A Decentralized High-Fiber Dietary Intervention Trial in Clonal Hematopoiesis - NUTRIVENTION-CH
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 7
- 主要终点
- compare the rates of improvement in Quality Of Life
研究概览
简要总结
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/surveys.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/m^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 <30 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.
排除标准
- •Prior MDS/AML directed therapy
- •Chemotherapy, radiation, or immunotherapy within the past year (surgical- resection only or other cancer/precancer 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/excluded 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/or tree nuts, such as cashews are not eligible.
研究组 & 干预措施
High Fiber Plant-Based Diet
Participants will have a phone call or video call with a dietitian every 2 weeks for the first 12 weeks, every 4 weeks from Weeks 13-24, and every 8 weeks from Weeks 25-52.
Participants will receive high-fiber plant-based meals for 12 weeks
干预措施: high-fiber plant-based meals (Other)
High Fiber Plant-Based Diet
Participants will have a phone call or video call with a dietitian every 2 weeks for the first 12 weeks, every 4 weeks from Weeks 13-24, and every 8 weeks from Weeks 25-52.
Participants will receive high-fiber plant-based meals for 12 weeks
干预措施: fermented foods (Other)
High Fiber Plant-Based Diet
Participants will have a phone call or video call with a dietitian every 2 weeks for the first 12 weeks, every 4 weeks from Weeks 13-24, and every 8 weeks from Weeks 25-52.
Participants will receive high-fiber plant-based meals for 12 weeks
干预措施: supplements (Dietary Supplement)
High Fiber Plant-Based Diet
Participants will have a phone call or video call with a dietitian every 2 weeks for the first 12 weeks, every 4 weeks from Weeks 13-24, and every 8 weeks from Weeks 25-52.
Participants will receive high-fiber plant-based meals for 12 weeks
干预措施: surveys (Other)
Usual care arm
Participants will have phone calls with a member of the study team every 4 weeks for the first 12 weeks. After the first 12 weeks, participants will have a phone call or video call with a dietitian at Weeks 13 and 53 (end of study).
干预措施: surveys (Other)
结局指标
主要结局
compare the rates of improvement in Quality Of Life
时间窗: up to 12 weeks
using the Quality of Life Global Health Status at W13D1 Scoring will be based on standard EORTC criteria
次要结局
未报告次要终点