跳至主要内容
临床试验/NCT05904639
NCT05904639尚未招募早期 1 期

Multivariable Transcriptomic Analysis, Dietary Patterns and Cardiovascular Risk in African Americans

Morehouse School of Medicine2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年7月最近更新:
适应症

试验速览

阶段
早期 1 期
状态
尚未招募
入组人数
15
试验地点
2
主要终点
Differential changes in gene expression from baseline to end of study.

研究概览

简要总结

Our study will determine if a high quality AHA plant-based diet intervention can promote a genetic signature that is protective against CVD. Our development of GE mutational signatures in Blacks/African Americans with a high CVD burden can inform of changes patients can implement in their diet and lifestyle to decrease the CVD risk burden.

详细描述

Cardiovascular disease (CVD) is the leading cause of death in the US and worldwide, contributing to 1 in every 4 deaths. Compared to European Americans, African Americans have higher risks for cardiometabolic conditions. Our study aim is to determine if a high-quality American Heart Association (AHA) plant-based diet intervention can promote a genetic mutational signature that is protective against CVD. We will enroll 15 Black/African American cardiac patients from Grady Memorial Hospital, Atlanta, GA. We will investigate from baseline to 3 months how the AHA plant-based diet intervention affected the regulation of several genes that are differentially expressed (DEG) and cluster together within biological pathways. We will integrate this information with WGS data, clinical factors, and ASA24-hour recalls. We expect that the AHA plant-based diet will be protective against deleterious DEG patterns that promote development of CVD. Our DEG mutational signatures in Black/African Americans with a high CVD burden can inform of changes patients can implement in their diet to decrease CVD risk burden. Our study will also fill gaps in providing new information regarding novel genomic-biological signatures with diet predictors and risk factors of CVD that can be useful in designing prevention and treatment strategies in precision medical care.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

盲法说明

masking of participants to biostatistician.

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • All other racial groups
  • Age < 40 years
  • Normal weight (BMI 18.5-24.9 kg/m2)
  • Normal waist circumference < 40 inches (<102 cm) for men and < 35 inches (<88 cm) for women
  • < 3 abnormal metabolic traits/ diagnosed cardiometabolic diseases
  • Orthopedic conditions (i.e., recent hip or knee replacement)
  • Paralysis
  • Diagnosed severe dementia
  • End-stage renal disease: chronic kidney disease: stage 3 or 4
  • Congestive heart failure (advanced stage and not fluid-stable)
  • Chronic fluid retention

结局指标

主要结局

Differential changes in gene expression from baseline to end of study.

时间窗: 3 months

Differential changes in gene expression will be assessed by statistics. These changes will be assessed in response to changes in cardiovascular risk factors when the participants use an AHA plant-based diet.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验