Loughborough University
Loughborough, United Kingdom
NCT Number: NCT05022498
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.
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Notify Me18 year–45 year
Male
Interventional
Not applicable
Loughborough, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
60 min treadmill exercise performed at 60% of maximum oxygen uptake.
Time frame: 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
Fasted plasma triacylglycerol concentration on day 1 and day 2. Time-averaged total area under the curve for triacylglycerol on day 2 in response to exercise and/or feeding.
Time frame: 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
Fasted plasma glucose concentration on day 1 and day 2. Time-averaged total area under the curve for glucose on day 2 in response to exercise and/or feeding.
Time frame: 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
Fasted plasma insulin concentration on day 1 and day 2. Time-averaged total area under the curve for insulin on day 2 in response to exercise and/or feeding.
Time frame: Day 1: fasted; Day 2: fasted
Fasted plasma total cholesterol concentration on day 1 and day 2.
Time frame: Day 1: fasted; Day 2: fasted
Fasted plasma high-density lipoprotein cholesterol concentration on day 1 and day 2.
Time frame: Day 1: fasted; Day 2: fasted
Fasted plasma low-density lipoprotein cholesterol concentration on day 1 and day 2.
Time frame: Day 1: fasted; Day 2: fasted
Fasted plasma C-reactive protein concentration on day 1 and day 2.
Time frame: Day 1: fasted (baseline)
Apolipoprotein E genotype at baseline.
Time frame: 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
Fasted resting systolic and diastolic blood pressure on day 1 and day 2. Time-averaged total area under the curve for systolic and diastolic blood pressure on day 2 in response to exercise and/or feeding.
Time frame: Day 1: fasted (0 hours), 8 hours; Day 2: fasted (0 hours), 2.5 hours, 5 hours.
Time-course of resting pulse wave analysis in response to exercise and/or feeding on day 1 and day 2.
Time frame: Day 1: fasted (0 hours), 8 hours; Day 2: fasted (0 hours), 2.5 hours, 5 hours.
Time-course of resting pulse wave velocity in response to exercise and/or feeding on day 1 and day 2.
Time frame: 20 nights (5 nights per condition; three nights before and two nights after visits 3, 5, 7 and 9)
Total time in bed between 'lights out' to 'lights on'.
Time frame: 20 nights (5 nights per condition; three nights before and two nights after visits 3, 5, 7 and 9)
Total time asleep between 'lights out' to 'lights on'.
Time frame: 20 nights (5 nights per condition; three nights before and two nights after visits 3, 5, 7 and 9)
Total time awake after the first sleep period.
Time frame: 20 nights (5 nights per condition; three nights before and two nights after visits 3, 5, 7 and 9)
Total time from 'lights out' to the first sleep epoch.
Time frame: 20 nights (5 nights per condition; three nights before and two nights after visits 3, 5, 7 and 9)
Total sleep time expressed as a percentage of time in bed.
Time frame: 20 nights (5 nights per condition; three nights before and two nights after visits 3, 5, 7 and 9)
Number of times that sleep is terminated after one minute expressed as a percentage of the total sleep time.
Loughborough University
Other
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
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