跳至主要内容
临床试验/NCT07649148
NCT07649148招募中不适用

Dietary Optimization Through Tracking and Integrated Evaluation

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Document Ultraprocessed Food (UPF) Consumption in HF

研究概览

简要总结

Emerging evidence links ultra processed foods (UPFs) to adverse cardiovascular outcomes. UPFs are often high in sodium, unhealthy fats and added sugars, while being low in essential nutrients and fiber. UPFs contribute to systemic inflammation, fluid retention, and metabolic dysfunction-key drivers of HF and kidney disease progression. Traditional dietary counseling often lacks specificity around food processing levels. Furthermore, the majority of nutrition studies relied on extensive self-reported dietary recall food frequency questionnaires (FFQ) that are subjective, often labor intensive, and difficult to implement practically in the clinical setting. As such, researchers have developed metabolite scores from blood and urine samples to help quantify UPF consumption, which has the promise to better guide dietary counseling and track process. Therefore, the aim of this study is to evaluate the feasibility and physiological impact of a structured UPF-reduction dietary intervention in patients with HF, leveraging both digital dietary tools (Cronometer) and biomarker assessments.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • •Adults (≥18 years) with NYHA Class II-III HF
  • •Able to use Cronometer to track dietary intake and able to prepare food at home independently (able to modify dietary intake)

排除标准

  • •History of heart transplant or LVAD implant
  • •Unable or unwilling to follow dietary coaching for UPF reduction
  • •eGFR <30 ml/kg/1.73m2

结局指标

主要结局

Document Ultraprocessed Food (UPF) Consumption in HF

时间窗: 5 years

To improve understanding of UPF consumption (type(s), amount(s), etc.) in patients with heart failure

Change in ultraprocessed food (UPF) consumption in heart failure patients

时间窗: 5 Years

To investigate the potential for reducing UPF consumption via dietary counseling, Cronometer tracking, and structured patient feedback.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wilson Tang

Staff, Section of Heart Failure and Cardiac Transplantation Medicine & Staff, Cleveland Clinic Research

The Cleveland Clinic

研究点 (1)

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