The Impact of Morning or Evening Exercise on Food Intake

Obesity Clinical Trial

— TIME-Ex-Ulster  

Official title:

The Impact of Morning or Evening Exercise on Total Energy Intake and Food Preference in Non-Exercising Adults.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04720950
• Other study ID #: FCBMS-20-061
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: January 2021
• Source: University of Ulster
• Contact: Alison M Gallagher
• Phone: +44 28 7012 3178
• Email: am.gallagher[@]ulster.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Exercise
1 hour of exercise on a motorised treadmill at 70% maximal heart rate

Locations

Country	Name	City	State
United Kingdom	Human Intervention Studies Unit	Coleraine	N.Ireland

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulster

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total energy intake	Covertly weighed food intake (kJ/day)	Over 48 hours
Secondary	Distribution of energy intake across the day	Covertly weighed food intake (kJ/eating epochs)	Over 48 hours
Secondary	Percentage energy intake from macronutrients	% energy intake from fat, total carbohydrates, sugar, protein and fibre	Over 48 hours
Secondary	Basal metabolic rate	By indirect calorimetry	Over 8 minutes after waking
Secondary	Ambulatory blood pressure	Measured using Spacelabs 90217 ambulatory monitors	Over 24 hours
Secondary	Exercise induced feelings state.	Measured using The Exercise Induced Feeling Inventory (EFI)	Change over 1 hour (pre exercise to post exercise)
Secondary	Validation of 24 hour dietary recall against observed intake	Direct comparison between observed and reported food intake (kJ, % energy contribution from macronutrients)	Over 48 hours