Clinical trial NCT03735186: Exercise and Coronary Heart Disease Risk Markers in Male Smokers and Non-Smokers
Official title: Acute Exercise and Coronary Heart Disease Risk Markers in Healthy Male Smokers and Non-Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Coronary Heart Disease
Cardiovascular Risk Factor
Insulin Resistance
Oxidative Stress
Inflammation
Keywords: Coronary heart disease
Exercise
Inflammation
Postprandial lipaemia
Smoking
Lead sponsor: Loughborough University
Sponsor class: OTHER
Collaborators: name: University of Leicester
name: University Hospitals, Leicester
First posted: 2018-11-08
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion criteria:

* 20- to 45-year-old healthy male smokers or non-smokers;
* Be able to exercise continuously for 1 hour;
* Body mass index between 18.5 and 29.9 kg/m2;
* Weight stable for the past 3 months;
* No known contradictions to maximal exertion exercise (e.g., recent musculoskeletal injury, congenital heart disease).
* A regular cigarette smoker or non-smoker for the last 12 months according to the definition below;

The National Health Interview Survey (NHIS) definitions will be used to identify cigarette smokers and non-smokers (Link: NHIS Adult Tobacco Use):

1. Current smokers will be defined as an adult who has smoked ≥100 cigarettes in their lifetime and who currently smokes cigarettes every day.
2. Non-smokers will be defined as an adult who has never smoked or who has smoked \< 100 cigarettes in their lifetime

The following questions will determine the eligibility and group allocation:

1. Do you currently smoke cigarettes on a daily basis?
2. Have you smoked at least 100 cigarettes in your entire life?

If the person answers YES to Q1 and YES to Q2 they are eligible for the study and will be allocated to the smokers group.

If the person answers NO to Q1 and NO to Q2 they are eligible for the study and will be allocated to the non-smokers group.

Individuals answering any other combination (YES, NO or NO, YES) will not be eligible to take part in the study.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Triacylglycerol concentration
timeFrame: 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)
Secondary outcomes:
measure: Glucose concentration
timeFrame: 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)
measure: Insulin concentration
timeFrame: 8 hours (Plasma samples will be collected at 0 (fasted), 0.5, 1, 3, 4, 4.5, 6, 8 hours)
measure: Homeostasis model assessment of insulin resistance (HOMA-IR)
timeFrame: Fasting (Plasma samples will be collected at 0 (fasted) hours)
measure: Non-esterified fatty acids concentration
timeFrame: 8 hours (Plasma samples will be collected at 0 (fasted), 0.5, 1, 3, 4, 4.5, 6, 8 hours)
measure: Total cholesterol concentration
timeFrame: Fasting (Plasma samples will be collected at 0 (fasted) hours)
measure: High-density lipoprotein cholesterol concentration
timeFrame: Fasting (Plasma samples will be collected at 0 (fasted) hours)
measure: Low-density lipoprotein cholesterol concentration
timeFrame: Fasting (Plasma samples will be collected at 0 (fasted) hours)
measure: C-reactive protein concentration
timeFrame: 8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
measure: Interleukin-6 concentration
timeFrame: 8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
measure: Interleukin-10 concentration
timeFrame: 8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
measure: Tumor necrosis factor alpha concentration
timeFrame: 8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
measure: Peroxiredoxin-4 concentration
timeFrame: 8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
measure: Superoxide dismutase 3 concentration
timeFrame: 8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
measure: Systolic and diastolic blood pressure
timeFrame: 8 hours (Blood pressure will be measured at 0 (fasted), 1, 2, 3, 4, 5, 6, 7, 8 hours)
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: Loughborough University
state: Leicestershire
Study officials:
affiliation: Loughborough University
name: David Stensel
role: PRINCIPAL_INVESTIGATOR
affiliation: Loughborough University
name: Tareq Alotaibi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arjunan SP, Deighton K, Bishop NC, King J, Reischak-Oliveira A, Rogan A, Sedgwick M, Thackray AE, Webb D, Stensel DJ. The effect of prior walking on coronary heart disease risk markers in South Asian and European men. Eur J Appl Physiol. 2015 Dec;115(12):2641-51. doi: 10.1007/s00421-015-3269-7. Epub 2015 Oct 5.
citation: Arjunan SP, Bishop NC, Reischak-Oliveira A, Stensel DJ. Exercise and coronary heart disease risk markers in South Asian and European men. Med Sci Sports Exerc. 2013 Jul;45(7):1261-8. doi: 10.1249/MSS.0b013e3182853ecf.
citation: Miyashita M, Burns SF, Stensel DJ. Accumulating short bouts of brisk walking reduces postprandial plasma triacylglycerol concentrations and resting blood pressure in healthy young men. Am J Clin Nutr. 2008 Nov;88(5):1225-31. doi: 10.3945/ajcn.2008.26493.
citation: Alotaibi TF, Thackray AE, Roberts MJ, Alanazi TM, Bishop NC, Wadley AJ, King JA, O'Donnell E, Steiner MC, Singh SJ, Stensel DJ. Acute Running and Coronary Heart Disease Risk Markers in Male Cigarette Smokers and Nonsmokers: A Randomized Crossover Trial. Med Sci Sports Exerc. 2021 May 1;53(5):1021-1032. doi: 10.1249/MSS.0000000000002560.