ObesityNCT01036360
Acute Exercise and Energy Balance Regulation: Effect of Intensity
An observational study of Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Physical activity is mainly considered and use for its impact on energy expenditure in the treatment of obesity, and less is known concerning its indirect effects on energy intake. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- metabolic chamber
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2009to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: 20 adolescent boys (10 obese and 10 leans) and 20 men (10 obese and 10 lean
Who may be able to join
- Male
- Adults between 18 to 30 years old and adolescents between 12 and 15 years old
- Body mass index :
- lean adults : 20 <BMI< 25 kg.m²
- obese adults : 30<BMI<38 kg.m²
- lean adolescents: BMI <90th percentile
Show all 10Show fewer
- obese adolescents: BMI>97th percentile
- Affiliated to National Health Insurance
- Subject giving his written informed consent
- Subject considered as normal after clinical examination and medical questionnaire.
Who cannot join
- Chronic pathologies : cardiovascular diseases, cancer, chronic inflammation diseases, renal, intestinal impairments
- Refusal to be registered on the National Volunteers Data file
- Being in exclusion on the National Volunteers Data file
- Practising intensive physical exercise
- Heavy consumer of alcohol or/and tobacco
- Previous medical and/or surgery judged by the investigator as incompatible with this study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63000
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
About this study
Official title: Regulation of the Energy Balance Following an Acute Exercise in Metabolic Chambers: Effect of the Exercise Intensity, Age and Weight Status
Physical activity is mainly considered and use for its impact on energy expenditure in the treatment of obesity, and less is known concerning its indirect effects on energy intake. The aim of this work is to clarify the impact of an acute bout of exercise, depending on its intensity (high versus low), on the following energy intake and nutrient utilization, in obese and non-obese boys and men.
Read the detailed description
20 adolescent boys (10 obese and 10 leans) and 20 men (10 obese and 10 lean) will complete a sub-maximal test on a ergo cycle to draw their linear relationship between VO2 and Fc. Then they will enter a metabolic chamber three times, for 24 hours each. A first session will be considered as sedentary, and volunteers will remain inactive. During the second and third session, they will have to complete a cycling test generating an energy expenditure of 400 Kcal, once at low intensity (40%VO2max) and once at high intensity (70% VO2max). Those three sessions will be realized in a randomized order with an interval of at least 7 days and urinary collection over the 24hours will be done during all the sessions. At the beginning of the protocol, blood samples will be taken, body composition assessed by DXA and adiposity location evaluated by MNR.
- Conditions
- Obesity
- Being tested
- metabolic chamber
- Keywords
- Obesity, Acute exercise, Intensity of exercise, Energy balance regulation, Appetite
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metabolic chamberOther
20 adolescent boys (10 obese and 10 leans) and 20 men (10 obese and 10 lean) will complete a sub-maximal test on a ergo cycle to draw their linear relationship between VO2 and Fc. Then they will enter a metabolic chamber three times, for 24 hours each
| Study group | Role | What they receive |
|---|---|---|
| physical activity | Not described Receives: Other: metabolic chamber |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of energy intake over the 24 hours is the primary outcome. It will be assessed during the 3 experimental conditions: sedentary, low intensive exercise, high intensive exercise
Measured: over the 24 hours
Secondary outcomes (1)
Appetite feeling and substrate utilization are the two second outcomes. It will be assessed during the 3 experimental conditions: sedentary, low intensive exercise, high intensive exercise
Measured: with an interval of at least 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Regional Program for Clinical Research 2009 (PHRC 2009), Thermal Institution of Brides les Bains (FRANCE)
- Investigators
- Corinne BOUTELOUP, Principal investigator, CHU Clermont-Ferrand (CRNH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01036360
- Sponsor's protocol ID
- CHU-0063
- Status last verified
- Jan 2011
- First submitted
- 18 Dec 2009
- Last updated
- 19 Jan 2011
- Results posted
- No
Publications
Aucouturier J, Thivel D, Isacco L, Fellmann N, Chardigny JM, Duclos M, Duche P. Combined food intake and exercise unmask different hormonal responses in lean and obese children. Appl Physiol Nutr Metab. 2013 Jun;38(6):638-43. doi: 10.1139/apnm-2012-0246. Epub 2013 Jan 10.
PubMed 23724881Thivel D, Isacco L, Montaurier C, Boirie Y, Duche P, Morio B. The 24-h energy intake of obese adolescents is spontaneously reduced after intensive exercise: a randomized controlled trial in calorimetric chambers. PLoS One. 2012;7(1):e29840. doi: 10.1371/journal.pone.0029840. Epub 2012 Jan 17.
PubMed 22272251Thivel D, Isacco L, Taillardat M, Rousset S, Boirie Y, Morio B, Duche P. Gender effect on exercise-induced energy intake modification among obese adolescents. Appetite. 2011 Jun;56(3):658-61. doi: 10.1016/j.appet.2011.02.020. Epub 2011 Mar 2.
PubMed 21376093
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of the Energy Balance Following an Acute Exercise in Metabolic Chambers: Effect of the Exercise Intensity, Age and Weight Status
- ClinicalTrials.gov ID
- NCT01036360
- Acronym / sponsor ID
- CHU-0063
- Conditions
- Obesity
- Keywords
- Obesity, Acute exercise, Intensity of exercise, Energy balance regulation, Appetite
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Regional Program for Clinical Research 2009 (PHRC 2009), Thermal Institution of Brides les Bains (FRANCE)
- Study start
- Dec 2009
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 21 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Physical activity is mainly considered and use for its impact on energy expenditure in the treatment of obesity, and less is known concerning its indirect effects on energy intake. The aim of this work is to clarify the impact of an acute bout of exercise, depending on its intensity (high versus low), on the following energy intake and nutrient utilization, in obese and non-obese boys and men.
Detailed description
20 adolescent boys (10 obese and 10 leans) and 20 men (10 obese and 10 lean) will complete a sub-maximal test on a ergo cycle to draw their linear relationship between VO2 and Fc. Then they will enter a metabolic chamber three times, for 24 hours each. A first session will be considered as sedentary, and volunteers will remain inactive. During the second and third session, they will have to complete a cycling test generating an energy expenditure of 400 Kcal, once at low intensity (40%VO2max) and once at high intensity (70% VO2max). Those three sessions will be realized in a randomized order with an interval of at least 7 days and urinary collection over the 24hours will be done during all the sessions. At the beginning of the protocol, blood samples will be taken, body composition assessed by DXA and adiposity location evaluated by MNR.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| physical activity | – | Other: metabolic chamber |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 20 adolescent boys (10 obese and 10 leans) and 20 men (10 obese and 10 lean
Key inclusion criteria (10 listed)
- Male
- Adults between 18 to 30 years old and adolescents between 12 and 15 years old
- Body mass index :
- Affiliated to National Health Insurance
- Subject giving his written informed consent
Key exclusion criteria (6 listed)
- Chronic pathologies : cardiovascular diseases, cancer, chronic inflammation diseases, renal, intestinal impairments
- Refusal to be registered on the National Volunteers Data file
- Being in exclusion on the National Volunteers Data file
- Practising intensive physical exercise
- Heavy consumer of alcohol or/and tobacco
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metabolic chamber20 adolescent boys (10 obese and 10 leans) and 20 men (10 obese and 10 lean) will complete a sub-maximal test on a ergo cycle to draw their linear relationship between VO2 and Fc. Then they will enter a metabolic chamber three times, for 24 hours each | Other | physical activity |
Primary outcome
The amount of energy intake over the 24 hours is the primary outcome. It will be assessed during the 3 experimental conditions: sedentary, low intensive exercise, high intensive exercise
Time frame: over the 24 hours
1 secondary outcome
Appetite feeling and substrate utilization are the two second outcomes. It will be assessed during the 3 experimental conditions: sedentary, low intensive exercise, high intensive exercise
Time frame: with an interval of at least 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2011.
- Derived from this study: PubMed 23724881Aucouturier J, Thivel D, Isacco L, Fellmann N, Chardigny JM, Duclos M, Duche P. Combined food intake and exercise unmask different hormonal responses in lean and obese children. Appl Physiol Nutr Metab. 2013 Jun;38(6):638-43. doi: 10.1139/apnm-2012-0246. Epub 2013 Jan 10.
- Derived from this study: PubMed 22272251Thivel D, Isacco L, Montaurier C, Boirie Y, Duche P, Morio B. The 24-h energy intake of obese adolescents is spontaneously reduced after intensive exercise: a randomized controlled trial in calorimetric chambers. PLoS One. 2012;7(1):e29840. doi: 10.1371/journal.pone.0029840. Epub 2012 Jan 17.
- Derived from this study: PubMed 21376093Thivel D, Isacco L, Taillardat M, Rousset S, Boirie Y, Morio B, Duche P. Gender effect on exercise-induced energy intake modification among obese adolescents. Appetite. 2011 Jun;56(3):658-61. doi: 10.1016/j.appet.2011.02.020. Epub 2011 Mar 2.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinne BOUTELOUP principal investigator
CHU Clermont-Ferrand (CRNH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of energy intake over the 24 hours is the primary outcome. It will be assessed during the 3 experimental conditions: sedentary, low intensive exercise, high intensive exercise (time frame: over the 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01036360, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2011.