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临床试验/NCT05449496
NCT05449496进行中(未招募)不适用

Dietary Intervention to Improve Kidney Transplant Outcomes

University of California, Davis1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2022年6月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
49
试验地点
1
主要终点
Cardiometabolic health measures

研究概览

简要总结

Randomized controlled trial of a curriculum intervention teaching patients to eat a whole-food plant-based dietary pattern versus standard of care in kidney transplant recipients within the first few months of transplant

详细描述

A whole-food plant-based dietary pattern has emerged as fundamental in preventing and treating many of the lifestyle-related diseases of Western medicine, including cardiovascular disease, diabetes, hyperlipidemia, obesity, hypertension, chronic kidney disease and certain cancers. These diseases often occur or recur in the post-transplant population, leading to patient and graft loss. However, dietary education for kidney transplant recipients is not standardized and many patients remain ignorant about optimum healthy dietary practices. These patients are further challenged by the common occurrence of electrolyte derangements that require dietary restrictions. We propose a randomized controlled trial of a dietary intervention that focuses on whole-food plant-based eating in the kidney transplant population, testing this dietary pattern's impact on recipient health outcomes. This study addresses the critical need for cost-effective and safe strategies to improve health outcomes in transplant recipients and preserve kidney graft function. We have assembled an interdisciplinary team with expertise in transplant nephrology, lifestyle medicine, plant-based renal nutrition, health coaching and biostatistics to investigate the following aims: (1) to test the efficacy of a whole-food plant-based diet on improving kidney recipient cardiovascular and metabolic health and kidney allograft function, (2) to test the effect of a whole-food plant-based diet on kidney recipient post-transplant complication rates, and (3) to test the feasibility of a dietary education program on kidney transplant recipients' ability to adhere to a whole-food plant-based diet, all within a 12-month randomized controlled trial of plant-based diet versus usual care. Dietary counseling will focus on eating a predominantly plant-based diet comprised of fruits, vegetables, whole grains and legumes, and low in animal products, fats and processed foods. Dietary counseling will occur in group-based sessions weekly for the first month, then biweekly for 5 months. Patients will be followed for 12 months. This study has the potential to establish dietary intervention as a way to prolong kidney graft survival and to improve overall health and survival in kidney transplant recipients. This study will also launch a cohort of patients whose dietary patterns can be followed and compared over time, providing groundwork for further research into the connections between diet and kidney-related outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

  • •Kidney transplant recipient aged 18 or greater
  • •Post-transplant months 2-12
  • •eGFR >= 20 mL/min
  • •Have at least one of the following:
  • •Hypertension history (BP >= 150/90 or on BP medications)
  • •Hyperglycemia history (FBG >= 100 x 2 or on diabetes medications)
  • •Overweight (BMI >= 25)

排除标准

  • •Rejection episode before study enrollment
  • •Gastrointestinal feeding tube or requires alternative nutrition
  • •Unable to understand or read English
  • •Unable to attend online classes or complete study questionnaires independently
  • •Already eating a plant-based diet
  • •Unwilling to make dietary changes
  • •Pregnant or breastfeeding
  • •Unable to consent
  • •Blindness
  • •Prisoners

研究组 & 干预措施

Control

No Intervention

Intervention

Experimental

干预措施: Dietary Education Curriculum (Behavioral)

结局指标

主要结局

Cardiometabolic health measures

时间窗: 1 year

Proportion of individuals achieving normotension, normoglycemia and weight reduction

Post-transplant complications rates

时间窗: 1 year

Composite incidence of emergency medical visits, hospitalizations and infections

次要结局

  • Dietary complications(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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