Ignite Creation Date:
2025-12-24 @ 7:33 PM
Ignite Modification Date:
2026-02-23 @ 9:22 PM
Study NCT ID:
NCT02209103
Status:
COMPLETED
Last Update Posted:
2015-11-20
First Post:
2014-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Sleep Improving Effects of Orange Phenolics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-19', 'studyFirstSubmitDate': '2014-08-04', 'studyFirstSubmitQcDate': '2014-08-04', 'lastUpdatePostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep quality as assessed objectively by means of a portable sleep monitoring system (ZEO)', 'timeFrame': '9 test nights (up to 9 days)', 'description': '• The primary endpoint for this study is the determination of sleep quality, as assessed objectively with the portable sleep monitoring system ZEO, which is based on EEG/EMG (electromyography) coupled with an automatic sleep phase classifier. Sleep stages are classified as deep sleep, light sleep, REM (rapid eye movement) sleep or awake. The sleep patterns of the participants after ingestion of the two different test products will be compared to each other and to placebo.'}], 'secondaryOutcomes': [{'measure': 'Subjective sleep quality ratings and fitness, tiredness and cognitive ratings, obtained from questionnaires', 'timeFrame': 'up to 9 days. Questionnaires are filled out the morning after every test night', 'description': 'Leeds Sleep Evaluation Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Polyphenols', 'Orange', 'Sleep', 'Fatigue'], 'conditions': ['Polyphenols', 'Sleep', 'Fatigue']}, 'descriptionModule': {'briefSummary': 'This study aims to determine whether a citrus flavonoid or a citrus flavonoid formulation can improve objective sleep duration and/or quality, and/or improve perceived sleep quality and feelings of rest.\n\nParticipants will complete a total of 9 test nights, which consist of sleeping with the sleep monitoring system after ingestion of the test product or a placebo, and filling out sleep-related questionnaires.\n\nThe study has a crossover design, meaning that all participants receive all three interventions (citrus flavonoid, citrus flavonoid formulation, placebo) three times, in a randomized order.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-75\n* Non-smoking\n* Healthy\n* Lightly disturbed sleep for at least six months, on a regular basis\n\nExclusion Criteria:\n\n* Severe sleep disorders (sleep apnea, restless legs syndrome)\n* An apparent cause for the sleep disorders (pain, etc.)\n* Clinically significant abnormal liver functioning\n* Clinically significant abnormal serum creatinine\n* BMI lower than 18 or higher than 30 kg/m2\n* Use of concomitant medications or supplements'}, 'identificationModule': {'nctId': 'NCT02209103', 'briefTitle': 'The Sleep Improving Effects of Orange Phenolics', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Determination of the Sleep Improving Effects of Phenolics From an Orange Peel Extract', 'orgStudyIdInfo': {'id': 'NL43845.068.13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Citrus flavonoid', 'description': 'Citrus flavonoid', 'interventionNames': ['Dietary Supplement: Lozenge containing citrus flavonoid']}, {'type': 'EXPERIMENTAL', 'label': 'Citrus flavonoid formulation', 'description': 'Citrus flavonoid formulation', 'interventionNames': ['Dietary Supplement: Lozenge containing citrus flavonoid formulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: Identical looking placebo']}], 'interventions': [{'name': 'Lozenge containing citrus flavonoid', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Citrus flavonoid']}, {'name': 'Lozenge containing citrus flavonoid formulation', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Citrus flavonoid formulation']}, {'name': 'Identical looking placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center (MUMC)', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Chris Van der Grinten', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department: lung diseases MUMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}