Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-01-22 @ 12:33 PM
Study NCT ID:
NCT03467568
Status:
UNKNOWN
Last Update Posted:
2018-03-16
First Post:
2018-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Salt Intake Improve Mood
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Salt / placebo will be consumed by capsule under a double blind procedure'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study has four arms. Salt alone; salt plus water; placebo alone, placebo plus water'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-09', 'studyFirstSubmitDate': '2018-02-16', 'studyFirstSubmitQcDate': '2018-03-09', 'lastUpdatePostDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mood ratings using visual analogue scales', 'timeFrame': 'Up to three hours', 'description': 'On a hundred millimetre scale ratings will be made of with the two ends anchored with the words Agreeable/Hostile, Confused/clearheaded; composed/anxious; depressed/elated; confident/unsure; tired/energetic. Each scales produces a score between 0 and 100. When added to create a total mood score the ratings vary between zero and six hundred with a higher score indicating a better mood'}], 'secondaryOutcomes': [{'measure': 'Ratings of thirst', 'timeFrame': 'Up to three hours', 'description': 'Rating made using a visual analogue scale responding to the question how thirsty do you feel right now? With a high score indicated greater thrist'}, {'measure': 'Body weight', 'timeFrame': 'Up to three hours', 'description': 'Changes in body weight over morning. Scales measuring to the nearest 10g will be used'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mood Salt'], 'conditions': ['Mood', 'Salt Intake']}, 'descriptionModule': {'briefSummary': 'Humans display a preference for salt although the reasons remain unclear. The aim was to examine the hypothesis that salt may enhance mood. The study compares the drinking of water with and without electrolytes (either dissolved in water or by capsule). Mood was rated over a period of 155 minutes', 'detailedDescription': 'Study 1. 120 young adults will be were recruited. They will arrive in the laboratory at 0900 having consumed their normal breakfast. Over the morning they will reported their mood by responding to one hundred millimetre visual analogue scales anchored with the words: Composed/Anxious; Hostile/Agreeable; Elated/Depressed; Unsure/Confident; Energetic/Tired; Confused/Clearheaded. These dimensions of mood came from the factor analysis that formed the basis of the Profile of Mood State questionnaire. An overall measure of mood will be calculated. .\n\nRandomly they will receive either a 150ml glass of water, or an equivalent volume of water containing electrolytes (in total 150mg sodium chloride and 45mg potassium chloride (Gatorade G2 Low calorie (34 kcal) Thirst Quencher, Pepsico). This drink will be consumed for a first time after 50 minutes, and a second time after 140 minutes. A estimate of habitual salt preference will be gained by responding to questions concerning the adding of salt to meals and a preference for salty foods.\n\nStudy 2: One hundred and twenty young adults will be recruited. A second study attempts to replicate the first in a double-blind trial where the taste of salt was hidden by using a capsule. . Participants will be assigned to one of four experimental conditions; 1) swallowed placebo capsules; 2) swallowed capsules containing electrolyte (300mg sodium chloride); 3) received placebo capsules and plain water; 4) received capsules containing electrolyte and plain water. Each drink will be 150ml of water. The allocation of the type of capsule will be carried out double-blind, determined by computer generated random numbers.\n\nOtherwise the procedure will be identical to study one.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Self declared in good health -\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03467568', 'briefTitle': 'Does Salt Intake Improve Mood', 'organization': {'class': 'OTHER', 'fullName': 'Swansea University'}, 'officialTitle': 'Do Humans Over-consume Salt to Improve Mood', 'orgStudyIdInfo': {'id': 'DB-0123-SALT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sodium chloride / Water', 'description': 'The sodium chloride / water arm involves 300mg sodium chloride being consumed in a capsule and on two occasions 150ml of water being drunk', 'interventionNames': ['Dietary Supplement: Sodium Chloride', 'Dietary Supplement: Water']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sodium chloride / no water', 'description': 'A capsule containing 300mg of sodium chloride will be consumed but no water will be drunk over the morning', 'interventionNames': ['Dietary Supplement: Sodium Chloride', 'Biological: No water consumed']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo / water', 'description': 'A capsule containing a placebo will be consumed and on two occasions 150ml of water will be drunk', 'interventionNames': ['Other: Placebo capsule', 'Dietary Supplement: Water']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo / no water', 'description': 'A capsule containing a placebo will be consumed but no water will be drunk over the morning', 'interventionNames': ['Other: Placebo capsule', 'Biological: No water consumed']}], 'interventions': [{'name': 'Sodium Chloride', 'type': 'DIETARY_SUPPLEMENT', 'description': '300mg sodium chloride will be provided in a capsule', 'armGroupLabels': ['Sodium chloride / Water', 'Sodium chloride / no water']}, {'name': 'Placebo capsule', 'type': 'OTHER', 'description': 'A capsule of identical appearance to that providing salt, but not containing electrolytes, will be consumed', 'armGroupLabels': ['Placebo / no water', 'Placebo / water']}, {'name': 'Water', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Twice during the morning a drink of 150ml of water will be consumed', 'armGroupLabels': ['Placebo / water', 'Sodium chloride / Water']}, {'name': 'No water consumed', 'type': 'BIOLOGICAL', 'description': 'No water will be consumed during the monring', 'armGroupLabels': ['Placebo / no water', 'Sodium chloride / no water']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'sa2 8pp', 'city': 'Swansea', 'state': 'Wales', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Hayley Young, PhD', 'role': 'CONTACT', 'email': 'h.a.young@swansea.ac.uk', 'phone': '++44 1792 295607'}, {'name': 'David Benton, DSc', 'role': 'CONTACT', 'email': 'd.benton@swansea.a.cuk', 'phone': '++44 1792 295607'}, {'name': 'David Benton, DSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Psychology, Swansea University', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}], 'centralContacts': [{'name': 'David Benton, DSc', 'role': 'CONTACT', 'email': 'd.benton@swansea.ac.uk', 'phone': '++441792295607'}, {'name': 'Hayley Young, PhD', 'role': 'CONTACT', 'email': 'h.a.young@swansea.a.cuk', 'phone': '++441792295908'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swansea University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'David Benton', 'investigatorAffiliation': 'Swansea University'}}}}