[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Stephen Freedland\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":16,"targetDuration":4,"studyType":19,"phases":20,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100503194","phase-2-intermittent-fasting-using-a-fasting-mimicking-diet-to-improve-prostate-cancer-control-and-metabolic-outcomes-100503194",false,"NCT05832086","Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes","Inclusion Criteria:\n\n* Metastatic castrate sensitive prostate adenocarcinoma (Adenocarcinoma prostate histologically confirmed by biopsy AND Metastatic disease confirmed biopsy, or MRI scan)\n* Men receiving or planning to start first-line intensified ADT (within 30 days of registration) with abiraterone, apalutamide, enzalutamide, or darolutamide with or without current or prior chemotherapy\n* Reads, writes, and understands English or Spanish and has telephone access for remote contact with the study dietitian.\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Allergies to any ingredients listed on the Xentigen Ingredient List\n* Men with diabetes who are not on stable doses of antihyperglycemic medication for at least 6 months and without physician consent that they may safely hold antihyperglycemic medication during the 5 days of FMD\n* Regularly practicing a fasting diet that in the opinion of the study physician would impact study participation\n* Significant co-morbidities (i.e., cardiac, pulmonary, liver disease, ongoing alcohol\u002Fdrug abuse) that in the opinion of the study physician would preclude enrollment in this study.\n* Body Mass Index (BMI) \\\u003C20kg\u002Fm2\n* Men actively trying to lose weight OR on weight loss medications (including but not limited to Contrave, Saxenda, Xenical) or planning to receive weight loss surgery in the next six months\n* Self-reported weight loss ≥ 10% in the last 6 months","MALE",{"count":17,"type":18},138,"ESTIMATED","INTERVENTIONAL",[21],"PHASE2","This is a Phase 2, randomized two-armed, multi-site study of 138 patients with metastatic castrate sensitive prostate adenocarcinoma. Patients will be randomized 1:1 to receive the fasting mimicking diet, or usual diet. All patients will receive standard of care treatment for their prostate cancer. The fasting mimicking diet will be consumed for 5 days per month for a total of 6 months and will be monitored by trained research dietitians.\n\nThis study aims to examine the effects of a fasting mimicking diet (5 days per month eating L-Nutra products only for 6 months) vs. usual diet on response to cancer treatment of metastatic castrate sensitive prostate adenocarcinoma.",[24],"Prostate Adenocarcinoma",[26],"Fasting","RECRUITING","2026-05-02",{"date":30,"type":31},"2026-05-06","ACTUAL",{"date":33,"type":31},"2023-09-13",{"date":35,"type":18},"2029-03-30",{"name":37,"class":38},"Stephen Freedland","OTHER",3,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":15,"minAge":46,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":19,"phases":49,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100349042","phase-2-walnuts-for-power-polyphenols-omega-3-fatty-acids-weight-loss-and-energy-100349042","NCT03824652","WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy","Inclusion Criteria:\n\n* Pathologically confirmed prostate adenocarcinoma.\n* Diagnostic biopsy cores with ≥10 cores with each core examined separately to determine exact tumor location.\n* Biopsy grade group 2 or higher (Gleason ≥7).\n* Planning to undergo RP.\n* Willing to adhere to a usual diet with the possible addition of 2 oz of walnuts per day.\n* Reads, writes, and understands English.\n* Age 18 or older\n\nExclusion Criteria:\n\n* Allergy to nuts.\n* History of receiving hormone therapy or antiandrogen therapy.\n* Use of 5-alpha reductase inhibitors in the past 6 months.\n* Prior prostate radiotherapy (external beam or brachytherapy) or prior prostate cryotherapy.\n* Currently enrolled in a modified diet\u002Fweight loss program and\u002For taking dietary supplements that contain omega-3s (e.g., fish oil).\n* Other active malignancy, excluding basal cell carcinoma or squamous cell carcinoma\n* Significant co-morbidities (e.g., cardiac, pulmonary, liver disease, alcohol\u002Fdrug addiction, malabsorption syndromes), that in the opinion of the study physician make the patient ineligible.\n* Individuals with psychological\u002Fmental conditions which can affect the consent process and\u002For their adherence to the protocol.","18 Years",{"count":48,"type":18},50,[21],"This is a randomized control trial testing the effect of walnut supplementation on prostate cancer progression in 50 men with biopsy confirmed prostate cancer and planning to undergo RP. Patients consented to the study will be randomly assigned to either continue their usual diets (control arm) or to the walnut arm for 4-10 weeks depending on the window between their consent date and the date for RP.",[52],"Prostate Cancer",[54,55,56,57,58,59,60],"prostate cancer","prostate adenocarcinoma","diet","walnuts","radical prostatectomy","omega-3 fatty acids","polyphenols",{"date":62,"type":31},"2026-05-07",{"date":64,"type":31},"2019-04-22",{"date":66,"type":18},"2027-06",{"name":37,"class":38},1,""]