Clinical trial NCT05022498: Individual Variability of Coronary Heart Disease Risk Markers and Sleep Responses to Exercise
Official title: A Replicated Crossover Study Exploring Individual Variability of Postprandial Coronary Heart Disease Risk Markers and Sleep Quality in Response to Acute Exercise in Healthy Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Cardiovascular Risk Factor
Arterial Stiffness
Blood Pressure
Sleep
Lead sponsor: Loughborough University
Sponsor class: OTHER
Collaborators: name: Teesside University
First posted: 2021-08-26
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Plasma triacylglycerol concentration
timeFrame: Day 1: fasted; Day 2: fasted (0 hours), 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 7 hours and 8 hours
Secondary outcomes:
measure: Plasma glucose concentration
timeFrame: Day 1: fasted; Day 2: fasted (0 hours), 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 7 hours and 8 hours
measure: Plasma insulin concentration
timeFrame: Day 1: fasted; Day 2: fasted (0 hours), 0.5 hours, 1 hours, 2 hours, 3 hours, 4 hours, 4.5 hours, 5 hours, 6 hours, 7 hours and 8 hours
measure: Plasma total cholesterol concentration
timeFrame: Day 1: fasted; Day 2: fasted
measure: Plasma high-density lipoprotein cholesterol concentration
timeFrame: Day 1: fasted; Day 2: fasted
measure: Plasma low-density lipoprotein cholesterol concentration
timeFrame: Day 1: fasted; Day 2: fasted
measure: Plasma C-reactive protein concentration
timeFrame: Day 1: fasted; Day 2: fasted
measure: Apolipoprotein E
timeFrame: Day 1: fasted (baseline)
measure: Resting arterial blood pressure
timeFrame: Day 1: fasted; Day 2: fasted (0 hours), 1 hours, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours and 8 hours
measure: Resting pulse wave analysis
timeFrame: Day 1: fasted (0 hours), 8 hours; Day 2: fasted (0 hours), 2.5 hours, 5 hours.
measure: Resting pulse wave velocity
timeFrame: Day 1: fasted (0 hours), 8 hours; Day 2: fasted (0 hours), 2.5 hours, 5 hours.
measure: Time in bed
timeFrame: 20 nights (5 nights per condition; three nights before and two nights after visits 3, 5, 7 and 9)
measure: Total sleep time
timeFrame: 20 nights (5 nights per condition; three nights before and two nights after visits 3, 5, 7 and 9)
measure: Actual wake time
timeFrame: 20 nights (5 nights per condition; three nights before and two nights after visits 3, 5, 7 and 9)
measure: Sleep onset latency
timeFrame: 20 nights (5 nights per condition; three nights before and two nights after visits 3, 5, 7 and 9)
measure: Sleep efficiency
timeFrame: 20 nights (5 nights per condition; three nights before and two nights after visits 3, 5, 7 and 9)
measure: Sleep fragmentation index
timeFrame: 20 nights (5 nights per condition; three nights before and two nights after visits 3, 5, 7 and 9)
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: Loughborough University
Study officials:
affiliation: Loughborough University
name: David Stensel
role: PRINCIPAL_INVESTIGATOR
References:
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