Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-29 @ 3:22 PM
Study NCT ID:
NCT06239168
Status:
RECRUITING
Last Update Posted:
2024-02-02
First Post:
2023-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Citrus Extract, Sleep and Mental Wellbeing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000716707', 'term': 'grapefruit seed extract'}, {'id': 'C008315', 'term': 'maltodextrin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-26', 'studyFirstSubmitDate': '2023-12-14', 'studyFirstSubmitQcDate': '2024-01-26', 'lastUpdatePostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in sleep quality scores between the intervention and placebo group', 'timeFrame': '8 weeks of intervention', 'description': 'Measured by a sleep quality questionnaire (PSQI)'}, {'measure': 'Changes in sleep quality between the intervention and placebo group', 'timeFrame': '8 weeks of intervention', 'description': 'Measured using actigraphy'}], 'secondaryOutcomes': [{'measure': 'Changes in mental wellbeing between the intervention and placebo group', 'timeFrame': '8 weeks of intervention', 'description': 'Measured by mental wellbeing questionnaires'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Disturbance']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled, cross-over trial investigating the effects of daily administration of citrus extract on sleep and mental wellbeing.', 'detailedDescription': 'Based on epidemiological data, a substantial number of people report to have sleeping problems. This is of major concern, as poor sleep quality has been associated with impaired mental and physical health. Several pre-clinical studies have shown promising results, but evidence from human studies is still limited. Therefore, the aim of the present study is to investigate the effect of a citrus extract on sleep and mental wellbeing in healthy subjects with (minor) sleep disturbance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy individuals with (minor) sleep disturbance\n* Age 40-70 years\n* BMI 18.5 - 30 kg/m2\n* Willingness to give up being a blood donor from 4 weeks before the start of the study, during the study and for 4 weeks after completion of the study\n\nExclusion Criteria:\n\n* Excessive caffeine use\n* Major psychiatric/mental health disorders .\n* Chronic sleep disorders\n* Severe sleep disturbance for more than 1 year\n* Other clear causes for poor sleep quality or mental wellbeing\n* Use of medication or supplements that can affect outcomes\n* Nonpharmacological treatment for sleep disorders\n* Flight from a time-zone with \\>3 h difference ≤1 week before an intervention period\n* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study\n* Use of pre-, pro- or synbiotics within 1 month prior to the start of the study\n* Reported weight loss or weight gain of \\>3 kg in the month prior to pre-study screening\n* Smoking\n* Abuse of products\n* Known allergy to citruses\n* Known pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT06239168', 'briefTitle': 'Citrus Extract, Sleep and Mental Wellbeing', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'The Effect of Citrus Extract on Sleep and Mental Wellbeing', 'orgStudyIdInfo': {'id': '23-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Citrus extract', 'description': 'Daily Citrus extract supplementation for 8 weeks.', 'interventionNames': ['Dietary Supplement: Citrus extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Daily Maltodextrin supplementation for 8 weeks.', 'interventionNames': ['Dietary Supplement: Maltodextrin']}], 'interventions': [{'name': 'Citrus extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'As described in experimental arm', 'armGroupLabels': ['Citrus extract']}, {'name': 'Maltodextrin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'As described in comparator arm', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Yala Stevens, PhD', 'role': 'CONTACT', 'email': 'yala.stevens@maastrichtuniversity.nl', 'phone': '+31437114555'}, {'name': 'Jogchum Plat, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tanja Adam, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Maastricht University', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'centralContacts': [{'name': 'Yala Stevens, PhD', 'role': 'CONTACT', 'email': 'yala.stevens@maastrichtuniversity.nl', 'phone': '+31437114555'}], 'overallOfficials': [{'name': 'Jogchum Plat', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University'}, {'name': 'Tanja Adam', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'BioActor', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}