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临床试验/NCT05216796
NCT05216796已完成不适用

Diet Intervention to Promote Liver and Brain Health in Adults With Non-alcoholic Fatty Liver Disease

University of Texas at Austin2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2022年5月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
2
主要终点
Decrease in Liver Fat

研究概览

简要总结

People with liver disease report difficulties with attention and problem-solving skills. Diet plays an important role in the development of liver disease and/or pre-diabetes. The purpose of this study is to examine whether participation in a brief diet intervention (up to 3 weeks) can improve brain and liver health and function.

详细描述

The importance of liver function for brain and cognitive health is undeniable. Specifically, adults with chronic liver diseases such as non-alcoholic fatty liver disease (NAFLD), a factor of metabolic syndrome (MetS), experience a range of symptoms including problems with attention, problem solving skills and executive function. Importantly, diet plays a role in the development of NAFLD. The investigators propose to be the first to demonstrate that Metabolic syndrome-related brain vulnerability, in the form of elevated free cerebral glutamate, is related to hepatic triglyceride level, through experimental manipulation of liver fat and multiorgan imaging. The investigators seek to improve liver health by altering diet content in a block randomized feeding trial. The investigators selected a low-carbohydrate (<30 g/d) diet (LoCHO) to reduce liver fat and a low-calorie (LoCAL) diet as a control for weight loss. The investigators hypothesize that LoCHO diet will improve cognitive performance by improving liver health and thus, brain health. This work may provide a way to support brain function in MetS and delay cognitive decline.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • at least 40 years of age
  • English speakers
  • show a minimum of 5% hepatic triglyceride level on liver imaging
  • have not taken part in a weight loss/dietary intervention within 6 months
  • not currently adhering to a low-carbohydrate diet (e.g., Atkins, Paleo)

排除标准

  • younger than 40 years of age
  • have a history of neurological disease (e.g. stroke, seizure disorder)
  • psychiatric illness (e.g. schizophrenia, bipolar disorder)
  • harmful alcohol use (AUDIT-C score >5)
  • morbid obesity (BMI>40)
  • MRI contraindications

结局指标

主要结局

Decrease in Liver Fat

时间窗: Liver fat will be measured at baseline (week 0) and after at least 2 weeks (up to 3 weeks) on the designated diet. The liver 1H MRS scans will happen during Visit 3 (baseline) and Visit 4 (at least 2 weeks on the diet).

Hepatic triglyceride level will be assessed using liver 1H MRS.

Decrease in cerebral gluatamate

时间窗: Cerebral glutamate will be measured at baseline (week 0) and after at least 2 weeks (up to 3 weeks) on the designated diet. The brain 1H MRS scans will happen during Visit 3 (baseline) and Visit 4 (at least 2 weeks on the diet).

Cerebral glutamate levels will be measured using 1H MRS.

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

Andreana P. Haley

Professor in Clinical Psychology

University of Texas at Austin

研究点 (2)

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