NCT02157233

Brief Summary

The potential of physical activity and other non-medicinal methods for the care and prevention of metabolic and cardiovascular disorders has been insufficiently used. There is a potential influence of environmental heat in energetic balance regulation. However, the existing knowledge is insufficient to optimize physical activity programs based on the impact of exercise on energy intake regulation in hot climates. The aim of the present study is to define the major physiological determinants of short-term food intake regulation in young active and healthy men, when exposed to different levels of metabolic activity and environmental temperatures. We will thus explore the biological mechanisms related to post-exercise relative energy intake. Post-rest and post-exercise energetic compensation will be analysed in these different environmental conditions, with a special focus on the effect of the birth weight. This study should open interesting ways to define adequate nutritional and exercising programs in hot environments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

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

Study Start

First participant enrolled

October 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 16, 2015

Status Verified

February 1, 2015

Enrollment Period

1.3 years

First QC Date

June 2, 2014

Last Update Submit

February 12, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Relative post-exercise and post-rest energy intake

    11 months

Secondary Outcomes (8)

  • Appetite hormones

    13 months

  • Heart rate variability

    11 months

  • Tympanic temperature

    11 months

  • Peak exercise capacity

    11 months

  • Appetite visual analogic scale

    11 months

  • +3 more secondary outcomes

Study Arms (2)

Hot environment

EXPERIMENTAL

Subjects will perform the intervention in a hot environment (33°C)

Behavioral: RestBehavioral: Exercise

Neutral environment

SHAM COMPARATOR

Subjects will perform the intervention in a neutral environment (22°C)

Behavioral: RestBehavioral: Exercise

Interventions

RestBEHAVIORAL
Hot environmentNeutral environment
ExerciseBEHAVIORAL
Hot environmentNeutral environment

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy and physically active men aged 18-30 years

You may not qualify if:

  • any physical or medical problem liable to limit the subjects' ability to perform the exercise testing in safe conditions,
  • ear troubles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CREPS

Les Abymes, Guadeloupe, France

Location

Related Publications (1)

  • Faure C, Charlot K, Henri S, Hardy-Dessources MD, Hue O, Antoine-Jonville S. Effect of heat exposure and exercise on food intake regulation: A randomized crossover study in young healthy men. Metabolism. 2016 Oct;65(10):1541-9. doi: 10.1016/j.metabol.2016.07.004. Epub 2016 Jul 11.

MeSH Terms

Interventions

RE1-silencing transcription factorExercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2014

First Posted

June 5, 2014

Study Start

October 1, 2013

Primary Completion

January 1, 2015

Study Completion

February 1, 2015

Last Updated

February 16, 2015

Record last verified: 2015-02

Locations