The Impact of Morning or Evening Exercise on Food Intake
TIME-Ex-Ulster
1 other identifier
interventional
12
1 country
1
Brief Summary
The beneficial effects of regular exercise on both physical and mental health are widely known; it is a pivotal component in the treatment and prevention of many metabolic disorders, including obesity. Exercise facilitates weight management, not only by increasing energy expenditure but through its effect on appetite regulation and, therefore, energy intake. Multiple factors influence the effect of exercise on appetite regulation including body fat , gender, intensity and duration of exercise and levels of habitual physical activity . However, recently interest has grown around the impact time-of-day of exercise may have on appetite regulation . Subjective feelings of hunger follow a strong diurnal pattern, with feelings of hunger peaking in the evening and appearing lowest in the morning . Evening energy intake has been associated with increased total energy intake and body mass index Evening exercise could potentially counteract or lessen the evening hunger sensations and therefore reduce evening and total energy intake. The aim of this study is to investigate any changes in total energy intake, distribution of energy intake, and food preference on the day of and 24 -hours after a bout of moderate-intensity exercise completed in the morning or evening in a group of physically inactive adults. A total sample of 12 physically inactive adults aged 18-60 will be recruited on to the study. The study will take the form of a two-armed randomised controlled crossover trial consisting of two 48-hr overnight stays in the Human Intervention Studies Unit (HISU) at Ulster University, Coleraine, Northern Ireland. The participant information sheet will focus on the effect of morning and evening exercise on ambulatory blood pressure and exercise-induced feeling states to prevent the participants' knowledge of the true purpose of the study from influencing their feeding behaviours. Ambulatory blood pressure will be monitored for at least 24 hours after the exercise session and participants will be asked to complete questionnaires of exercise induced feeling states immediately before and after each exercise session. Participants will be briefed on the true purpose of the study following the study completion. During the visits, participants will be asked to perform 1 hour of exercise at 70% of their maximal heart rate on a motorised treadmill between either 0800-1000 or 1800-2000 on the first full day of the study appointment. Food will be provided ad libitum for the duration of the study. All food intake will be noted and covertly weighed and directly observed through security cameras in the HISU dining room and lounge areas to measure food-related behaviours, such as grazing or bingeing. A 24 hour dietary recall will be conducted at the end of each study appointment to validate recall against observed intake.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Dec 2020
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2020
CompletedFirst Submitted
Initial submission to the registry
January 12, 2021
CompletedFirst Posted
Study publicly available on registry
January 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2021
CompletedJanuary 22, 2021
January 1, 2021
6 months
January 12, 2021
January 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total energy intake
Covertly weighed food intake (kJ/day)
Over 48 hours
Secondary Outcomes (6)
Distribution of energy intake across the day
Over 48 hours
Percentage energy intake from macronutrients
Over 48 hours
Basal metabolic rate
Over 8 minutes after waking
Ambulatory blood pressure
Over 24 hours
Exercise induced feelings state.
Change over 1 hour (pre exercise to post exercise)
- +1 more secondary outcomes
Study Arms (2)
Morning exercise
EXPERIMENTAL1 hour of exercise completed between 0800-1000
Evening exercise
EXPERIMENTAL1 hour of exercise completed between 1800-2000
Interventions
1 hour of exercise on a motorised treadmill at 70% maximal heart rate
Eligibility Criteria
You may qualify if:
- Does not exercise regularly (as determined by International Physical Activity Questionnaire (IPAQ) short form.
- Able to perform 1 hour of moderate-intensity exercise on a treadmill.
You may not qualify if:
- Pregnancy/ lactation.
- Have significant dysphagia, gastric outlet obstruction, or any other factor which prevents the consumption of a meal.
- Have a significant food allergy or dietary restriction.
- Have a systemic or gastrointestinal condition that may affect food intake or preference.
- Taking medication or supplements that affect energy intake or appetite.
- Taking medication that affects blood pressure or heart rate.
- Have an irregular sleep or shift work patterns.
- Travel across \> one time zone in the last month.
- Fitted with pacemaker
- Smokes or uses vaping products
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Human Intervention Studies Unit
Coleraine, N.Ireland, BT52 1SA, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- True purpose of the study is blinded to participants.
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2021
First Posted
January 22, 2021
Study Start
December 1, 2020
Primary Completion
May 31, 2021
Study Completion
May 31, 2021
Last Updated
January 22, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share