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临床试验/NCT03737071
NCT03737071进行中(未招募)不适用

The Effects of Low Carbohydrate Diet on Liver Fat Content and Mitochondrial Fluxes

Helsinki University Central Hospital2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
10
试验地点
2
主要终点
Change in hepatic mitochondrial flux

研究概览

简要总结

The purpose of this study is to examine whether a low carbohydrate diet as compared to simple calorie restriction decreases hepatic lipid content and changes hepatic mitochondrial flux in humans.

详细描述

In this study, the investigators will examine whether a low carbohydrate diet as compared to simple calorie restriction will change hepatic lipid content and mitochondrial flux in humans. Before and after a low carbohydrate diet and a simple calorie restriction intervention, rates of hepatic mitochondrial flux will be assessed using positional isotopomer analysis of 3-13C-lactate during a 3 hour basal period. Rates of whole body ketogenesis will be determined using [13C4]β-hydroxybutyrate, and whole body glucose metabolism will be measured using [2H7]glucose. Body composition will be determined with bioelectrical impedance; hepatic lipid content will be measured with MRS. Whole-body oxidation of lipids, carbohydrates and protein will be determined using indirect calorimetry.

研究设计

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

入排标准

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

入选标准

  • Age 18-70
  • Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent

排除标准

  • chronic liver disease other than NAFLD
  • chronic disease associated with hepatic steatosis such as diabetes mellitus
  • use of drugs known to affect hepatic steatosis
  • contraindications for MRI
  • pregnancy or nursing at the time of the study

结局指标

主要结局

Change in hepatic mitochondrial flux

时间窗: 1 week

Change in the rate of hepatic mitochondrial flux (Vcs) will be assessed using 3-13C-lactate infusion.

Change in hepatic triglyceride content

时间窗: 1 week

Change in hepatic triglyceride content will be measured using 1H magnetic resonance spectroscopy (MRS).

次要结局

  • Change in beta-hydroxybutyrate production rate(1 week)
  • Change in glucose production rate(1 week)

研究者

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

Panu Luukkonen

MD, PhD

Helsinki University Central Hospital

研究点 (2)

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