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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03735186
• Other study ID #: R17-P055
• Status: Completed
• Phase: N/A
• Start date: August 4, 2017
• Est. completion date: October 2, 2018

Study information

• Verified date: November 2018
• Source: Loughborough University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2, 2018
• Est. primary completion date: October 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Cigarette Smoking
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Inflammation
• Insulin Resistance
• Myocardial Ischemia
• Oxidative Stress

Intervention

Behavioral:
• Exercise
60 min treadmill exercise performed at 60% of maximum oxygen uptake.

Locations

Country	Name	City	State
United Kingdom	Loughborough University	Loughborough	Leicestershire

Sponsors (3)

Lead Sponsor	Collaborator
Loughborough University	University Hospitals, Leicester, University of Leicester

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Triacylglycerol concentration	Total area under the plasma triacylglycerol concentration versus time curve on day 2	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	Glucose concentration	Time-course of plasma glucose concentrations on day 2 of the exercise and control trials.	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	Insulin concentration	Time-course of plasma insulin concentrations on day 2 of the exercise and control trials.	8 hours (Plasma samples will be collected at 0 (fasted), 0.5, 1, 3, 4, 4.5, 6, 8 hours)
Secondary	Homeostasis model assessment of insulin resistance (HOMA-IR)	Homeostasis model assessment of insulin resistance (HOMA-IR) on day 2 of the exercise and control trials using fasting glucose and insulin concentrations.	Fasting (Plasma samples will be collected at 0 (fasted) hours)
Secondary	Non-esterified fatty acids concentration	Time-course of plasma non-esterified fatty acid concentrations on day 2 of the exercise and control trials.	8 hours (Plasma samples will be collected at 0 (fasted), 0.5, 1, 3, 4, 4.5, 6, 8 hours)
Secondary	Total cholesterol concentration	Circulating concentrations of plasma total cholesterol in the fasted state on day 2 of the exercise and control trials.	Fasting (Plasma samples will be collected at 0 (fasted) hours)
Secondary	High-density lipoprotein cholesterol concentration	Circulating concentrations of plasma high-density lipoprotein cholesterol in the fasted state on day 2 of the exercise and control trials.	Fasting (Plasma samples will be collected at 0 (fasted) hours)
Secondary	Low-density lipoprotein cholesterol concentration	Circulating concentrations of plasma low-density lipoprotein cholesterol in the fasted state on day 2 of the exercise and control trials.	Fasting (Plasma samples will be collected at 0 (fasted) hours)
Secondary	C-reactive protein concentration	Time-course of plasma C-reactive protein concentrations on day 2 of the exercise and control trials.	8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
Secondary	Interleukin-6 concentration	Time-course of plasma interleukin-6 concentrations on day 2 of the exercise and control trials.	8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
Secondary	Interleukin-10 concentration	Time-course of plasma interleukin-10 concentrations on day 2 of the exercise and control trials.	8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
Secondary	Tumor necrosis factor alpha concentration	Time-course of plasma tumor necrosis factor alpha concentrations on day 2 of the exercise and control trials.	8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
Secondary	Peroxiredoxin-4 concentration	Time-course of plasma peroxiredoxin-4 concentrations on day 2 of the exercise and control trials.	8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
Secondary	Superoxide dismutase 3 concentration	Time-course of plasma superoxide dismutase 3 concentrations on day 2 of the exercise and control trials.	8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
Secondary	Systolic and diastolic blood pressure	Time-course of systolic and diastolic blood pressure on day 2 of the exercise and control trials.	8 hours (Blood pressure will be measured at 0 (fasted), 1, 2, 3, 4, 5, 6, 7, 8 hours)