Ignite Creation Date:
2025-12-25 @ 12:30 AM
Ignite Modification Date:
2026-02-23 @ 3:01 PM
Study NCT ID:
NCT03024567
Status:
COMPLETED
Last Update Posted:
2022-07-11
First Post:
2017-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Study on Salt Intake and Energy Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012492', 'term': 'Salts'}], 'ancestors': [{'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-07', 'studyFirstSubmitDate': '2017-01-13', 'studyFirstSubmitQcDate': '2017-01-16', 'lastUpdatePostDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dietary induced thermogenis (%)', 'timeFrame': '14 days', 'description': 'Decrease of dietary induced thermogenis after salt vs. placebo'}], 'secondaryOutcomes': [{'measure': 'Systolic blood pressure (mmHg)', 'timeFrame': '14 days', 'description': 'Increase of systolic blood pressure after salt vs. placebo'}, {'measure': 'Lymphocytic pro-inflammatory mediators', 'timeFrame': '14 days', 'description': 'Increase of lymphocytic pro-inflammatory mediators after salt vs. placebo'}, {'measure': 'Gut microbiome', 'timeFrame': '14 days', 'description': 'Change of gut microbiome composition after salt vs. placebo'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Calorimetry', 'Blood pressure', 'Immunophenotyping', 'Gut microbial composition'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '35057434', 'type': 'RESULT', 'citation': 'Mahler A, Klamer S, Maifeld A, Bartolomaeus H, Marko L, Chen CY, Forslund SK, Boschmann M, Muller DN, Wilck N. Increased Salt Intake Decreases Diet-Induced Thermogenesis in Healthy Volunteers: A Randomized Placebo-Controlled Study. Nutrients. 2022 Jan 7;14(2):253. doi: 10.3390/nu14020253.'}]}, 'descriptionModule': {'briefSummary': 'To perform a randomized, double-blind clinical study on the effects of an increased salt intake on metabolic, cardiovascular and immunological parameters and the gut microbiota'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women\n* 18 - 50 years\n* Body mass index 18.5 - 29.9 kg/m2\n\nExclusion Criteria:\n\n* Clinically relevant heart, lung, liver, and kidney diseases\n* Current or chronic infection\n* Habitual use of probiotics or dietary supplements\n* Pregnancy, lactation'}, 'identificationModule': {'nctId': 'NCT03024567', 'acronym': 'TS4', 'briefTitle': 'Randomized Study on Salt Intake and Energy Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Effects of Increased Salt Intake on Energy Metabolism in Healthy Volunteers - a Randomized Clinical Study', 'orgStudyIdInfo': {'id': 'Tissue Salt 4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Salt', 'description': '6 grams sodium chloride per day for 14 days', 'interventionNames': ['Dietary Supplement: Salt']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '6 grams gelatine per day for 14 days', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Salt', 'type': 'DIETARY_SUPPLEMENT', 'description': '10 capsules daily for 14 days', 'armGroupLabels': ['Salt']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '10 capsules daily for 14 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13125', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Experimental and Clinical Research Center', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Anja Maehler', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}