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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • 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

    Recruiting

Other trials in United Kingdom

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 groups in NCT04720950
Study groupRoleWhat they receive
Morning exerciseExperimental1 hour of exercise completed between 0800-1000
Receives: Other: Exercise
Evening exerciseExperimental1 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.

  1. Total energy intake

    Covertly weighed food intake (kJ/day)

    Measured: Over 48 hours

Secondary outcomes (6)
  1. Distribution of energy intake across the day

    Covertly weighed food intake (kJ/eating epochs)

    Measured: Over 48 hours

  2. Percentage energy intake from macronutrients

    % energy intake from fat, total carbohydrates, sugar, protein and fibre

    Measured: Over 48 hours

  3. Basal metabolic rate

    By indirect calorimetry

    Measured: Over 8 minutes after waking

  4. Ambulatory blood pressure

    Measured using Spacelabs 90217 ambulatory monitors

    Measured: Over 24 hours

  5. Exercise induced feelings state.

    Measured using The Exercise Induced Feeling Inventory (EFI)

    Measured: Change over 1 hour (pre exercise to post exercise)

  6. 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.

  1. First posted22 Jan 2021
  2. Study start1 Dec 2020
  3. Primary completion31 May 2021 (estimated)
  4. Study completion31 May 2021 (estimated)

Resources

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)
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

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.

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