Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 10:00 PM
Study NCT ID:
NCT03559361
Status:
COMPLETED
Last Update Posted:
2018-06-18
First Post:
2018-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Sleep Efficiency in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-05', 'studyFirstSubmitDate': '2018-05-22', 'studyFirstSubmitQcDate': '2018-06-05', 'lastUpdatePostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective sleep efficiency', 'timeFrame': '26 weeks', 'description': 'Sleep efficiency scores collected from research sleep watches'}], 'secondaryOutcomes': [{'measure': 'Urinary melatonin', 'timeFrame': '26 weeks', 'description': 'analysis of urine samples for objective measures of Melatonin'}, {'measure': 'Subjective Ratings of Sleep quality', 'timeFrame': '26 weeks', 'description': 'Subjective sleep ratings collected from the leeds sleep evaluation questionnaire'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effects of EPA- and DHA-enriched omega-3 polyunsaturated fatty acid dietary supplements on a number of objective sleep measures (collected from Activity watches) and subjective sleep measures (collected from the Leeds Sleep Evaluation Questionnaire) before and after 26 weeks of supplementation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 25 to 49 years inclusive\n* Males and females\n* Self-report of good health\n* Sleeping pattern must include at least four consecutive nights per week that are the same\n\nExclusion Criteria\n\n* English is not first language (some of the cognitive tasks have only been validated in native English speakers)\n* Habitual consumption of oily fish exceeds one fish meal per week\n* Habitual consumption of n-3 dietary supplements in the previous 6 months\n* Habitual use of dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total; some supplements that do not impact upon cognitive function e.g. garlic, protein, calcium are allowed. Please check with the research team if you are unsure)\n* Are a smoker or consume any nicotine replacement products (e.g. chewing gum, e-cigarettes)?\n* Food allergies or sensitivities to any of the ingredients contained in the investigational product or any other foodstuff\n* Pregnant, trying to get pregnant or breast feeding\n* Body Mass Index outside of the range 18-35 kg/m2\n* High blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)\n* Currently taking blood pressure medication\n* Currently taking blood thinning medication (e.g. aspirin, warfarin, heparin)\n* Have a respiratory disorder that requires regular medication (Note: participants with asthma who only take their medication occasionally/as required are eligible for this study)\n* Have frequent migraines that require medication (more than or equal to 1 per month)\n* History or current diagnosis of drug/alcohol abuse\n* History of kidney or liver disease, or other severe diseases of the gastrointestinal tract (e.g. iron accumulation, iron utilization disorders, hypercalcaemia, hypercalcaemia), that are likely to interfere with metabolism/absorption/secretion of the product under investigation\n* History of neurological or psychiatric illness (excluding depressive illness and anxiety)\n* History of head trauma\n* Sleep disturbances and/or are taking sleep aid medication\n* Blood disorders (e.g. anaemia, haemophilia, thrombocytosis)\n* Diagnosis of type I or type II diabetes\n* Heart disorder, or vascular illness\n* Current diagnosis of depression and/or anxiety\n* Over- or under-active thyroid\n* Chronic gastrointestinal problems (e.g. Inflammatory Bowel Disease, Irritable Bowel Syndrome, celiac disease)\n* Any known active infections\n* Diagnosed with or may be at risk of having syphilis, hepatitis, the Human T - lymphotropic virus or the Human Immunodeficiency Virus\n* Current or past breast cancer diagnosis and/or a mastectomy\n* Health condition that would prevent fulfilment of the study requirements\n* Currently participating in or in the past 4 weeks participated in other clinical or nutrition intervention studies'}, 'identificationModule': {'nctId': 'NCT03559361', 'briefTitle': "26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Sleep Efficiency in Healthy Adults", 'organization': {'class': 'OTHER', 'fullName': 'Northumbria University'}, 'officialTitle': "Efficacy Evaluation of 26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Sleep Efficiency in Healthy Adults", 'orgStudyIdInfo': {'id': '44N5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Olive oil Placebo', 'description': '3 x 1 g capsules daily Placebo: olive oil', 'interventionNames': ['Dietary Supplement: Olive oil Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EPA-rich', 'description': '3 x 1 g capsules daily containing a SMEDDS formulation of an EPA-enriched oil totalling 900 mg EPA and 360 mg of DHA', 'interventionNames': ['Dietary Supplement: EPA-rich']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DHA-Rich', 'description': '3 x 1 g capsules daily containing a SMEDDS formulation of an DHA-enriched oil totalling 900 mg DHA and 270 mg of EPA', 'interventionNames': ['Dietary Supplement: DHA-rich']}], 'interventions': [{'name': 'EPA-rich', 'type': 'DIETARY_SUPPLEMENT', 'description': '6 months omega 3 supplementation', 'armGroupLabels': ['EPA-rich']}, {'name': 'DHA-rich', 'type': 'DIETARY_SUPPLEMENT', 'description': '6 months omega 3 supplementation', 'armGroupLabels': ['DHA-Rich']}, {'name': 'Olive oil Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '6 months placebo supplementation', 'armGroupLabels': ['Olive oil Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NE1 8ST', 'city': 'Newcastle upon Tyne', 'state': 'Tyne and Wear', 'country': 'United Kingdom', 'facility': 'Northumbria University', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northumbria University', 'class': 'OTHER'}, 'collaborators': [{'name': 'BASF', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prinicipal Investigator', 'investigatorFullName': 'Philippa Jackson', 'investigatorAffiliation': 'Northumbria University'}}}}