NCT05030636

Brief Summary

The main objective of this research project is to assess the impact of the timing of exercise on sensory perception, more specifically on taste and smell. Also, the investigators want to identify the optimal exercise timing scenario that maximizes the short-term anorexigenic effect of exercise (i.e. decrease in energy intake at the meal following the exercise session) in each group of teenagers. Hypothesis: exercise immediately before a meal (EX-\>MEAL) will be the most efficient scenario, and will show a larger impact on males individuals and people who suffer obesity. Subsequently, the investigators want to understand the impacts of exercise on lifestyle habits (i.e. sleep and sedentariness). For the realization of this research project, the investigators plan to recruit approximately 144 participants, boys and girls with normal weight/obesity, aged 12 to 17 years. Of these participants, half will be male. There are two different exercise timings (i.e. performed at 9:30 am and 11:00 am using a treadmill to test the maximal aerobic capacity) and one sedentary control condition. Participants will take part in 3 experimental visits in a random order (\~5 hours/visit at LAPS-UdeM + 24h of real-life monitoring). Appetite sensations, energy intake (i.e. total and macronutrient), activity monitoring using actigraphy, hormonal (i.e. anorexigenic and orexigenic) and chemosensory (i.e. cortical response to taste and smell stimulations) response will be monitored in the laboratory and/or remotely. This project will measure acute response in laboratory and real-life settings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 20, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

September 15, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

3.6 years

First QC Date

March 20, 2021

Last Update Submit

May 20, 2026

Conditions

Keywords

TeenagersExerciseNutritionAppetite

Outcome Measures

Primary Outcomes (5)

  • Energy intake at lunch

    Obtained using an ad libitum meal

    30 minutes

  • Physical activity habits outside the laboratory

    Time spent in moderate-to-vigorous intensity.

    24 hours

  • Eating habits outside the laboratory

    Ambulatory monitoring of food provided that is eaten (kcal total)

    24 hours

  • Sedentary activity habits outside the laboratory

    Time spent in sedentary activities

    24 hours

  • Sleep activity habits outside the laboratory

    Time spent sleeping at night

    24 hours

Secondary Outcomes (6)

  • Chemosensory response - Taste

    Within the 30 minutes devoted to chemosensory testing, prior to the meal at noon.

  • Circulating concentration of PYY

    Within the 30 minutes devoted to chemosensory testing, prior to the meal at noon.

  • Chemosensory response - Smell

    Within the 30 minutes devoted to chemosensory testing, prior to the meal at noon, and in the 2 hour period following meal.

  • Circulating concentration of GLP1

    Within the 30 minutes devoted to chemosensory testing, prior to the meal at noon, and in the 2 hour period following meal.

  • Circulating levels of ghrelin

    Within the 30 minutes devoted to chemosensory testing, prior to the meal at noon, and in the 2 hour period following meal.

  • +1 more secondary outcomes

Study Arms (3)

EX starts at 9:30 am

EXPERIMENTAL

A warm-up, 30 min at 70% VO2 max and a cool-down performed at 9:30 am.

Procedure: Acute moderate to vigorous exercise performed at a specific moment of the day

EX starts at 11:00 am

EXPERIMENTAL

A warm-up, 30 min at 70% VO2 max and a cool-down performed at 11:00 am.

Procedure: Acute moderate to vigorous exercise performed at a specific moment of the day

No EX

NO INTERVENTION

Control condition. A choice of 30 minutes sedentary activities.

Interventions

Treadmill (30 minutes) at 70% of maximal aerobic capacity

EX starts at 11:00 amEX starts at 9:30 am

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • must be 12-17 years old to ensure proper compliance with the study protocol and similar daily routines (i.e. attend high school);
  • have normal weight or obesity according to World Health Organisation criteria

You may not qualify if:

  • follow a specific diet or have food allergies;
  • have an eating disorder (e.g. anorexia or bulimia);
  • have a metabolic disease, are taking supplements or use medication that could influence the study results (e.g. insulin, lipid lowering drugs, corticosteroids);
  • are vegetarian or vegan, who cannot eat our validated meals which contain protein from animal sources;
  • have any intestinal disorders;
  • have physical limitations that restrict them from participating in our EX program;
  • are involved in competitive sports;
  • are not able to read or speak either French or English;
  • currently has COVID-19 or do not agree to respect sanitary measures during the visits; or,
  • smoke or use drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université de Montréal

Montreal, Quebec, H3C 3J7, Canada

Location

MeSH Terms

Conditions

Pediatric ObesityMotor Activity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Testing for each participant will comprise of 5 visits (1 preliminary and 4 experimental) conducted over a 5-8 week period at the LAPS-UdeM laboratory \[Laboratoire activité physique et santé (LAPS), Université de Montréal (UdeM), Montreal, Canada\]. Each participant will be assigned to the 3 different conditions in a random order. Each session will begin with 1 standard validated meal (breakfast) at 8:00 am, followed by 1 EX session (warm-up + 30 min @ 70% VO2 max + cool-down), performed at 9:30 am or 11:00 am, or no EX (30 min sedentary; Control).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Marie-Ève Mathieu, Principal investigator

Study Record Dates

First Submitted

March 20, 2021

First Posted

September 1, 2021

Study Start

September 15, 2021

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

May 26, 2026

Record last verified: 2026-05

Locations