Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT07200167
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-06
First Post:
2025-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Efficacy of Dietary Supplementation in Targeting Sleep Quality (NutriSom-01B)
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 70 subjects who will test three formulations (placebo product without active ingredient, active control with melatonin, and test product with valerian root extract). Subjects will have 3 week intervention with each of the tested formulations with 2 week wash-out.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2025-09-22', 'studyFirstSubmitQcDate': '2025-09-22', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Difference in sleep onset latency (SOL) compared to placebo', 'timeFrame': '3 weeks', 'description': 'Difference in sleep onset latency (SOL) compared to placebo assessed by actigraphy.'}, {'measure': 'Difference in sleep efficiency (SE) compared to placebo', 'timeFrame': '3 weeks', 'description': 'Difference in sleep efficiency (SE) compared to placebo - assessed by actigraphy'}], 'primaryOutcomes': [{'measure': 'Difference in sleep onset latency (SOL) compared to placebo', 'timeFrame': '2 weeks', 'description': 'Difference in sleep onset latency (SOL) compared to placebo assessed by actigraphy.'}, {'measure': 'Difference in sleep quality compared to placebo', 'timeFrame': '2 weeks', 'description': 'Difference in sleep quality compared to placebo - assessed by adapted Pittsburgh Sleep Quality Index (PSQI; ranking from 0 \\[best\\] to 21 \\[worst\\])'}], 'secondaryOutcomes': [{'measure': 'Difference in sleep efficiency (SE) compared to placebo', 'timeFrame': '2 weeks', 'description': 'Difference in 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', 'valerian'], '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 70 subjects who will test the efficacy of three formulations 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 \\> 5\n* no clinically significant (subthreshold) insomnia according to Pittsburgh Sleep Quality Index (PSQI-SI) (Kmetec et al., 2022): PSQI \\<= 9\n* a body mass index (BMI) \\<= 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 pharmacological treatment)\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 or work shifts with night work\n* mental incapacity that precludes adequate understanding or cooperation\n* participation in another investigational study'}, 'identificationModule': {'nctId': 'NCT07200167', 'acronym': 'NutriSom-01B', 'briefTitle': 'Study of the Efficacy of Dietary Supplementation in Targeting Sleep Quality (NutriSom-01B)', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Nutrition, Slovenia (Nutris)'}, 'officialTitle': 'Study of the Efficacy of Dietary Supplementation in Targeting Sleep Quality (NutriSom Study B)', 'orgStudyIdInfo': {'id': 'KEP-4-6/2024-B'}, 'secondaryIdInfos': [{'id': 'L7-50044', 'type': 'OTHER_GRANT', 'domain': 'Slovenian Research and Innovation Agency'}, {'id': 'EFSA-2025-00036635', 'type': 'REGISTRY', 'domain': 'EFSA Study Identification'}]}, '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: 21 days of intervention with Placebo Product (PP)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active control (AC)', 'description': 'Active ingredient: 0.3 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: 21 days of intervention with Active Control (AC)']}, {'type': 'EXPERIMENTAL', 'label': 'Test product (TP)', 'description': 'Active ingredient: 480 mg of standardised dry hydroalcoholic extract Valeriana officinalis L., radix (Valerian root) \\[Ph. Eur. 1898\\] Instructions for use: Supplement should be consumed once per day during the intervention period, about one hour to bedtime.', 'interventionNames': ['Dietary Supplement: 21 days of intervention with Test Product (TP)']}], 'interventions': [{'name': '21 days of intervention with Placebo Product (PP)', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 capsule (placebo)', 'armGroupLabels': ['Placebo product (PP)']}, {'name': '21 days of intervention with Active Control (AC)', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 capsule (melatonin)', 'armGroupLabels': ['Active control (AC)']}, {'name': '21 days of intervention with Test Product (TP)', 'type': 'DIETARY_SUPPLEMENT', 'description': '1 capsule (valerian root extract)', 'armGroupLabels': ['Test product (TP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', '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': 'Institute of Nutrition, Slovenia (Nutris)'}, {'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)'}}}}