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临床试验/NCT05279014
NCT05279014已完成不适用

The Effect of Fasted Exercise on LDL-cholesterol in Men and Women

University of Bath2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2022年3月30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
29
试验地点
2
主要终点
Change in fasting plasma LDL-C concentrations at week 12

研究概览

简要总结

Cardiovascular disease (CVD) is the leading cause of death in the UK and worldwide with low density lipoprotein cholesterol (LDL-C) being one of the most important modifiable risk factors. Physical activity is inexpensive and research shows that it consistently improves high density lipoprotein and triglyceride concentrations. However, fails to improve LDL-C concentrations. Preliminary research suggests fasted exercise could potentially improve LDL-C concentrations. The majority of research in these areas have also mostly been done in males with the results generalised to females. As it is known that lipid metabolism and CVD risk is different between sexes it is possible that the response to fasted exercise may also be different between sexes. This aim of this study is to assess the effect of physical activity performed before or after a meal on plasma LDL-C concentrations in men and women and explore sex differences. The study will also assess the effect of fasted exercise on other CVD risk factors.

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
25 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-65 years
  • Body mass index 20-40kg/m2
  • Physically inactive (exercise for less than 150 minutes per week)

排除标准

  • Weight instability (>5kg change in body mass over last 6 months)
  • Diagnosis of diabetes or CVD
  • Pregnant or lactating
  • Any medical condition or medication that could introduce bias into the study (eg. lipid disorders, lipid or glucose metabolism altering medications eg statins)

结局指标

主要结局

Change in fasting plasma LDL-C concentrations at week 12

时间窗: Baseline and week 12

Fasting plasma LDL-cholesterol concentrations (mmol/L)

次要结局

  • Change in fasting plasma total cholesterol concentrations at week 4(Baseline and week 4)
  • Change in fasting plasma triglyceride concentrations at week 12(Baseline and week 12)
  • Change in fasting plasma triglyceride concentrations at week 4(Baseline and week 4)
  • Change in fasting plasma C-reactive protein concentrations at week 12(Baseline and week 12)
  • Change in 7-day standard deviation of interstitial glucose concentration at week 12(Baseline and Week 12)
  • Change in fasting plasma total cholesterol concentrations at week 12(Baseline and week 12)
  • Change in fasting plasma apolipoprotein B concentrations at week 12(Baseline and week 12)
  • Change in fasting plasma apolipoprotein B concentrations at week 4(Baseline and week 4)
  • Change in fasting plasma glucose concentrations at week 4(Baseline and week 4)
  • Change in fasting plasma HDL-C concentrations at week 12(Baseline and week 12)
  • Change in fasting plasma insulin concentrations at week 12(Baseline and week 12)
  • Change in fasting plasma non-esterified fatty acid concentrations at week 12(Baseline and week 12)
  • Change in 7-day mean amplitude of glycaemic excursions for interstitial glucose at week 12(Baseline and week 12.)
  • Change in fasting plasma C-reactive protein concentrations at week 4(Baseline and week 4)
  • Change in fasting plasma insulin concentrations at week 4(Baseline and week 4)
  • Change in fasting plasma non-esterified fatty acid concentrations at week 4(Baseline and week 4)
  • Change in 7-day mean interstitial glucose concentration at week 12(Baseline and week 12)
  • Change in fasting plasma LDL-C concentrations at week 4(Baseline and week 4)
  • Change in fasting plasma HDL-C concentrations at week 4(Baseline and week 4)
  • Change in fasting plasma glucose concentrations at week 12(Baseline and week 12)
  • Change in 7-day coefficient of variation for interstitial glucose concentration at week 12(Baseline and week 12.)

研究者

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

Louise Bradshaw

PhD Student

University of Bath

研究点 (2)

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