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临床试验/NCT03952000
NCT03952000已完成不适用

Influence of Prior Walking on Endothelial Function and Coronary Heart Disease Risk Markers in Centrally Obese South Asian and White European Men

Loughborough University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年1月3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
30
试验地点
2
主要终点
Triacylglycerol changes in response to exercise and feeding

研究概览

简要总结

The present study will investigate the effect of prior walking on postprandial metabolism and endothelial function in centrally obese South Asian and White European men.

Participants will complete two, 2-day trials in a random, crossover design separated by at least a week.

On day 1, participants will either rest or complete a 60 minute walk at 60% maximal oxygen uptake. On day 2, participants will arrive at 08:00 having fasted overnight and a baseline venous blood sample and endothelial function measurement will be taken. Participants will consume a high-fat breakfast and lunch and 12 subsequent venous blood samples will be taken throughout the day at standardised intervals to measure a variety of coronary heart disease risk markers. A second endothelial function measurement will be completed 2 hours after the breakfast. Blood pressure will be measured every hour.

It is expected that the South Asian participants will have impaired metabolism and endothelial function compared to their European counterparts but the bout of exercise performed on day 1 will mitigate these responses.

详细描述

South Asians have a higher-than-average risk of coronary heart disease. The reasons for this are unclear, but physical inactivity and/or poor responsiveness to exercise may play a role. It is important to understand the effect of exercise on endothelial function and coronary heart disease risk markers in the hope that exercise can be prescribed as an effective treatment to mitigate endothelial dysfunction and the risk of heart disease.

Previous research from the investigators' laboratory has indicated that postprandial metabolism is impaired in South Asian men, but this, and other coronary heart disease risk markers, can be improved with acute exercise. However, the previous research was conducted in apparently healthy South Asian and White European men. The investigators now wish to quantify and compare the coronary heart disease risk marker and endothelial function response to acute exercise in centrally obese South Asian and White European individuals who are at a higher risk for diabetes and cardiovascular disease.

On visit 1, participants will attend the laboratory to undergo preliminary assessments and to be familiarised with the laboratory environment and study procedures. Specifically, health status, habitual physical activity, dietary habits and anthropometric data (height, weight, waist and hip circumference, body fat) will be collected. A HbA1c test will be performed to check participants are not diabetic. The modified Bruce Treadmill test will be performed to predict maximal oxygen uptake.

On visit 2, participants will undergo a magnetic resonance imaging (MRI) scan to quantify regional body composition comprising abdominal subcutaneous adipose tissue, visceral adipose tissue, liver fat percentage, thigh intramuscular adipose tissue and thigh muscle volume.

On visits 3-6 participants will complete two, 2-day trials in a random, crossover design separated by at least 1 week. On day 1 of both trials, participants will arrive fasted at 08:00 and a baseline blood sample, blood pressure and endothelial function measurement will be taken. Participants will consume a standardised high fat breakfast at 09:00 and lunch at 13:00. At 15:30 the participants will walk for 60 minutes at 60% maximal oxygen uptake and complete a second endothelial function measurement at 16:45. Participants will leave the laboratory with a standardised evening meal to consume before 22:00. The control trial will be the same, except no exercise will be performed.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 18 to 60 year old South Asian and White European men;
  • Centrally obese (waist circumference >90cm for South Asians, >94cm for White Europeans);
  • Weight stable for the past 3 months;
  • Non-smokers;
  • No known contradictions to maximal exertion exercise.

排除标准

  • Musculoskeletal injury that has affected normal ambulation within the last month;
  • Congenital heart disease;
  • Any muscle or bone injuries that do not allow them to walk on a treadmill;
  • Uncontrolled exercise-induced asthma;
  • Coagulation or bleeding disorders;
  • Diabetes (metabolism will be different to non-diabetics potentially skewing the data);
  • Taking any medication that might influence fat metabolism;
  • Taking any medication that might influence blood glucose (e.g., insulin for diabetes);
  • Heart conditions;
  • Dieting or restrained eating behaviours;
  • Weight fluctuation greater than 3 kg in the previous 3 months to study enrolment;
  • A food allergy.

结局指标

主要结局

Triacylglycerol changes in response to exercise and feeding

时间窗: Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 1.75hours, 2hours, 3hours, 4hours, 5hours, 5.5hours, 5.75hours, 6hours, 7hours, 8hours and 9hours.

Fasting on day 1 and 2. Time-course of plasma triacylglycerol concentrations in response to exercise and/or feeding on day 2.

Endothelial function changes in response to exercise and feeding

时间窗: Day 1 fasting and 8.75hours. Day 2 fasting and 2.5hours.

Changes in endothelial function via flow-mediated dilatation in response to feeding and exercise.

次要结局

  • Insulin changes in response to exercise and/or feeding(Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 2hours, 4hours, 5hours, 5.5hours, 7hours, 8hours.)
  • Glucose changes in response to exercise and/or feeding(Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 1.75hours, 2hours, 3hours, 4hours, 5hours, 5.5hours, 5.75hours, 6hours, 7hours, 8hours and 9hours.)
  • High-density lipoprotein cholesterol(Day 1 fasting. Day 2 fasting.)
  • Low-density lipoprotein cholesterol(Day 1 fasting. Day 2 fasting.)
  • Superoxide dismutase 3(Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.)
  • Blood pressure changes in response to exercise and/or feeding(Day 1 fasting. Day 2 fasting (0 hour point) and 1hours, 2hours, 3hours, 4hours, 5hours, 6hours, 7hours, 8hours and 9hours.)
  • Total cholesterol(Day 1 fasting. Day 2 fasting.)
  • Non-esterified fatty acids changes in response to exercise and/or feeding(Day 1 fasting. Day 2 fasting (0 hour point), 1.5hours, 2hours, 4hours, 5hours, 5.5hours, 7hours and 9hours.)
  • C-Reactive protein changes in response to exercise and/or feeding(Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.)
  • Interleukin-6 changes in response to exercise and/or feeding(Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.)
  • Tumor Necrosis Factor concentrations(Day 1 fasting. Day 2 fasting.)
  • Peroxiredoxin-4 changes in response to exercise and/or feeding(Day 1 fasting. Day 2 fasting (0 hour point), 3hours, 6hours and 8hours.)

研究者

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

Matthew Roberts

Principal investigator

Loughborough University

研究点 (2)

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