ObesityMONANCT02161926
Assessments of Dietary Restrictions in Young and Elderly Obese Men : Metabolism Obesity Nutrition Age
A study testing dietary restrictions in people with Obesity, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The prevalence of obesity is growing in elderly with heavy consequences in term of medical complications and mortality, so that this is nowadays an important public health issue. The major therapeutic solution is dietary restrictions, but and the advantages and the metabolic consequences are not well known in elderly. Read more about this study
- Who is it for?
- Ages 30 to 70 years, men only
- Conditions the study is for
- Obesity
- What is being tested?
- dietary restrictions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Feb 2017
- Phase
- Interventional
- 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 30 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 30 < years old < 40 OR 60 < years old < 70
- obesity : 30 < BMI < 40
- stable blood pressure (diastolic <90mmHg, systolic < 140mmHg)
- glycemia < 1,26g/L, LDL cholest <1,9-1,6g/L, Triglycerides <2,5g/L
- risk factors concerning high blood pressure, diabetes and dyslipidemia under control
Who cannot join
- Insulin dependent diabetes, non-insulin dependent diabetes
- high blood pressure
- dyslipidemia
- history of cardiovascular diseases or bariatric surgery
- undernutrition
- HbA1C >7%
- non authorized treatments : Glucagon-like peptide-1 agonists,
- incapacity to do physical activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Restrictions Implications on Metabolic Changes in Obese Men : Comparison Between Two Groups of Different Ages (60-70 Years Old Versus 30-40 Years Old)
The prevalence of obesity is growing in elderly with heavy consequences in term of medical complications and mortality, so that this is nowadays an important public health issue.
The major therapeutic solution is dietary restrictions, but and the advantages and the metabolic consequences are not well known in elderly. The MONA study main aim is to assess the metabolic changes in this population, after dietary restrictions, compared to young people.
Read the detailed description
Primary endpoint : Study the metabolic adaptations of the subcutaneous adipose tissue after a diet in elderly obese men compared to young obese men.
Secondary endpoints : Study the metabolic adaptations of skeletal muscle, the genetic adaptations of subcutaneous adipose tissue and skeletal muscle, the inflammatory and fibrosis modifications of subcutaneous adipose tissue, the insulinosensibility modifications, the modifications on the physical composition, modifications of the energy expenditure in resting state and the oxidation of the substrata, study the lipoproteins metabolism and identify new biomarkers. All those endpoints are studied comparing elderly obese subjects versus young obese subjects.
- Conditions
- Obesity
- Being tested
- dietary restrictions
- Keywords
- Obesity, dietary restrictions, metabolism, nutrition, elderly
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary restrictionsOther
Also called Dietary restrictions (20 % dietary restrictions)
Dietary restrictions during 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| obese men from 60 to 70 years old | Experimental | Dietary restrictions in obese men (30<Body Mass Index<40 kg/m2) Receives: Other: dietary restrictions |
| obese men from 30 to 40 years old | Active comparator | Dietary restrictions in obese men (30<Body Mass Index<40 kg/m2) Receives: Other: dietary restrictions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipolysis at resting and during physical activity test
Determine lipolysis at resting and during physical activity test by microdialysis, before dietary restrictions and after dietary restrictions (20% dietary restrictions)
Measured: Change after 8 weeks dietary restrictions
Secondary outcomes (8)
Metabolic parameters in skeletal muscle
To assess metabolic parameters before dietary restrictions and after dietary restrictions (20 % dietary restrictions)
Measured: Change after 8 weeks dietary restrictions
Genetic markers
To assess genetic markers in adipose tissue and skeletal tissue before dietary restrictions and after dietary restrictions
Measured: Change after 8 weeks dietary restrictions
Fibrosis and inflammatory markers in adipose tissue
To assess markers in adipose tissue before dietary restrictions and after dietary restrictions (20 % dietary restrictions)
Measured: Change after 8 weeks dietary restrictions
insulinosensibility
To determine insulinosensibility before dietary restrictions and after dietary restrictions (20 % dietary restrictions)
Measured: Change after 8 weeks dietary restrictions
Fat and muscles rates in the whole body
To determine fat and muscles rates by Dexa before dietary restrictions and after dietary restrictions
Measured: Change after 8 weeks dietary restrictions
Energetic consumption
energetic consumption at resting and during physical activity, before dietary restrictions and after dietary restrictions
Measured: Change after 8 weeks dietary restrictions
Lipoproteins metabolism
Before dietary restrictions and after dietary restrictions
Measured: Change after 8 weeks dietary restrictions
biomarkers identification
New urinary and intestinal biomarkers identification, before dietary restrictions and after dietary restrictions
Measured: Change after 8 weeks dietary restrictions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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, ToulouseThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Thalamas, MD PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161926
- Sponsor's protocol ID
- 13 149 03
- Other IDs
- 2013-A01543-42
- Acronym
- MONA
- Status last verified
- Apr 2026
- First submitted
- 6 Jun 2014
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vion J, Sramkova V, Montastier E, Marques MA, Caspar-Bauguil S, Duparc T, Martinez LO, Bourlier V, Harant I, Larrouy D, Moussaoui N, Bonnel S, Vindis C, Dray C, Valet P, Saulnier-Blache JS, Schanstra JP, Thalamas C, Viguerie N, Moro C, Langin D. Metabolic and cardiovascular adaptations to an 8-wk lifestyle weight loss intervention in younger and older obese men. Am J Physiol Endocrinol Metab. 2021 Sep 1;321(3):E325-E337. doi: 10.1152/ajpendo.00109.2021. Epub 2021 Jul 12.
PubMed 34250814Laurens C, Parmar A, Murphy E, Carper D, Lair B, Maes P, Vion J, Boulet N, Fontaine C, Marques M, Larrouy D, Harant I, Thalamas C, Montastier E, Caspar-Bauguil S, Bourlier V, Tavernier G, Grolleau JL, Bouloumie A, Langin D, Viguerie N, Bertile F, Blanc S, de Glisezinski I, O'Gorman D, Moro C. Growth and differentiation factor 15 is secreted by skeletal muscle during exercise and promotes lipolysis in humans. JCI Insight. 2020 Mar 26;5(6):e131870. doi: 10.1172/jci.insight.131870.
PubMed 32106110
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Restrictions Implications on Metabolic Changes in Obese Men : Comparison Between Two Groups of Different Ages (60-70 Years Old Versus 30-40 Years Old)
- ClinicalTrials.gov ID
- NCT02161926
- Acronym / sponsor ID
- MONA / 13 149 03
- Conditions
- Obesity
- Keywords
- Obesity, dietary restrictions, metabolism, nutrition, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 12 Jun 2014 (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.
The prevalence of obesity is growing in elderly with heavy consequences in term of medical complications and mortality, so that this is nowadays an important public health issue.
The major therapeutic solution is dietary restrictions, but and the advantages and the metabolic consequences are not well known in elderly. The MONA study main aim is to assess the metabolic changes in this population, after dietary restrictions, compared to young people.
Detailed description
Primary endpoint : Study the metabolic adaptations of the subcutaneous adipose tissue after a diet in elderly obese men compared to young obese men.
Secondary endpoints : Study the metabolic adaptations of skeletal muscle, the genetic adaptations of subcutaneous adipose tissue and skeletal muscle, the inflammatory and fibrosis modifications of subcutaneous adipose tissue, the insulinosensibility modifications, the modifications on the physical composition, modifications of the energy expenditure in resting state and the oxidation of the substrata, study the lipoproteins metabolism and identify new biomarkers. All those endpoints are studied comparing elderly obese subjects versus young obese subjects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obese men from 60 to 70 years old | Experimental | Other: dietary restrictionsDietary restrictions in obese men (30<Body Mass Index<40 kg/m2) |
| obese men from 30 to 40 years old | Active comparator | Other: dietary restrictionsDietary restrictions in obese men (30<Body Mass Index<40 kg/m2) |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 30 < years old < 40 OR 60 < years old < 70
- obesity : 30 < BMI < 40
- stable blood pressure (diastolic <90mmHg, systolic < 140mmHg)
- glycemia < 1,26g/L, LDL cholest <1,9-1,6g/L, Triglycerides <2,5g/L
- risk factors concerning high blood pressure, diabetes and dyslipidemia under control
Key exclusion criteria (8 listed)
- Insulin dependent diabetes, non-insulin dependent diabetes
- high blood pressure
- dyslipidemia
- history of cardiovascular diseases or bariatric surgery
- undernutrition
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 |
|---|---|---|
| dietary restrictionsAlso: Dietary restrictions (20 % dietary restrictions)Dietary restrictions during 8 weeks | Other | obese men from 30 to 40 years old, obese men from 60 to 70 years old |
Primary outcome
Lipolysis at resting and during physical activity test
Time frame: Change after 8 weeks dietary restrictions
Determine lipolysis at resting and during physical activity test by microdialysis, before dietary restrictions and after dietary restrictions (20% dietary restrictions)
8 secondary outcomes
Metabolic parameters in skeletal muscle
Time frame: Change after 8 weeks dietary restrictions
Genetic markers
Time frame: Change after 8 weeks dietary restrictions
Fibrosis and inflammatory markers in adipose tissue
Time frame: Change after 8 weeks dietary restrictions
insulinosensibility
Time frame: Change after 8 weeks dietary restrictions
Fat and muscles rates in the whole body
Time frame: Change after 8 weeks dietary restrictions
Energetic consumption
Time frame: Change after 8 weeks dietary restrictions
Lipoproteins metabolism
Time frame: Change after 8 weeks dietary restrictions
biomarkers identification
Time frame: Change after 8 weeks dietary restrictions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Results publication: PubMed 34250814Vion J, Sramkova V, Montastier E, Marques MA, Caspar-Bauguil S, Duparc T, Martinez LO, Bourlier V, Harant I, Larrouy D, Moussaoui N, Bonnel S, Vindis C, Dray C, Valet P, Saulnier-Blache JS, Schanstra JP, Thalamas C, Viguerie N, Moro C, Langin D. Metabolic and cardiovascular adaptations to an 8-wk lifestyle weight loss intervention in younger and older obese men. Am J Physiol Endocrinol Metab. 2021 Sep 1;321(3):E325-E337. doi: 10.1152/ajpendo.00109.2021. Epub 2021 Jul 12.
- Results publication: PubMed 32106110Laurens C, Parmar A, Murphy E, Carper D, Lair B, Maes P, Vion J, Boulet N, Fontaine C, Marques M, Larrouy D, Harant I, Thalamas C, Montastier E, Caspar-Bauguil S, Bourlier V, Tavernier G, Grolleau JL, Bouloumie A, Langin D, Viguerie N, Bertile F, Blanc S, de Glisezinski I, O'Gorman D, Moro C. Growth and differentiation factor 15 is secreted by skeletal muscle during exercise and promotes lipolysis in humans. JCI Insight. 2020 Mar 26;5(6):e131870. doi: 10.1172/jci.insight.131870.
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.
Claire Thalamas, MD PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary restrictions in people with Obesity, run by University Hospital, Toulouse 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 9 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipolysis at resting and during physical activity test (time frame: Change after 8 weeks dietary restrictions). 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 NCT02161926, which also lists 2 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 9 Apr 2026.