Clinical Trials Directory

Trials / Completed

CompletedNCT03735186

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
Loughborough University · Academic / Other
Sex
Male
Age
20 Years – 45 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALExercise60 min treadmill exercise performed at 60% of maximum oxygen uptake.

Timeline

Start date
2017-08-04
Primary completion
2018-10-02
Completion
2018-10-02
First posted
2018-11-08
Last updated
2018-11-09

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03735186. Inclusion in this directory is not an endorsement.