Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-30 @ 11:50 PM
Study NCT ID:
NCT06600633
Status:
RECRUITING
Last Update Posted:
2024-09-20
First Post:
2024-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Dietary Supplementation With Melatonin in Targeting Sleep Quality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Three-period crossover study will include 30 subjects who will test three formulations with diferent melatonin dosages (placebo product without melatonin, and two products with different melatonin levels). Subjects will have 2 week intervention with each of the tested formulations with 2 week wash-out.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-18', 'studyFirstSubmitDate': '2024-09-12', 'studyFirstSubmitQcDate': '2024-09-16', 'lastUpdatePostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in sleep onset latency (SOL) compared to placebo', 'timeFrame': 'last 7 days of intervention', 'description': 'Change in sleep onset latency (SOL) compared to placebo assessed by actigraphy.'}], 'secondaryOutcomes': [{'measure': 'Changed sleep quality compared to placebo', 'timeFrame': '14 days', 'description': 'Changed sleep quality compared to placebo - assessed by adapted Pittsburgh Sleep Quality Index (PSQI)'}, {'measure': 'Changed sleep efficiency (SE) compared to placebo', 'timeFrame': 'last 7 days of intervention', 'description': 'Changed sleep efficiency (SE) compared to placebo - assessed by actigraphy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['melatonin', 'supplementation', 'sleep', 'sleep onset latency', 'actigraphy', 'sleep quality', 'sleep efficiency'], 'conditions': ['Sleep Onset Latency', 'Sleep Quality']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://nutris.org/en/projects/nutrisom', 'label': 'NutriSom project webpage: Efficacy and safety of dietary supplementation in targeting sleep quality (L7-50044)'}]}, 'descriptionModule': {'briefSummary': 'single-center, randomized, cross over, double-blind, placebo controlled intervention study', 'detailedDescription': 'The single-center, randomized, cross over, double-blind, placebo controlled intervention study will include 30 subjects who will test the efficacy of three formulations with different dosages of melatonin on sleep quality parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '24 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* subject Informed consent form (ICF) is signed\n* aged 24-65 years at the time of the signature of ICF\n* suboptimal sleep quality according to Pittsburgh Sleep Quality Index (PSQI-SI): PSQI higher than 5\n* no clinically significant (subthreshold) insomnia according to Pittsburgh Sleep Quality Index (PSQI-SI) (Kmetec et al., 2022): PSQI up to 9\n* a body mass index (BMI) up to 32 kg/m2\n* stable medications for non excluded concurrent medical conditions for six weeks prior to the screening visit\n* ability to ingest oral food supplement (study product)\n* willing to follow all study procedures, including attending all site visits and use of actigraphy\n\nExclusion criteria:\n\n* diagnosed or subject to therapy due to sleep disorders\n* acute infectious disease\n* any kind of chronic pharmacological therapy with antihypertensives or antidepressants\n* any kind of other pharmacological therapy that could interact with active ingredients used in the study\n* pregnancy or planned pregnancy, lactation, menopause (with clinically relevant symptoms/therapy)\n* use of beta-blockers\n* chronic use of use of prostaglandin synthesis inhibitors (nonsteroidal anti-inflammatory drugs), such as acetylsalicylic acid and ibuprofen\n* supplementation with melatonin or other food supplements intendent for sleep quality during last 2 weeks\n* unwillingness to maintain caffeine abstinence after 4:00 PM during the study\n* not having a mobile upper extremity for attaching an actigraph\n* known alcohol and/or drug abuse\n* unwillingness to comply with the maximum limit of 2 alcoholic drinks per day, and only up to 1 alcoholic drink after 6:00 PM during the study\n* known lactose/gluten intolerances/food allergies\n* known gastrointestinal disease\n* less than 5 years after treatment for gastrointestinal cancer (stomach, duodenum or colon)\n* have stomach or bowel resection\n* night work (including as part of shift work)\n* mental incapacity that precludes adequate understanding or cooperation\n* participation in another investigational study'}, 'identificationModule': {'nctId': 'NCT06600633', 'acronym': 'NutriSom-01A', 'briefTitle': 'Efficacy of Dietary Supplementation With Melatonin in Targeting Sleep Quality', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Nutrition, Slovenia (Nutris)'}, 'officialTitle': 'Study of the Efficacy of Dietary Supplementation in Targeting Sleep Quality (NutriSom Study A)', 'orgStudyIdInfo': {'id': 'KEP-4-6/2024-A'}, 'secondaryIdInfos': [{'id': 'L7-50044', 'type': 'OTHER_GRANT', 'domain': 'Slovenian Research and Innovation Agency'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo product (PP)', 'description': 'Active ingredient: none Instructions for use: Supplement should be consumed once per day during the intervention period, about one hour to bedtime.', 'interventionNames': ['Dietary Supplement: 14 days of intervention with Placebo Product (PP)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active control (AC)', 'description': 'Active ingredient: 1 mg of melatonin per dosage Instructions for use: Supplement should be consumed once per day during the intervention period, about one hour to bedtime.', 'interventionNames': ['Dietary Supplement: 14 days of intervention with Active Control (AC)']}, {'type': 'EXPERIMENTAL', 'label': 'Test product (TP)', 'description': 'Active ingredient: 0.3 mg of melatonin per dossage Instructions for use: Supplement should be consumed once per day during the intervention period, about one hour to bedtime.', 'interventionNames': ['Dietary Supplement: 14 days of intervention with Test Product (TP)']}], 'interventions': [{'name': '14 days of intervention with Placebo Product (PP)', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 spray (0 mg melatonin)', 'armGroupLabels': ['Placebo product (PP)']}, {'name': '14 days of intervention with Active Control (AC)', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 spray (1 mg melatonin)', 'armGroupLabels': ['Active control (AC)']}, {'name': '14 days of intervention with Test Product (TP)', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 spray (0.3 mg melatonin)', 'armGroupLabels': ['Test product (TP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Barbara Gnidovec Stražišar', 'role': 'CONTACT', 'email': 'raziskave@nutris.org', 'phone': '+386 590 68 70'}, {'name': 'Barbara Gnidovec Stražišar', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CMS - Center za motnje spanja', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'centralContacts': [{'name': 'Igor Pravst, PhD', 'role': 'CONTACT', 'email': 'igor.pravst@nutris.org', 'phone': '+386 590 68871'}], 'overallOfficials': [{'name': 'Igor Pravst', 'role': 'STUDY_CHAIR', 'affiliation': 'Nutrition Institute, Ljubljana'}, {'name': 'Barbara Gnidovec Stražišar', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Health Sciences in Celje, CMS - Center za motnje spanja'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Nutrition, Slovenia (Nutris)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Faculty of Pharmacy, University of Ljubljana, Slovenia', 'class': 'UNKNOWN'}, {'name': 'Faculty of health sciences, Celje, Slovenia', 'class': 'UNKNOWN'}, {'name': 'CMS - Center za motnje spanja, Ljubljana, Slovenia', 'class': 'UNKNOWN'}, {'name': 'Valens Int. d.o.o., Slovenija', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Igor Pravst', 'investigatorFullName': 'Igor Pravst', 'investigatorAffiliation': 'Institute of Nutrition, Slovenia (Nutris)'}}}}