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临床试验/NCT03735186
NCT03735186已完成不适用

Acute Exercise and Coronary Heart Disease Risk Markers in Healthy Male Smokers and Non-Smokers

Loughborough University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年8月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Triacylglycerol concentration

研究概览

简要总结

The present study will investigate the effect of acute exercise on fasting and postprandial risk markers for coronary heart disease (CHD) in healthy male cigarette smokers and non-smokers.

Participants will complete two, 2-day trials in a random crossover design separated by an interval of at least 1 week. On day 1, participants will rest (control) or complete 60 minute of treadmill exercise at 60% of maximum oxygen uptake (exercise). On day 2, participants will rest and consume two high fat meals (breakfast and lunch) over an 8-h period during which 13 venous blood samples and nine blood pressure measurements will be taken at pre-determined intervals.

It is hypothesised that men who smoke cigarettes will exhibit impaired fasting and postprandial metabolic risk markers compared to non-smokers, but a single bout of exercise will be equally, if not more, efficacious for improving the CHD risk factor profile in smokers than non-smokers.

详细描述

Cigarette smoking is a strong and independent risk factor for CHD and is associated with impaired postprandial metabolism. Previous studies suggest that postprandial metabolism and other risk markers for CHD can be improved with acute exercise in healthy non-smokers, but less is known about responses in cigarette smokers. Therefore, the present study will compare the effect of acute exercise on fasting and postprandial risk markers for CHD in healthy male cigarette smokers and non-smokers.

A total of 12 healthy male cigarette smokers and 12 healthy male non-smokers matched for age and body mass index will be recruited. Before the main experimental trials, participants will attend the laboratory for a preliminary visit to complete screening questionnaires and to undergo familiarisation, anthropometric measurements (stature, body mass, waist and hip circumference, body fat) and exercise testing to determine maximum oxygen uptake.

Participants will complete two, 2-day (08:00-17:00) experimental trials in a randomised cross over design: control and exercise. On day 1, participants will arrive at the laboratory at 08:00 having fasted overnight and a baseline fasting venous blood sample and blood pressure measurement will be taken. A high fat breakfast and lunch meal will be consumed at 08:30 and 12:00, respectively. The control and exercise trials will be identical, except a 60 min bout of treadmill exercise at 60% of maximum oxygen uptake will be performed at 14:30 in the exercise trial.

On day 2, participants will arrive at 08:00 having fasted overnight for 10 h and will rest in the laboratory until 17:00. Participants in the smokers group will be asked to stop smoking at 08:00. A high fat breakfast and lunch will be consumed at 09:00 and 13:00, respectively. Venous blood samples from a cannula will be collected in the fasted state and at 0.25, 0.5, 1, 2, 3, 4, 4.25, 4.5, 5, 6, 7 and 8 h after the breakfast meal. Resting arterial blood pressure will be measured in the fasted state and at hourly intervals thereafter.

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
20 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Not meeting the criteria for a smoker or non-smoker (defined above);
  • Current E-Cigarette smoker;
  • Musculoskeletal injury that has affected normal ambulation within the last month;
  • Any muscle or bone injuries that do not allow them to walk and run on a treadmill;
  • Uncontrolled exercise-induced asthma;
  • Heart conditions;
  • 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);
  • Dieting or restrained eating behaviours;
  • Weight fluctuation greater than 3 kg in the 3 months prior to study enrolment;
  • A food allergy.

研究组 & 干预措施

Control

No Intervention

Participants will rest in the laboratory on day 1 and day 2 (08:00-17:00). A high fat breakfast and lunch will be consumed on both days at pre-determined intervals.

Exercise

Experimental

Participants will complete 60 min of treadmill exercise on day 1 (14:30-15:30). Participants will rest in the laboratory for the remainder of day 1 and throughout day 2 (08:00-17:00). A high fat breakfast and lunch will be consumed on both days at pre-determined intervals.

干预措施: Exercise (Behavioral)

结局指标

主要结局

Triacylglycerol concentration

时间窗: 8 hours (Plasma samples will be collected at 0 (fasted), 0.25, 0.5, 1, 2, 3, 4, 4.25, 4.5, 5, 6, 7, 8 hours)

Total area under the plasma triacylglycerol concentration versus time curve on day 2

次要结局

  • High-density lipoprotein cholesterol concentration(Fasting (Plasma samples will be collected at 0 (fasted) hours))
  • Peroxiredoxin-4 concentration(8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours))
  • Homeostasis model assessment of insulin resistance (HOMA-IR)(Fasting (Plasma samples will be collected at 0 (fasted) hours))
  • C-reactive protein concentration(8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours))
  • Glucose concentration(8 hours (Plasma samples will be collected at 0 (fasted), 0.25, 0.5, 1, 2, 3, 4, 4.25, 4.5, 5, 6, 7, 8 hours))
  • Insulin concentration(8 hours (Plasma samples will be collected at 0 (fasted), 0.5, 1, 3, 4, 4.5, 6, 8 hours))
  • Non-esterified fatty acids concentration(8 hours (Plasma samples will be collected at 0 (fasted), 0.5, 1, 3, 4, 4.5, 6, 8 hours))
  • Total cholesterol concentration(Fasting (Plasma samples will be collected at 0 (fasted) hours))
  • Low-density lipoprotein cholesterol concentration(Fasting (Plasma samples will be collected at 0 (fasted) hours))
  • Interleukin-6 concentration(8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours))
  • Interleukin-10 concentration(8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours))
  • Tumor necrosis factor alpha concentration(8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours))
  • Superoxide dismutase 3 concentration(8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours))
  • Systolic and diastolic blood pressure(8 hours (Blood pressure will be measured at 0 (fasted), 1, 2, 3, 4, 5, 6, 7, 8 hours))

研究者

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

Tareq Alotaibi

Principal investigator

Loughborough University

研究点 (2)

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