- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04720950
The Impact of Morning or Evening Exercise on Food Intake (TIME-Ex-Ulster)
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.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
N.Ireland
-
Coleraine, N.Ireland, United Kingdom, BT52 1SA
- Recruiting
- Human Intervention Studies Unit
-
Contact:
- Ruth K Price
- Phone Number: +442870123878
- Email: rk.price@ulster.ac.uk
-
Contact:
- Julie J Sittlington
- Phone Number: +442870124101
- Email: jj.sittlington@ulster.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Morning exercise
1 hour of exercise completed between 0800-1000
|
1 hour of exercise on a motorised treadmill at 70% maximal heart rate
|
|
Experimental: Evening exercise
1 hour of exercise completed between 1800-2000
|
1 hour of exercise on a motorised treadmill at 70% maximal heart rate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total energy intake
Time Frame: Over 48 hours
|
Covertly weighed food intake (kJ/day)
|
Over 48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Distribution of energy intake across the day
Time Frame: Over 48 hours
|
Covertly weighed food intake (kJ/eating epochs)
|
Over 48 hours
|
|
Percentage energy intake from macronutrients
Time Frame: Over 48 hours
|
% energy intake from fat, total carbohydrates, sugar, protein and fibre
|
Over 48 hours
|
|
Basal metabolic rate
Time Frame: Over 8 minutes after waking
|
By indirect calorimetry
|
Over 8 minutes after waking
|
|
Ambulatory blood pressure
Time Frame: Over 24 hours
|
Measured using Spacelabs 90217 ambulatory monitors
|
Over 24 hours
|
|
Exercise induced feelings state.
Time Frame: Change over 1 hour (pre exercise to post exercise)
|
Measured using The Exercise Induced Feeling Inventory (EFI)
|
Change over 1 hour (pre exercise to post exercise)
|
|
Validation of 24 hour dietary recall against observed intake
Time Frame: Over 48 hours
|
Direct comparison between observed and reported food intake (kJ, % energy contribution from macronutrients)
|
Over 48 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FCBMS-20-061
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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