NCT05022498

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 20, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 26, 2021

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

1.8 years

First QC Date

August 20, 2021

Last Update Submit

August 16, 2022

Conditions

Coronary Heart DiseaseCardiovascular Risk FactorArterial StiffnessBlood PressureSleep

Outcome Measures

Primary Outcomes (1)

  • Plasma triacylglycerol concentration

    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.

    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 (16)

  • Plasma glucose concentration

    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

  • Plasma insulin concentration

    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

  • Plasma total cholesterol concentration

    Day 1: fasted; Day 2: fasted

  • Plasma high-density lipoprotein cholesterol concentration

    Day 1: fasted; Day 2: fasted

  • Plasma low-density lipoprotein cholesterol concentration

    Day 1: fasted; Day 2: fasted

  • +11 more secondary outcomes

Study Arms (4)

Control 1

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.

Control 2

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 1

EXPERIMENTAL

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.

Behavioral: Exercise

Exercise 2

EXPERIMENTAL

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.

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

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

Exercise 1Exercise 2

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loughborough University

Loughborough, United Kingdom

Location

Related Publications (10)

  • Freese EC, Gist NH, Cureton KJ. Effect of prior exercise on postprandial lipemia: an updated quantitative review. J Appl Physiol (1985). 2014 Jan 1;116(1):67-75. doi: 10.1152/japplphysiol.00623.2013. Epub 2013 Nov 7.

    PMID: 24201708BACKGROUND

  • Ashor AW, Lara J, Siervo M, Celis-Morales C, Mathers JC. Effects of exercise modalities on arterial stiffness and wave reflection: a systematic review and meta-analysis of randomized controlled trials. PLoS One. 2014 Oct 15;9(10):e110034. doi: 10.1371/journal.pone.0110034. eCollection 2014.

    PMID: 25333969BACKGROUND

  • Kredlow MA, Capozzoli MC, Hearon BA, Calkins AW, Otto MW. The effects of physical activity on sleep: a meta-analytic review. J Behav Med. 2015 Jun;38(3):427-49. doi: 10.1007/s10865-015-9617-6. Epub 2015 Jan 18.

    PMID: 25596964BACKGROUND

  • Goltz FR, Thackray AE, King JA, Dorling JL, Atkinson G, Stensel DJ. Interindividual Responses of Appetite to Acute Exercise: A Replicated Crossover Study. Med Sci Sports Exerc. 2018 Apr;50(4):758-768. doi: 10.1249/MSS.0000000000001504.

    PMID: 29240652BACKGROUND

  • Goltz FR, Thackray AE, Atkinson G, Lolli L, King JA, Dorling JL, Dowejko M, Mastana S, Stensel DJ. True Interindividual Variability Exists in Postprandial Appetite Responses in Healthy Men But Is Not Moderated by the FTO Genotype. J Nutr. 2019 Jul 1;149(7):1159-1169. doi: 10.1093/jn/nxz062.

    PMID: 31132105BACKGROUND

  • Atkinson G, Batterham AM. True and false interindividual differences in the physiological response to an intervention. Exp Physiol. 2015 Jun;100(6):577-88. doi: 10.1113/EP085070. Epub 2015 May 13.

    PMID: 25823596BACKGROUND

  • Senn S, Rolfe K, Julious SA. Investigating variability in patient response to treatment--a case study from a replicate cross-over study. Stat Methods Med Res. 2011 Dec;20(6):657-66. doi: 10.1177/0962280210379174. Epub 2010 Aug 25.

    PMID: 20739334BACKGROUND

  • Senn S. Mastering variation: variance components and personalised medicine. Stat Med. 2016 Mar 30;35(7):966-77. doi: 10.1002/sim.6739. Epub 2015 Sep 28.

    PMID: 26415869BACKGROUND

  • 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.

    PMID: 39446630DERIVED

  • 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.

    PMID: 37703030DERIVED

MeSH Terms

Conditions

Coronary Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • David Stensel

    Loughborough University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 20, 2021

First Posted

August 26, 2021

Study Start

October 1, 2019

Primary Completion

July 13, 2021

Study Completion

July 13, 2021

Last Updated

August 17, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

Anonymised individual participant data for all primary and secondary outcome measures will be made available upon request.

Locations

GB(1)