[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07590804":3,"trial-entities:NCT07590804":168,"trial-summary:NCT07590804":173},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":19,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":48,"secondary_outcomes":53,"sex":54,"minimum_age":55,"maximum_age":15,"healthy_volunteers":56,"eligibility_criteria":57,"std_ages":82,"locations":85,"central_contacts":158,"overall_officials":161,"references":164,"see_also_links":165},"NCT07590804","26-086","A Dietary Study for People With Clonal Hematopoiesis","A Decentralized High-Fiber Dietary Intervention Trial in Clonal Hematopoiesis - NUTRIVENTION-CH","RECRUITING","2027-05","2026-05","2026-05-15","2026-05-04","Memorial Sloan Kettering Cancer Center","OTHER",null,"The researchers are doing this study to find out whether a high-fiber plant-based diet (HFPBD) can improve quality of life for people with CH. A HFPBD includes foods that are mainly from plants (for example, fruits,vegetables, nuts, beans, and whole grains). The researchers will measure quality of life by having participants complete questionnaires\u002Fsurveys.",[18],"Clonal Hematopoiesis",[20],"High-Fiber Plant Diet","INTERVENTIONAL","PREVENTION",[24],"NA",{"count":26,"type":27},36,"ESTIMATED",[29,34,38,43],{"type":14,"name":30,"description":31,"armGroupLabels":32},"high-fiber plant-based meals","A meal service will ship 12 frozen prepared meals per week to your home.",[33],"High Fiber Plant-Based Diet",{"type":14,"name":35,"description":36,"armGroupLabels":37},"fermented foods","Fermented foods will be encouraged on the diet. Fermented foods contain probiotics that help support a balanced gut microbiome and might improve overall digestion.",[33],{"type":39,"name":40,"description":41,"armGroupLabels":42},"DIETARY_SUPPLEMENT","supplements","Patients will be recommended by research dietitian to take a weekly vitamin B12 supplement (at least 500 mcg weekly)",[33],{"type":14,"name":44,"description":45,"armGroupLabels":46},"surveys","QOL will be measured with the EORTC QLQ C30",[33,47],"Usual care arm",[49],{"measure":50,"description":51,"timeFrame":52},"compare the rates of improvement in Quality Of Life","using the Quality of Life Global Health Status at W13D1 Scoring will be based on standard EORTC criteria","up to 12 weeks",[],"ALL","18 Years",false,{"inclusion":58,"exclusion":68,"raw_text":81},[59,60,61,62,63,64,65,66,67],"Patients must have confirmed clonal hematopoiesis via next generation sequencing (NGS) of blood or bone marrow biopsy sample","Patients with clonal cytopenias of undetermined significance (CCUS) are eligible if a bone marrow biopsy is done to exclude other causes.","Variant allele frequency must be ≥2% for mutation as measured by (NGS)","Treatment at MSK or at sites listed below that uses EPIC for electronic medical records and willing to share records with MSK through EPIC's care everywhere or through MSK's shared care network. If not meeting this criterion, decision to allow for participation is per PI discretion.","Age ≥ 18 years","BMI ≥25 kg\u002Fm\\^2","Participant or caregiver must be able to complete surveys and have interest in trying new recipes or cooking.","Screening 24-hour dietary recall must consume \\\u003C30 grams dietary fiber per day to be eligible (any one of two 24-hour screening dietary recalls).","For patients at MSK, require bone marrow biopsy at screening in the past 24 weeks with collection of research biobanking sample. Bone marrow at other sites is optional.",[69,70,71,72,73,74,75,76,77,78,79,80],"Prior MDS\u002FAML directed therapy","Chemotherapy, radiation, or immunotherapy within the past year (surgical- resection only or other cancer\u002Fprecancer on observation is eligible)","Patients with a concurrent malignancy whose natural history or treatment may compromise completion of this trial are excluded.","Concurrent pregnancy will make a participant ineligible to participate","Patients that already follow a minimally processed (whole food) plant-based diet in the last 3 months are not eligible (ovo-lacto-vegetarian or processed junk food vegan diets are eligible).","Patients on GLP-1 drugs are eligible if it has been started at least 3 months prior to study and on stable dose. If it has been started more recently for diabetes mellitus control but not weight loss they are eligible. If it is medically indicated and started for diabetes mellitus control while on trial they will not be removed\u002Fexcluded from trial.","Mental impairment leading to inability to cooperate will lead to exclusion from trial participation.","If in the opinion of the investigator there maybe any concerns regarding the ability of the patient to complete the study safely or any contraindications.","Concurrent weight loss or dietary programs will be ineligible if require a specific diet or weight loss supplements.","Plan for prolonged travel during the study that would preclude adherence to prescribed diet. Willingness to comply during travel is not an exclusion.","Severe allergy to any legume (such as anaphylactic shock) or allergies to multiple legumes or if cross-contamination is a risk are not eligible.","Severe allergies such as anaphylactic shock to peanuts and\u002For tree nuts, such as cashews are not eligible.","Inclusion Criteria:\n\n* Patients must have confirmed clonal hematopoiesis via next generation sequencing (NGS) of blood or bone marrow biopsy sample\n* Patients with clonal cytopenias of undetermined significance (CCUS) are eligible if a bone marrow biopsy is done to exclude other causes.\n* Variant allele frequency must be ≥2% for mutation as measured by (NGS)\n* Treatment at MSK or at sites listed below that uses EPIC for electronic medical records and willing to share records with MSK through EPIC's care everywhere or through MSK's shared care network. If not meeting this criterion, decision to allow for participation is per PI discretion.\n* Age ≥ 18 years\n* BMI ≥25 kg\u002Fm\\^2\n* Participant or caregiver must be able to complete surveys and have interest in trying new recipes or cooking.\n* Screening 24-hour dietary recall must consume \\\u003C30 grams dietary fiber per day to be eligible (any one of two 24-hour screening dietary recalls).\n* For patients at MSK, require bone marrow biopsy at screening in the past 24 weeks with collection of research biobanking sample. Bone marrow at other sites is optional.\n\nExclusion Criteria:\n\n* Prior MDS\u002FAML directed therapy\n* Chemotherapy, radiation, or immunotherapy within the past year (surgical- resection only or other cancer\u002Fprecancer on observation is eligible)\n* Patients with a concurrent malignancy whose natural history or treatment may compromise completion of this trial are excluded.\n* Concurrent pregnancy will make a participant ineligible to participate\n* Patients that already follow a minimally processed (whole food) plant-based diet in the last 3 months are not eligible (ovo-lacto-vegetarian or processed junk food vegan diets are eligible).\n* Patients on GLP-1 drugs are eligible if it has been started at least 3 months prior to study and on stable dose. If it has been started more recently for diabetes mellitus control but not weight loss they are eligible. If it is medically indicated and started for diabetes mellitus control while on trial they will not be removed\u002Fexcluded from trial.\n* Mental impairment leading to inability to cooperate will lead to exclusion from trial participation.\n* If in the opinion of the investigator there maybe any concerns regarding the ability of the patient to complete the study safely or any contraindications.\n* Concurrent weight loss or dietary programs will be ineligible if require a specific diet or weight loss supplements.\n* Plan for prolonged travel during the study that would preclude adherence to prescribed diet. Willingness to comply during travel is not an exclusion.\n* Severe allergy to any legume (such as anaphylactic shock) or allergies to multiple legumes or if cross-contamination is a risk are not eligible.\n* Severe allergies such as anaphylactic shock to peanuts and\u002For tree nuts, such as cashews are not eligible.",[83,84],"ADULT","OLDER_ADULT",[86,100,109,118,128,137,149],{"facility":87,"status":8,"city":88,"state":89,"zip":90,"country":91,"contacts":92,"geoPoint":97},"Memorial Sloan Kettering Basking Ridge (All Protocol Activities)","Basking Ridge","New Jersey","07920","United States",[93],{"name":94,"role":95,"phone":96},"Urvi Shah, MD","CONTACT","646-608-3713",{"lat":98,"lon":99},40.70621,-74.54932,{"facility":101,"status":8,"city":102,"state":89,"zip":103,"country":91,"contacts":104,"geoPoint":106},"Memorial Sloan Kettering Monmouth (All Protocol Activities)","Middletown","07748",[105],{"name":94,"role":95,"phone":96},{"lat":107,"lon":108},40.39428,-74.11709,{"facility":110,"status":8,"city":111,"state":89,"zip":112,"country":91,"contacts":113,"geoPoint":115},"Memorial Sloan Kettering Bergen (All Protocol Activities)","Montvale","07645",[114],{"name":94,"role":95,"phone":96},{"lat":116,"lon":117},41.04676,-74.02292,{"facility":119,"status":8,"city":120,"state":121,"zip":122,"country":91,"contacts":123,"geoPoint":125},"Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)","Commack","New York","11725",[124],{"name":94,"role":95,"phone":96},{"lat":126,"lon":127},40.84288,-73.29289,{"facility":129,"status":8,"city":130,"state":121,"zip":131,"country":91,"contacts":132,"geoPoint":134},"Memorial Sloan Kettering Westchester (All Protocol Activities)","Harrison","10604",[133],{"name":94,"role":95,"phone":96},{"lat":135,"lon":136},40.96899,-73.71263,{"facility":138,"status":8,"city":121,"state":121,"zip":139,"country":91,"contacts":140,"geoPoint":146},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","10065",[141,143],{"name":94,"role":95,"phone":96,"email":142},"ShahNutrivention@mskcc.org",{"name":144,"role":95,"phone":145},"Tamanna Haque, MD","646-608-4166",{"lat":147,"lon":148},40.71427,-74.00597,{"facility":150,"status":8,"city":151,"state":121,"zip":152,"country":91,"contacts":153,"geoPoint":155},"Memorial Sloan Kettering Nassau (All Protocol Activities)","Uniondale","11553",[154],{"name":94,"role":95,"phone":96},{"lat":156,"lon":157},40.70038,-73.59291,[159,160],{"name":94,"role":95,"phone":96,"email":142},{"name":144,"role":95,"phone":145},[162],{"name":94,"affiliation":13,"role":163},"PRINCIPAL_INVESTIGATOR",[],[166],{"label":13,"url":167},"https:\u002F\u002Fwww.mskcc.org\u002F",{"nct_id":4,"conditions":169,"biomarkers":171},[170,18],"Clonal Cytopenia of Undetermined Significance",[172],"Somatic Variation",{"nct_id":4,"found":174,"summary":175,"prompt_version":185},true,{"design":176,"status":177,"heading":178,"summary":179,"follow_up":180,"word_count":181,"commitments":182,"compensation":183,"drugs_mentioned":184},"This is an interventional study, meaning you will receive a specific intervention. It plans to enroll 36 participants.","completed","Dietary Study for Clonal Hematopoiesis","This study is looking at whether a high-fiber plant-based diet (HFPBD) can improve your quality of life if you have clonal hematopoiesis (CH). CH is a condition where some of your blood stem cells have genetic changes. The study will provide you with 12 frozen prepared high-fiber plant-based meals per week and encourage fermented foods. You'll also be recommended to take a weekly vitamin B12 supplement. To join, you must have confirmed CH through genetic testing of your blood or bone marrow. The researchers will measure success by comparing improvements in your quality of life, which will be assessed using surveys over 12 weeks. The current recruitment status is unclear, and the study plans to enroll 36 people.","Your quality of life will be measured for up to 12 weeks.",118,"You will receive 12 frozen prepared meals weekly and be encouraged to eat fermented foods. You will also be recommended to take a weekly vitamin B12 supplement and complete surveys to measure your quality of life.","Not stated in the trial record.",[30,35,44],"v2"]