[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535522":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":8,"locations":14,"responsibleParty":33,"collaborators":7,"id":36,"slug":7,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":41,"eligibilityCriteria":42,"healthyVolunteers":43,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":7,"studyType":50,"phases":7,"briefSummary":51,"conditions":52,"keywords":56,"overallStatus":16,"whyStopped":7,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},{"fullName":5,"class":6},"Pennington Biomedical Research Center","OTHER",null,[9],{"name":10,"role":11,"phone":12,"phoneExt":7,"email":13},"Emily Flanagan, PhD","CONTACT","(225) 763-2828","Emily.Flanagan@pbrc.edu",[15],{"facility":5,"status":16,"city":17,"state":18,"zip":19,"country":20,"countryCode":21,"cosmosGeoPoint":22,"geoPoint":27,"contacts":28},"RECRUITING","Baton Rouge","Louisiana","70808","United States","US",{"type":23,"coordinates":24},"Point",[25,26],-91.18747,30.44332,{"lat":26,"lon":25},[29,31],{"name":10,"role":11,"phone":30,"phoneExt":7,"email":13},"225-763-2828",{"name":10,"role":32,"phone":7,"phoneExt":7,"email":7},"PRINCIPAL_INVESTIGATOR",{"type":32,"investigatorFullName":34,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"Emily W. Flanagan, MS, PhD","Postdoctoral Researcher","100535522",false,"NCT06252922","Diet-Induced Changes in GEnetic Material","A Pilot Study to Examine Metabolic Flexibility as a Mechanism for Diet- Induced Epigenetic Alterations in Male Gametes","DIG 'EM","Inclusion Criteria:\n\n* Male based on biological sex\n* Age 20-35 years\n* BMI between 18.5 and 24.9 kg\u002Fm2\n* White\u002FCaucasian\n* Willing to consume pre-prepared meals\n* Willing to wear an accelerometer and continuous glucose monitor (CGM)\n* Willing to track diet intake\n* Willing to stay 24 hours, including overnight in a research clinic\n* Willing to provide blood and sperm samples\n* Willing to consent to whole-genome sequencing of DNA\n\nExclusion Criteria:\n\n* Unstable weight in the last 3 months (±5% weight loss or gain)\n* Shift work or working in a factory setting\n* Habitual smoking or use of tobacco products, including vaping, within the past 6 months.\n* History of clinically diagnosed diabetes\n* Hypertension (\\>140\u002F90 mmHg measured at screening)\n* Has undergone bariatric surgery\n* History of cardiovascular disease, neurological disease, or other chronic diseases, including cancer\n* History of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)\n* Adherence to special or restrained diets (e.g., low-CHO, low-fat, or vegetarian\u002Fvegan diets) or food allergies associated with study foods.\n* Currently engaging in \\>150 minutes moderate-intensity or \\>75 minutes of vigorous-intensity physical activity each week\n* Drinking more than 14 servings of beer or alcohol per week\n* Depressive (Score ≥10), anxiety (Score ≥8), and stress (Score≥15) symptomology (Score ≥16) from the 42-item Depression, Anxiety, Stress Scales (DASS)",true,"MALE","20 Years","35 Years",{"count":48,"type":49},10,"ESTIMATED","OBSERVATIONAL","This is a pilot study in 10 men to test the hypothesis that perturbations in substrate flux and the circulating metabolic and pro-inflammatory milieus during a high-fat diet paradigm will modulate DNA methylation of genes in sperm associated with obesity and cardiometabolic dysfunction.",[53,54,55],"Diet, Healthy","Body Weight","Metabolic Disturbance",[57,58,59,60,61,62,63],"Healthy Weight","High-Fat Diet","Sperm DNA Methylation","Metabolic Flexibility","DNA Damage","Substrate Flux","Preconception","2025-05-27",{"date":66,"type":67},"2025-05-31","ACTUAL",{"date":69,"type":67},"2023-11-11",{"date":71,"type":49},"2026-12-30",{"name":5,"class":6},1]