[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diet-mediterranean\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diet-mediterranean":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100530590","healthy-lifestyles-for-bipolar-disorder-100530590",false,"NCT06188754","Healthy Lifestyles for Bipolar Disorder","Time-restricted Eating vs. Mediterranean Diet as Adjunctive Interventions for Bipolar Disorder","HL","Inclusion Criteria:\n\n* meets diagnostic criteria for bipolar I disorder or bipolar II disorder (but not cyclothymia, BD Not otherwise specified or BD due to another medical condition)\n* current sleep (insomnia, hypersomnolence) or circadian sleep-wake (delayed phase, advanced phase, irregular sleep-wake, non-24-hour sleep-wake-type) concerns indicated by endorsement of at least some sleep or circadian-related impairment across the screening self-reports or interview\n\n  * Living in an English-speaking country (and one that we have expertise in research procedures and diet)\n  * Has been speaking English for at least 10 years, speaks English in the home, or certifies that they are able to understand English well for the study and demonstrates this during the screening interview.\n  * Receiving medical care for BD (referrals will be provided for those who would like to begin care)\n  * Mood-stabilizing medication regimens stable for at least one month\n  * \\\u003C 5 kg weight change in the past 3 months\n  * Currently eating ≥ 12 hours per day at least twice per week\n  * Able to operate the camera function and respond to web-based surveys by phone (loaner phones will be provided as needed)\n  * Not engaged in current shift work or have other responsibilities such as providing care that would chronically disrupt their sleep (i.e., \\> 3 h between 22:00 and 05:00 h for at least 1 day\u002Fweek)\n  * Able to complete 7 days of dietary logs adequately (e.g., at least 2 entries per day, covering at least a 5-hour eating window) during the baseline period\n  * Able to complete screening and baseline questionnaires adequately (e.g., not failing more than 1 attention check item with instructed responding; responding to standard multiple-choice items in a mean of \\\u003C 2 seconds per item). Where individuals respond to more than 14 items in a row with the same response, we will manually review for possible invalidity.\n\nExclusion criteria include the following:\n\n* Current episode of depression, hypomania or mania, or psychosis (assessed by the aDiagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and Related Neuropsychiatric Disorders; DIAMOND), Participants with acute mood disorder episodes will be encouraged to seek treatment and to consider the study when symptoms have remitted.\n* Eating disorder diagnosis (by self-report of treatment or diagnosis at any point during their life, Short Eating Disorder Examination Questionnaire (EDE-QS) scores above clinical concern thresholds for eating disorders, or DIAMOND interview of symptoms during adulthood)\n* Past 3-month alcohol use disorder or substance use disorder (assessed by DIAMOND)\n* Active suicidal ideation coupled with plan, intent or attempt history as assessed by Columbia Suicide Severity Rating Scale\n* Conditions that would interfere with ability to take part in the intervention , including pregnancy, breastfeeding, uncorrected hypo or hyperthyroidism, gastrointestinal conditions impairing nutrient absorption,\n* Medical conditions such as HIV, AIDS, lupus, or multiple sclerosis that could confound the assessment of mania or other measures\n* Medications contraindicated for fasting: clozapine, glucose-lowering medications, diabetes-related injections, medications requiring food early morning or late evening, corticosteroids; medications such as semaglutide will not be an exclusion criteria\n* Cognitive deficits as noted during the initial interview or as indicated by low performance on the Short Orientation Memory Concentration Test (\\\u003C 20 on the weighted score).","ALL","18 Years","65 Years",{"count":21,"type":22},300,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to compare the effects of two different healthy lifestyles on outcomes for those with bipolar disorder. The goals are to understand the acceptability of time-restricted eating and the mediterranean diet for those who are already receiving medication treatment for bipolar disorder, and to consider how these two food plans predict changes in manic symptoms, depressive symptoms, and Quality of Life. Participants will complete daily measures of eating, sleep and mood for two weeks, and then will be assigned to follow one of the two food plans for eight weeks. The investigators will measure symptoms and Quality of Life at baseline and during and after the food plan.",[28,29],"Time Restricted Eating","Diet, Mediterranean",[31,32,33],"bipolar disorder","sleep","circadian rhythm","RECRUITING","2025-02-03",{"date":37,"type":38},"2025-02-06","ACTUAL",{"date":40,"type":38},"2024-06-05",{"date":42,"type":22},"2029-02-28",{"name":44,"class":45},"University of California, Berkeley","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100563303","intervention-based-on-the-mediterranean-diet-during-pregnancy-and-the-first-two-years-for-the-improvement-of-neurological-development-100563303","NCT06614413","Intervention Based on the Mediterranean Diet During Pregnancy and the First Two Years for the Improvement of Neurological Development","Randomized Controlled Clinical Trial: Dietetic-nutritional Intervention Based on the Mediterranean Diet During Pregnancy and the First Two Years, First Thousand Days, for the Improvement of Neurological Development","CONMED","1. Inclusion Criteria:\n\n   a. Fluency in the Spanish language, singleton pregnancy\n2. Exclusion Criteria:\n\n   1. Children conceived with assisted reproduction techniques\n   2. Fetal anomalies and congenital infections\n   3. Neonatal anomalies diagnosed after birth\n   4. Intellectual development disorder, due to clinical judgment, inability to attend visits\n   5. Participation in another controlled trial\n   6. Vegetarian diet",true,{"count":57,"type":22},534,[25],"The main objective is to evaluate the effect of the Mediterranean diet during pregnancy and the first two years of the child\\'s life on the child\\'s neurodevelopment and behavior (externalizing and internalizing disorders) measured at one and a half and two years. Secondary objectives are to evaluate the effect of the Mediterranean diet on: body composition at two years of age in infants (densitometry) and of the mother at 3 months postpartum, the incidence of allergic disease in infants, the fetal and infant ́s growth and metabolic risk in the mother during pregnancy and in the boy\u002Fgirl at two years (fasting glucose: insulin, HOMA), LDL and HDL cholesterol, and micronutrient status (iron, calcium, phosphorus, magnesium, sodium, potassium, chloride, selenium, zinc and LCPUFAs).\n\nRandomized controlled clinical trial with a 1:1 ratio, parallel and open label. Group 1: Mother-child binomial with nutritional intervention; Group 2: Mother-child binomial as a control group (with follow-up without intervention).\n\nAssuming a loss of 25% (10% at follow-up, 15% failure of nutritional intervention) we would need a sample size of 267 patients per group. 1. Evaluation of neurodevelopment using the Bayleys scale version -III, at 2 years of age. 2.\n\nBehavioral assessment CBCL at 1.5 and two years and BRIEF-P at two years.",[29,61,62,63],"Pregnancy Related","Child Development","Infant Behaviour","NOT_YET_RECRUITING","2024-09-25",{"date":67,"type":38},"2024-09-26",{"date":69,"type":22},"2024-10-01",{"date":71,"type":22},"2029-02",{"name":73,"class":45},"Hospital Universitario La Paz"]