A Dietary Study for People With Clonal Hematopoiesis
2026年5月12日 更新者：Memorial Sloan Kettering Cancer Center
A Decentralized High-Fiber Dietary Intervention Trial in Clonal Hematopoiesis - NUTRIVENTION-CH
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.
研究概览
地位
招聘中
条件
研究类型
介入性
注册 (估计的)
36
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Urvi Shah, MD
- 电话号码：646-608-3713
- 邮箱：ShahNutrivention@mskcc.org
研究联系人备份
- 姓名：Tamanna Haque, MD
- 电话号码：646-608-4166
学习地点
-
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New Jersey
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Basking Ridge、New Jersey、美国、07920
- 招聘中
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
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接触：
- Urvi Shah, MD
- 电话号码：646-608-3713
-
Middletown、New Jersey、美国、07748
- 招聘中
- Memorial Sloan Kettering Monmouth (All Protocol Activities)
-
接触：
- Urvi Shah, MD
- 电话号码：646-608-3713
-
Montvale、New Jersey、美国、07645
- 招聘中
- Memorial Sloan Kettering Bergen (All Protocol Activities)
-
接触：
- Urvi Shah, MD
- 电话号码：646-608-3713
-
-
New York
-
Commack、New York、美国、11725
- 招聘中
- Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
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接触：
- Urvi Shah, MD
- 电话号码：646-608-3713
-
Harrison、New York、美国、10604
- 招聘中
- Memorial Sloan Kettering Westchester (All Protocol Activities)
-
接触：
- Urvi Shah, MD
- 电话号码：646-608-3713
-
New York、New York、美国、10065
- 招聘中
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
-
接触：
- Urvi Shah, MD
- 电话号码：646-608-3713
- 邮箱：ShahNutrivention@mskcc.org
-
接触：
- Tamanna Haque, MD
- 电话号码：646-608-4166
-
Uniondale、New York、美国、11553
- 招聘中
- Memorial Sloan Kettering Nassau (All Protocol Activities)
-
接触：
- Urvi Shah, MD
- 电话号码：646-608-3713
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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 |
A meal service will ship 12 frozen prepared meals per week to your home.
Fermented foods will be encouraged on the diet.
Fermented foods contain probiotics that help support a balanced gut microbiome and might improve overall digestion.
Patients will be recommended by research dietitian to take a weekly vitamin B12 supplement (at least 500 mcg weekly)
QOL will be measured with the EORTC QLQ C30
|
|
有源比较器：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).
|
QOL will be measured with the EORTC QLQ C30
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
compare the rates of improvement in Quality Of Life
大体时间：up to 12 weeks
|
using the Quality of Life Global Health Status at W13D1 Scoring will be based on standard EORTC criteria
|
up to 12 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Urvi Shah, MD、Memorial Sloan Kettering Cancer Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月4日
初级完成 (估计的)
2027年5月1日
研究完成 (估计的)
2027年5月1日
研究注册日期
首次提交
2026年5月7日
首先提交符合 QC 标准的
2026年5月12日
首次发布 (实际的)
2026年5月15日
研究记录更新
最后更新发布 (实际的)
2026年5月15日
上次提交的符合 QC 标准的更新
2026年5月12日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 26-086
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials.
The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov
when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required.
Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.
Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals.
Requests may be made to: crdatashare@mskcc.org.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.