED
Last Update Posted:
2022-10-28
First Post:
2012-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maintenance of Recommended Sodium Intake
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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-27', 'studyFirstSubmitDate': '2012-04-16', 'studyFirstSubmitQcDate': '2012-06-06', 'lastUpdatePostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in urinary sodium excretion', 'timeFrame': 'Weeks 4, 24'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in preferences for level of sodium in food products', 'timeFrame': 'Weeks 4, 24'}, {'measure': 'Percentage of people below 2300 mg/day sodium intake', 'timeFrame': 'Weeks 4, 24'}, {'measure': 'Percentage of people below 1500 mg/day sodium intake', 'timeFrame': 'weeks 4, 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sodium', 'Diet', 'Urinary sodium excretion', 'Feeding study', 'Diet maintenance'], 'conditions': ['Maintenance of Recommended Sodium Intake']}, 'referencesModule': {'references': [{'pmid': '26269371', 'type': 'DERIVED', 'citation': 'Anderson CA, Cobb LK, Miller ER 3rd, Woodward M, Hottenstein A, Chang AR, Mongraw-Chaffin M, White K, Charleston J, Tanaka T, Thomas L, Appel LJ. Effects of a behavioral intervention that emphasizes spices and herbs on adherence to recommended sodium intake: results of the SPICE randomized clinical trial. Am J Clin Nutr. 2015 Sep;102(3):671-9. doi: 10.3945/ajcn.114.100750. Epub 2015 Aug 12.'}]}, 'descriptionModule': {'briefSummary': 'The overall objective of this study is to assist the general public in achieving and maintaining the currently recommended sodium intake of 1500 mg/day through a reduced sodium intervention that emphasizes spices and herbs. The investigators hypothesize that after four weeks of eating a controlled diet, individuals will acclimate and adhere to a reduced sodium intake of 1500 mg/day and their taste preferences will change. The investigators also hypothesize that individuals in a low sodium behavioral intervention will maintain greater adherence to a dietary sodium intake of ≤ 1500 mg/day than individuals in a self-directed control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults to whom the U.S. Dietary Guideline of \\< 1500 mg/day of sodium applies\n\nExclusion Criteria:\n\n* Individuals with chronic kidney disease,\n* Chronic poor health state,\n* Pregnancy,\n* Inability to complete feeding study,\n* Investigator discretion'}, 'identificationModule': {'nctId': 'NCT01615159', 'acronym': 'SPICE', 'briefTitle': 'Maintenance of Recommended Sodium Intake', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins Bloomberg School of Public Health'}, 'officialTitle': 'Maintenance of Recommended Sodium Intake', 'orgStudyIdInfo': {'id': 'JHSPH4135'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Self directed control'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Behavior and lifestyle counseling', 'interventionNames': ['Behavioral: Behavior and lifestyle counseling']}], 'interventions': [{'name': 'Behavior and lifestyle counseling', 'type': 'BEHAVIORAL', 'description': '20 week intervention period where one group gets behavior and lifestyle counseling and the other group gets no active intervention', 'armGroupLabels': ['Behavior and lifestyle counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Cheryl A Anderson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'McCormick Science Institute', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}