Individual Variability of Coronary Heart Disease Risk Markers and Sleep Responses to Exercise

NCT ID: NCT05022498

Last Updated: 2022-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2021-07-13

Brief Summary

The aim of this study is to examine the reproducibility of postprandial coronary heart disease (CHD) risk marker and sleep responses to acute exercise bouts and to quantify the magnitude of individual variability in responses using a replicated crossover design. Healthy, recreationally active men will complete two identical rest control and two identical exercise (60 min at 60% maximum oxygen uptake) conditions in randomised sequences. Fasting and postprandial venous blood samples, arterial blood pressure and arterial stiffness measurements will be taken at pre-determined intervals, and sleep duration and quality will be assessed. Reproducibility and individual variability will be examined using bivariate correlations and linear mixed modelling.

Detailed Description

Single bouts of exercise reduce circulating concentrations of postprandial triacylglycerol - an established independent risk marker for coronary heart disease (CHD). The exercise-induced reduction in postprandial triacylglycerol concentrations has been shown to coincide with transient changes in other CHD risk markers, including reductions in postprandial insulin, interleukin-6, arterial stiffness and resting arterial blood pressure, and exercise may also promote sleep duration and quality. Individual variability in these responses is suspected but has not been examined using robust designs and appropriate statistical models. A recent approach to quantify individual variability in the intervention response involves quantifying the participant-by-condition interaction from replicated intervention and comparator arms. Using this approach (the replicated crossover design), the present study will (i) examine whether the postprandial CHD risk marker and sleep responses to acute exercise are reproducible on repeated occasions; and (ii) determine whether there is true individual variability in postprandial CHD risk marker and sleep responses to acute exercise.

A total of 20 healthy, recreationally active men will be recruited. Participants will undertake a preliminary measures visit (visit 1) to confirm eligibility, to undergo anthropometric measurements and to determine maximum oxygen uptake. Participants will complete four, 2-day experimental conditions in randomised sequences separated by at least one week: two identical control and two identical exercise conditions. On day 1 (visits 2, 4, 6 and 8), participants will arrive fasted at 08:00 and a baseline blood sample, blood pressure and arterial stiffness measurement will be taken. Participants will consume a standardised high fat breakfast at 08:45 (0 h) and lunch at 12:45 (4 h). A second arterial stiffness measurement will be taken at 16:45 (8 h). The two control and two exercise conditions will be identical, except that participants will be asked to exercise on the treadmill for 60 minutes at 60% of their maximum oxygen uptake at 15:15 (6.5 h) in both exercise conditions. On day 2 (visits 3, 5, 7 and 9), participants will arrive fasted at 08:00 and will rest in the laboratory throughout the day in the two control and two exercise conditions. Participants will consume a standardised breakfast at 08:45 (0 h) and a standardised lunch at 12:45 (4 h). Venous blood samples will be collected at 0, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 8 h. Resting arterial blood pressure will be measured at hourly intervals. Arterial stiffness will be measured at 0, 2.5 and 5 h. Sleep duration and quality will be assessed for three nights before and two nights after visits 3, 5, 7 and 9 using a triaxial actigraphy watch.

Reproducibility and individual variability will be explored by correlating the two sets of response differences between exercise and control conditions. Within-participant covariate-adjusted linear mixed models will be used to quantify participant-by-condition interactions. It is hypothesised that (i) control-adjusted postprandial CHD risk marker and sleep responses to acute exercise will be reproducible; and (ii) true interindividual variability will exist in postprandial CHD risk marker and sleep responses to acute exercise beyond any random within-subject variation.

Conditions

Coronary Heart Disease; Cardiovascular Risk Factor; Arterial Stiffness; Blood Pressure; Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Control 1

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Control 2

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Exercise 1

Participants will complete 60 min of treadmill exercise on day 1 (15:15-16:15). 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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

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

Exercise 2

Participants will complete 60 min of treadmill exercise on day 1 (15:15-16:15). 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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

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

Interventions

Exercise

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18 to 45-year-old men;
• Be able to run continuously for 1 hour;
• Body mass index between 18.5 and 29.9 kg/m2;
• No known contradictions to maximal exertion exercise (e.g., recent musculoskeletal injury, congenital heart disease).

Exclusion Criteria

• Musculoskeletal injury that has affected normal ambulation within the last month;
• Uncontrolled exercise-induced asthma;
• Coagulation or bleeding disorders;
• Heart conditions;
• Diabetes (metabolism will be different to non-diabetics potentially skewing the data);
• Taking any medication that might influence fat metabolism, blood glucose or appetite;
• Smoking (including vaping);
• Dieting or restrained eating behaviours;
• Weight fluctuation greater than 3 kg in the previous 3 months to study enrolment;
• Presence of any diagnosed sleeping disorder;
• A food allergy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Teesside University

OTHER

Sponsor Role: collaborator

Loughborough University

OTHER

Sponsor Role: lead

Responsible Party

Professor David Stensel

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Stensel

Role: PRINCIPAL_INVESTIGATOR

Loughborough University

Locations

Loughborough University

Loughborough, , United Kingdom

Countries

United Kingdom

References

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Yang Y, Thackray AE, Shen T, Alotaibi TF, Alanazi TM, Clifford T, Hartescu I, King JA, Roberts MJ, Willis SA, Lolli L, Atkinson G, Stensel DJ. A replicate crossover trial on the interindividual variability of sleep indices in response to acute exercise undertaken by healthy men. Sleep. 2025 Mar 11;48(3):zsae250. doi: 10.1093/sleep/zsae250.

Reference Type: DERIVED

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Shen T, Thackray AE, King JA, Alotaibi TF, Alanazi TM, Willis SA, Roberts MJ, Lolli L, Atkinson G, Stensel DJ. Are There Interindividual Responses of Cardiovascular Disease Risk Markers to Acute Exercise? A Replicate Crossover Trial. Med Sci Sports Exerc. 2024 Jan 1;56(1):63-72. doi: 10.1249/MSS.0000000000003283. Epub 2023 Aug 30.

Reference Type: DERIVED

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Other Identifiers

LU-R19-P103

Identifier Type: -

Identifier Source: org_study_id