Nctid:
NCT06614374
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-02"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000060825", "term"=>"Cognitive Dysfunction"}], "ancestors"=>[{"id"=>"D000003072", "term"=>"Cognition Disorders"}, {"id"=>"D000019965", "term"=>"Neurocognitive Disorders"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M7115", "name"=>"Diabetes Mellitus", "relevance"=>"LOW"}, {"id"=>"M29705", "name"=>"Cognitive Dysfunction", "asFound"=>"Cognitive Decline", "relevance"=>"HIGH"}, {"id"=>"M6301", "name"=>"Cognition Disorders", "relevance"=>"LOW"}, {"id"=>"M21836", "name"=>"Neurocognitive Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"T415", "name"=>"Omega 3 Fatty Acid", "relevance"=>"LOW"}, {"id"=>"T242", "name"=>"Olive", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Herbal and Botanical", "abbrev"=>"HB"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"TRIPLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>415}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2020-10-10", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2022-02-28", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2022-01-02", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Bone mineral density", "timeFrame"=>"Baseline and 1 year", "description"=>"The Dual-emission X-ray Absorptiometry (DXA) will be assessed to measure the bone mineral density at baseline and post-intervention."}, {"measure"=>"Sleep quality", "timeFrame"=>"Baseline and 1 year", "description"=>"The Pittsburgh Sleep Quality Index (PSQI) will be calculated through questionnaires to evaluate sleep quality. The Changes in sleep quality will be quantified by the difference in PSQI scores between the baseline and the conclusion of the intervention period."}, {"measure"=>"Cognitive function", "timeFrame"=>"Baseline and 1 year", "description"=>"The Mini-Mental State Exams (MMSE) will be conducted to evaluate the cognitive function of participants at both the start and end of the study. Changes in cognitive function will be quantified by the difference in MMSE scores between the baseline and the conclusion of the intervention period."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Fish oil", "Omega-3 fatty acids", "cognitive function", "sleep quality", "bone density"], "conditions"=>["Cognitive Decline", "Sleep", "Bone Mineral Density"]}, "descriptionModule"=>{"briefSummary"=>"The Precision Nutritional Management for Diabetes trial (PNMD; NCT03708887) is a randomized clinical trial in 415 diabetic patients investigating whether taking daily dietary supplements of omega-3 fatty acids (1.5 or 3 grams) improves glucose and lipid homeostasis in Chinese diabetic patients. This ancillary study is being conducted among PNMD participants and will examine whether fish oil supplements affect A) cognitive function, B) sleep quality, and C) bone mineral density. Cognitive function, sleep quality, and bone mineral density will be evaluated at baseline and post-intervention. The Mini-Mental State Exams (MMSE) will be conducted to evaluate the cognitive function of participants. The Pittsburgh Sleep Quality Index (PSQI) will be calculated through questionnaires to evaluate sleep quality. The Dual-emission X-ray Absorptiometry (DXA) will be assessed to measure the bone density."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"40 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1) diagnosed type 2 diabetes according to WHO diagnostic criteria or those on the use of diabetic medications; 2) between 40 and 75 years old (postmenopausal women); 3) have never used n-3 PUFA supplements before or have stopped using them for more than six months.\n\nExclusion Criteria:\n\n1) type 1 diabetes; 2) coronary heart disease, stroke, cancer, hepatic or kidney disease; 3) pregnancy or lactation; 4) allergy to fish; 5) have participated in other clinical trials in the last three months."}, "identificationModule"=>{"nctId"=>"NCT06614374", "briefTitle"=>"Fish Oil for Cognitive Function, Sleep Quality, and Bone Density", "organization"=>{"class"=>"OTHER", "fullName"=>"Zhejiang University"}, "officialTitle"=>"Effects of N-3 Fatty Acids on Cognitive Function, Sleep Quality, and Bone Mineral Density in Diabetic Patients: an Ancillary Study of the Precision Nutritional Management for Diabetes (PNMD) Trial", "orgStudyIdInfo"=>{"id"=>"RCT_N3_SUPPLE"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"PLACEBO_COMPARATOR", "label"=>"Control group", "description"=>"Subjects will receive equivalent amounts of refined olive oil daily.", "interventionNames"=>["Dietary Supplement: Refined olive oil"]}, {"type"=>"EXPERIMENTAL", "label"=>"Low-dose fish oil group", "description"=>"Subjects will receive four fish oil and refined olive oil mixed capsules containing 1.5 g of marine n-3 PUFAs (72% EPA and 28% DHA) per day", "interventionNames"=>["Dietary Supplement: Low-dose fish oil capsules"]}, {"type"=>"EXPERIMENTAL", "label"=>"High-dose fish oil group", "description"=>"Subjects will receive four fish oil capsules containing 3 g of marine n-3 PUFAs (72% EPA and 28% DHA) per day", "interventionNames"=>["Dietary Supplement: High-dose fish oil capsules"]}], "interventions"=>[{"name"=>"Low-dose fish oil capsules", "type"=>"DIETARY_SUPPLEMENT", "description"=>"Patients in the low-dose group will receive four fish-oil and refined olive oil mixed capsules containing 1.5 g of marine n-3 PUFAs per day.", "armGroupLabels"=>["Low-dose fish oil group"]}, {"name"=>"High-dose fish oil capsules", "type"=>"DIETARY_SUPPLEMENT", "description"=>"Patients in the high-dose group will receive four fish oil capsules containing 3 g of marine n-3 PUFAs (72% EPA and 28% DHA) per day.", "armGroupLabels"=>["High-dose fish oil group"]}, {"name"=>"Refined olive oil", "type"=>"DIETARY_SUPPLEMENT", "description"=>"Participants in the control group will receive 4 g refined olive oil daily", "armGroupLabels"=>["Control group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"321102", "city"=>"Jinhua", "state"=>"Zhejiang", "country"=>"China", "facility"=>"Lanxi Red Cross Hospital", "geoPoint"=>{"lat"=>29.10678, "lon"=>119.64421}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Jingjing Jiao", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"Professor", "investigatorFullName"=>"Jingjing Jiao", "investigatorAffiliation"=>"Zhejiang University"}}}}
