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

NCT03735186 | Completed

• 1 other identifier: R17-P055
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoking; Coronary Heart Disease; Cardiovascular Risk Factor; Insulin Resistance; Oxidative Stress; Inflammation

Keywords

Coronary heart disease; Exercise; Inflammation; Postprandial lipaemia; Smoking

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• 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)

• Homeostasis model assessment of insulin resistance (HOMA-IR)

  Fasting (Plasma samples will be collected at 0 (fasted) 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)

Study Arms (2)

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.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

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

Exercise

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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):
• Current smokers will be defined as an adult who has smoked ≥100 cigarettes in their lifetime and who currently smokes cigarettes every day.
• 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:
• Do you currently smoke cigarettes on a daily basis?
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loughborough University: lead
• University of Leicester: collaborator
• University Hospitals, Leicester: collaborator

Study Sites (1)

Loughborough University

Loughborough, Leicestershire, LE11 3TU, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 26438068 BACKGROUND

• 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.

  PMID: 23470315 BACKGROUND

• 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.

  PMID: 18996856 BACKGROUND

• 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.

  PMID: 33196606 DERIVED

MeSH Terms

Conditions

Cigarette Smoking; Coronary Disease; Insulin Resistance; Inflammation; Motor Activity; Smoking

Interventions

Exercise

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• David Stensel

  Loughborough University

  PRINCIPAL INVESTIGATOR

• Tareq Alotaibi

  Loughborough University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 8, 2018
• Study Start: August 4, 2017
• Primary Completion: October 2, 2018
• Study Completion: October 2, 2018
• Last Updated: November 9, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)