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

Primary Purpose

Cigarette Smoking, Coronary Heart Disease, Cardiovascular Risk Factor

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise
Sponsored by
Loughborough University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cigarette Smoking focused on measuring Coronary heart disease, Exercise, Inflammation, Postprandial lipaemia, Smoking

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Loughborough University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Glucose concentration
Time-course of plasma glucose concentrations on day 2 of the exercise and control trials.
Insulin concentration
Time-course of plasma insulin concentrations on day 2 of the exercise and control trials.
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.
Non-esterified fatty acids concentration
Time-course of plasma non-esterified fatty acid concentrations on day 2 of the exercise and control trials.
Total cholesterol concentration
Circulating concentrations of plasma total cholesterol in the fasted state on day 2 of the exercise and control trials.
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.
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.
C-reactive protein concentration
Time-course of plasma C-reactive protein concentrations on day 2 of the exercise and control trials.
Interleukin-6 concentration
Time-course of plasma interleukin-6 concentrations on day 2 of the exercise and control trials.
Interleukin-10 concentration
Time-course of plasma interleukin-10 concentrations on day 2 of the exercise and control trials.
Tumor necrosis factor alpha concentration
Time-course of plasma tumor necrosis factor alpha concentrations on day 2 of the exercise and control trials.
Peroxiredoxin-4 concentration
Time-course of plasma peroxiredoxin-4 concentrations on day 2 of the exercise and control trials.
Superoxide dismutase 3 concentration
Time-course of plasma superoxide dismutase 3 concentrations on day 2 of the exercise and control trials.
Systolic and diastolic blood pressure
Time-course of systolic and diastolic blood pressure on day 2 of the exercise and control trials.

Full Information

First Posted
October 30, 2018
Last Updated
November 7, 2018
Sponsor
Loughborough University
Collaborators
University of Leicester, University Hospitals, Leicester
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1. Study Identification

Unique Protocol Identification Number
NCT03735186
Brief Title
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 4, 2017 (Actual)
Primary Completion Date
October 2, 2018 (Actual)
Study Completion Date
October 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loughborough University
Collaborators
University of Leicester, University Hospitals, Leicester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cigarette Smoking, Coronary Heart Disease, Cardiovascular Risk Factor, Insulin Resistance, Oxidative Stress, Inflammation
Keywords
Coronary heart disease, Exercise, Inflammation, Postprandial lipaemia, Smoking

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
60 min treadmill exercise performed at 60% of maximum oxygen uptake.
Primary Outcome Measure Information:
Title
Triacylglycerol concentration
Description
Total area under the plasma triacylglycerol concentration versus time curve on day 2
Time Frame
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 Outcome Measure Information:
Title
Glucose concentration
Description
Time-course of plasma glucose concentrations on day 2 of the exercise and control trials.
Time Frame
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)
Title
Insulin concentration
Description
Time-course of plasma insulin concentrations on day 2 of the exercise and control trials.
Time Frame
8 hours (Plasma samples will be collected at 0 (fasted), 0.5, 1, 3, 4, 4.5, 6, 8 hours)
Title
Homeostasis model assessment of insulin resistance (HOMA-IR)
Description
Homeostasis model assessment of insulin resistance (HOMA-IR) on day 2 of the exercise and control trials using fasting glucose and insulin concentrations.
Time Frame
Fasting (Plasma samples will be collected at 0 (fasted) hours)
Title
Non-esterified fatty acids concentration
Description
Time-course of plasma non-esterified fatty acid concentrations on day 2 of the exercise and control trials.
Time Frame
8 hours (Plasma samples will be collected at 0 (fasted), 0.5, 1, 3, 4, 4.5, 6, 8 hours)
Title
Total cholesterol concentration
Description
Circulating concentrations of plasma total cholesterol in the fasted state on day 2 of the exercise and control trials.
Time Frame
Fasting (Plasma samples will be collected at 0 (fasted) hours)
Title
High-density lipoprotein cholesterol concentration
Description
Circulating concentrations of plasma high-density lipoprotein cholesterol in the fasted state on day 2 of the exercise and control trials.
Time Frame
Fasting (Plasma samples will be collected at 0 (fasted) hours)
Title
Low-density lipoprotein cholesterol concentration
Description
Circulating concentrations of plasma low-density lipoprotein cholesterol in the fasted state on day 2 of the exercise and control trials.
Time Frame
Fasting (Plasma samples will be collected at 0 (fasted) hours)
Title
C-reactive protein concentration
Description
Time-course of plasma C-reactive protein concentrations on day 2 of the exercise and control trials.
Time Frame
8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
Title
Interleukin-6 concentration
Description
Time-course of plasma interleukin-6 concentrations on day 2 of the exercise and control trials.
Time Frame
8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
Title
Interleukin-10 concentration
Description
Time-course of plasma interleukin-10 concentrations on day 2 of the exercise and control trials.
Time Frame
8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
Title
Tumor necrosis factor alpha concentration
Description
Time-course of plasma tumor necrosis factor alpha concentrations on day 2 of the exercise and control trials.
Time Frame
8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
Title
Peroxiredoxin-4 concentration
Description
Time-course of plasma peroxiredoxin-4 concentrations on day 2 of the exercise and control trials.
Time Frame
8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
Title
Superoxide dismutase 3 concentration
Description
Time-course of plasma superoxide dismutase 3 concentrations on day 2 of the exercise and control trials.
Time Frame
8 hours (Plasma samples will be collected at 0 (fasted), 2, 5, 8 hours)
Title
Systolic and diastolic blood pressure
Description
Time-course of systolic and diastolic blood pressure on day 2 of the exercise and control trials.
Time Frame
8 hours (Blood pressure will be measured at 0 (fasted), 1, 2, 3, 4, 5, 6, 7, 8 hours)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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): 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Stensel
Organizational Affiliation
Loughborough University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tareq Alotaibi
Organizational Affiliation
Loughborough University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loughborough University
City
Loughborough
State/Province
Leicestershire
ZIP/Postal Code
LE11 3TU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26438068
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.
Results Reference
background
PubMed Identifier
23470315
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.
Results Reference
background
PubMed Identifier
18996856
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.
Results Reference
background
PubMed Identifier
33196606
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.
Results Reference
derived

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

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