Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
Study NCT ID:
NCT05837832
Status:
UNKNOWN
Last Update Posted:
2023-05-10
First Post:
2023-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phospholipids as Nutritional Support for Reduction of Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open-label'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2023-04-20', 'studyFirstSubmitQcDate': '2023-04-20', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Leeds Sleep Evaluation', 'timeFrame': '1 week, 2 weeks, 3 weeks, 4 weeks', 'description': 'Changes from baseline in sleep quality'}], 'primaryOutcomes': [{'measure': 'General Anxiety Disorder-7 (GAD-7) Questionnaire', 'timeFrame': '1 week, 2 weeks, 3 weeks, 4 weeks', 'description': 'Change from baseline in anxiety score using the General Anxiety Disorder 7-item. The General Anxiety Disorder-7 scale evaluates anxiety severity using scores ranging from 0-21, higher scores indicate higher anxiety severity, a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Overall Anxiety Severity and Impairment Scale (OASIS) Questionnaire', 'timeFrame': '1 week, 2 weeks, 3 weeks, 4 weeks', 'description': 'Change from baseline in Overall Anxiety Severity and Impairment Scale (OASIS) score. The Overall Anxiety Severity and Impairment scale evaluates anxiety and fear in participants with a score between 0 and 25, higher scores indicate higher anxiety severity, a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn about the effects of a milk-based dietary supplement in adults that report regular and frequent episodes of intermittent anxiety. The main question it aims to answer is: Can this extract be used to reduced symptoms of intermittent anxiety?\n\nParticipants will consume the milk-based dietary supplement every morning for 4 weeks and each week they will fill out 3 different questionnaires.', 'detailedDescription': 'Clinical study evaluating the effects of a dietary milk-based supplement to help reduce symptoms of anxiety. The milk-based supplement is a fat-rich fraction of whey, rich in phospholipids.\n\n24 subjects who report frequent and regular episodes of intermittent anxiety will participate in a questionnaire based clinical trial, wherein they will be consuming the milk-based dietary supplement each morning for 4 weeks.\n\nEach week subjects will fill out 2 questionnaires evaluating their anxiety and 1 questionnaire evaluating their sleep. Changes in stress will be measured relative to baseline scores, collected during the first week before supplement consumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult people of any gender\n* Age 18-75 years (inclusive)\n* BMI between 18.0 and 34.0 (inclusive)\n* Experiencing intermittent episodes of anxiety on a regular basis, leading to either avoiding specific situations, or experiencing stress both in anticipation of, and during such situations.\n* Specific situations that occur regularly that cause anxiety, for example:\n* Performing specific tasks at work or at home\n* Inter-personal conflicts at work or at home\n* Driving or commuting\n* Fearful and worrying about one's own situation (such as paying bills)\n* Worrying about ongoing problems experienced by others\n\nExclusion Criteria:\n\n* Cancer during the past 12 months\n* Chemotherapy during the past 12 months\n* Currently taking anxiolytic, hypnotic, or anti-depressant prescription medication\n* Currently taking nutritional supplements judged by the study coordinator to negate or camouflage the effects of the test product\n* Food allergies or insensitivity related to lactose or other ingredients in test product\n* People who are pregnant, nursing, or trying to become pregnant"}, 'identificationModule': {'nctId': 'NCT05837832', 'briefTitle': 'Phospholipids as Nutritional Support for Reduction of Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Natural Immune Systems Inc'}, 'officialTitle': 'Phospholipids as Nutritional Support for Reduction of Anxiety', 'orgStudyIdInfo': {'id': '192-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Participants will consume the dietary supplement every morning for 4 weeks.', 'interventionNames': ['Dietary Supplement: Milk-based phospholipids']}], 'interventions': [{'name': 'Milk-based phospholipids', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Powder based, fat-rich fraction of whey dissolved in water. Contains lactose.', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Gitte S Jensen, PhD', 'role': 'CONTACT', 'email': 'Gitte@nislabs.com', 'phone': '541 882 0112'}, {'name': 'Alex Cruickshank', 'role': 'CONTACT', 'email': 'Alex@nislabs.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Natural Immune Systems Inc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}