ObesityTIME-Ex-UlsterNCT04720950
The Impact of Morning or Evening Exercise on Food Intake
A study testing Exercise in people with Obesity, run by University of Ulster at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2020to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Human Intervention Studies Unit
Coleraine, N.Ireland, BT52 1SA
Ruth K Price, +442870123878, rk.price@ulster.ac.uk
Julie J Sittlington, +442870124101, jj.sittlington@ulster.ac.uk
About this study
Official title: The Impact of Morning or Evening Exercise on Total Energy Intake and Food Preference in Non-Exercising Adults.
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.
- Conditions
- Obesity
- Being tested
- Exercise
- Keywords
- Energy intake, Time of day, Exercise, Circadian rhythms, Food preferences
- Medical subject headings
- Obesity, Motor Activity, Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
1 hour of exercise on a motorised treadmill at 70% maximal heart rate
| Study group | Role | What they receive |
|---|---|---|
| Morning exercise | Experimental | 1 hour of exercise completed between 0800-1000 Receives: Other: Exercise |
| Evening exercise | Experimental | 1 hour of exercise completed between 1800-2000 Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total energy intake
Covertly weighed food intake (kJ/day)
Measured: Over 48 hours
Secondary outcomes (6)
Distribution of energy intake across the day
Covertly weighed food intake (kJ/eating epochs)
Measured: Over 48 hours
Percentage energy intake from macronutrients
% energy intake from fat, total carbohydrates, sugar, protein and fibre
Measured: Over 48 hours
Basal metabolic rate
By indirect calorimetry
Measured: Over 8 minutes after waking
Ambulatory blood pressure
Measured using Spacelabs 90217 ambulatory monitors
Measured: Over 24 hours
Exercise induced feelings state.
Measured using The Exercise Induced Feeling Inventory (EFI)
Measured: Change over 1 hour (pre exercise to post exercise)
Validation of 24 hour dietary recall against observed intake
Direct comparison between observed and reported food intake (kJ, % energy contribution from macronutrients)
Measured: Over 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Dec 2020
- Primary completion31 May 2021 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised crossover trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720950
- Sponsor's protocol ID
- FCBMS-20-061
- Acronym
- TIME-Ex-Ulster
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Morning or Evening Exercise on Total Energy Intake and Food Preference in Non-Exercising Adults.
- ClinicalTrials.gov ID
- NCT04720950
- Acronym / sponsor ID
- TIME-Ex-Ulster / FCBMS-20-061
- Conditions
- Obesity
- Keywords
- Energy intake, Time of day, Exercise, Circadian rhythms, Food preferences
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomised crossover trial
| Arm | Type | Receives |
|---|---|---|
| Morning exercise | Experimental | Other: Exercise1 hour of exercise completed between 0800-1000 |
| Evening exercise | Experimental | Other: Exercise1 hour of exercise completed between 1800-2000 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise1 hour of exercise on a motorised treadmill at 70% maximal heart rate | Other | Evening exercise, Morning exercise |
Primary outcome
Total energy intake
Time frame: Over 48 hours
Covertly weighed food intake (kJ/day)
6 secondary outcomes
Distribution of energy intake across the day
Time frame: Over 48 hours
Percentage energy intake from macronutrients
Time frame: Over 48 hours
Basal metabolic rate
Time frame: Over 8 minutes after waking
Ambulatory blood pressure
Time frame: Over 24 hours
Exercise induced feelings state.
Time frame: Change over 1 hour (pre exercise to post exercise)
Validation of 24 hour dietary recall against observed intake
Time frame: Over 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Obesity, run by University of Ulster at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alison M Gallagher (+44 28 7012 3178, am.gallagher@ulster.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total energy intake (time frame: Over 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.