NCT04720950

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

January 12, 2021

Last Update Submit

January 21, 2021

Conditions

Keywords

Energy intakeTime of dayExerciseCircadian rhythmsFood preferences

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

EXPERIMENTAL

1 hour of exercise completed between 0800-1000

Other: Exercise

Evening exercise

EXPERIMENTAL

1 hour of exercise completed between 1800-2000

Other: Exercise

Interventions

1 hour of exercise on a motorised treadmill at 70% maximal heart rate

Evening exerciseMorning exercise

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

RECRUITING

MeSH Terms

Conditions

ObesityMotor ActivityFood Preferences

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorFeeding Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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
Model Details: Randomised crossover trial
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

Locations