ObesityOBEFITTNCT01326416
Evaluation of the Impact of Physical Reconditioning Associated With Specific Nutritional Supplementation in Obese Patients Suffering From Metabolic Syndrome
A study testing L-Leucine and L-arginine and Physical Reconditioning by a trainer in people with Obesity and Metabolic Syndrome, run by University Hospital, Rouen at 1 site in France.
Trial summary
Android obesity contributes, via insulin resistance and endothelial dysfunction, to the development of cardiovascular atherosclerosis. It leads to poor quality of life. It is often associated with metabolic syndrome which includes, whatever the definitions used (National Education Cholesterol Program, NECP / Adult… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Obesity, Metabolic Syndrome
- What is being tested?
- L-Leucine and L-arginine and Physical Reconditioning by a trainer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2011to Nov 2015
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Suffering from obesity (Body Mass Index (BMI) > 30kg.m-2) with a maximal weight of 135 kg
- Suffering from metabolic syndrome (International Federation of Diabetes(FID) definition)
- Hospitalized or followed in consultation
- Age 18 to 55 years old
- Not having recently participated in other clinical studies during the last days before pre-inclusion consultation
- Affiliated to a National Insurance scheme
- Having National Social Security insurance
Who cannot join
- Asthma, chronic respiratory failure, obstructive chronic bronchitis
- Current or recent Pneumothorax, recent pleural draining or biopsy, current hemoptysis, untreated / in course of treatment active tuberculosis
- Coronaropathy, myocardiopathy, myocarditis, unstable cardiac failure, ventricular rhythm disorders
- Severe Anemia
- Severe inferior members Arteritis
- Incapacity to walk or cycle
Show all 20Show fewer
- Severe renal failure (Creatinine Clearance <or = 30 mL/min)
- Severe Sepsis
- Psychiatric Disorders (Diagnostic and Statistical Manual - Revision 4 (DSM IV) criteria) such as schizophrenia, other psychoses or major depressive non treated syndromes
- Severe or non treated Eating Disorders implicated in obesity (compulsive access, bulimia)
- Patients under guardianship or with curators
- Women in age of procreation without means of effective contraception
- Pregnant or breast-feeding women
- Taking medicates such as: proteinate powder (Protifar ®, SP95 ®, Orlistat (Xenical ®, Ally ®), exenatide (Byetta ®), sitagliptin (Januvia ®, Xelevia ®), vildagliptin (Galvus ®), sitagliptin-metformin (Janumet ®), Vildagliptin-metformin (Eucreas ®), tadalafil (Cialis ®) sildenafil (Viagra ®)
- Drug addiction to opiates in the last six months
- Alcohol or drug abuse
- Infection by Human Immunodeficiency Virus (HIV) , viral hepatitis B and viral hepatitis C
- Active addiction to smoking in more than 8 cigarettes a day
- Understanding badly spoken or written French
- Performed, in 2 to 3 days preceding the Dual-energy X-Ray Absorptiometry (DEXA) exam, of a bone scintigraphy or a digestive tract radiological examination with the use of barium type of contrast agent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of Physical Reconditioning Associated With Specific Nutritional Supplementation in Obese Patients Suffering From Metabolic Syndrome. OBEFITT Study.
Android obesity contributes, via insulin resistance and endothelial dysfunction, to the development of cardiovascular atherosclerosis. It leads to poor quality of life. It is often associated with metabolic syndrome which includes, whatever the definitions used (National Education Cholesterol Program, NECP / Adult Treatment Panel III, ATP III or International Diabetes Federation, IDF), an increased waist measurement, an arterial high blood pressure and disorders of the glucide and lipid metabolism. The treatment of the current "epidemic" of obesity and metabolic syndrome in France (12.4 % of obese and 14 % of subjects with metabolic syndrome) thus requires new therapeutic approaches.
A well-balanced diet and a daily physical activity are the indispensable requirements for the treatment of obesity and metabolic syndrome. It is possible to associate it to pharmacological agents, but the results are often partial and transient. Preliminary data suggest that leucine or arginine supplementation could facilitate the loss of fat mass. Moreover, the physical exercise has also demonstrated benefits.
Sessions of physical reconditioning (aerobic work + muscular intensification) associated with a program of specific nutritional supplementation by a mixture of Leucine and Arginine (in the daytime) could improve the treatment of obese subjects affected by metabolic syndrome.
- Conditions
- Obesity, Metabolic Syndrome
- Being tested
- L-Leucine and L-arginine, Physical Reconditioning by a trainer
- Keywords
- obesity, metabolic syndrome, leucine, arginine, physical activity
- Medical subject headings
- Obesity, Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-Leucine and L-arginineDietary supplement
Specific nutritional supplementation for six months by 30g per day of a mixture of amino acids (21 g L-Leucine and 9 g of L-arginine), to be distributed during each of the 3 main meals.
Physical Reconditioning by a trainerOther
Physical reconditioning sessions begin with a warm-up for five minutes for the type of effort made, and then correspond to a sporting course composed of elements of strength training and / or aerobic exercises and will be completed by a return to simple stretching and general advice on managing their physical life. The duration of each session will be 45 minutes at the beginning of the protocol and then gradually increased over time to achieve 1:30 of total physical activity at the end of protocol.
| Study group | Role | What they receive |
|---|---|---|
| S: Nutritional Supplementation alone | Active comparator | Specific nutritional supplementation for six months by 30g per day of a mixture of amino acids (21 g of L-Leucine and 9 g of L-arginine), to distribute during each of the 3 main meals. Receives: Dietary Supplement: L-Leucine and L-arginine |
| A: Physical Reconditioning alone | Active comparator | Physical reconditioning sessions led by a trainer three times a week for 6 months. Receives: Other: Physical Reconditioning by a trainer |
| AS: Physical Reconditioning + Nutritional Supplementation | Active comparator | Association for six months of a specific nutritional supplementation by 21 g of L-Leucine and 9 g of L-arginine per day (to distribute during each of the 3 main meals) and of physical reconditioning sessions three times a week. |
| C: Lifestyle counseling | No intervention | Usual advice given in consultation on the need for a balanced diet and regular physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total body fat mass
Change in total body fat mass estimated by Dual-energy X-Ray Absorptiometry (DEXA).
Measured: 6 months
Secondary outcomes (1)
Weight
Change in weight, visceral fat mass, total lean mass, Bone Mineral Density, clinical and biological parameters of metabolic syndrome, insulin resistance, vascular inflammation parameters, heart rate variability, quadriceps strength, ventilatory parameters and quality of life score.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2015
- Study completionNov 2015
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, RouenThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanessa FOLOPE, M.D., Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326416
- Sponsor's protocol ID
- 2008/066/HP
- Other IDs
- 2009-009155-37, 2009
- Acronym
- OBEFITT
- Status last verified
- Apr 2026
- First submitted
- 29 Mar 2011
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Folope V, Meret C, Castres I, Tourny C, Houivet E, Grigioni S, Lelandais H, Petit A, Coquard A, Guerin C, Quillard M, Bole-Feysot C, Dechelotte P, Achamrah N, Coeffier M. Evaluation of a Supervised Adapted Physical Activity Program Associated or Not with Oral Supplementation with Arginine and Leucine in Subjects with Obesity and Metabolic Syndrome: A Randomized Controlled Trial. Nutrients. 2022 Sep 8;14(18):3708. doi: 10.3390/nu14183708.
PubMed 36145083Évaluation de l'effet d'un programme d'activité physique adaptée associé à une supplémentation en Leucine et en Arginine chez des sujets obèses présentant un syndrome métabolique : Protocole OBEFITT - 2018 - V. Folope Leborgne 1, ⁎ , C. Meret 1, E. Houivet 2, N. Achamrah 1, S. Grigioni 1, A. Rimbert 1, A. Petit 1, M. Coeffier 1, P. Déchelotte 1
Debeaumont D, Tardif C, Folope V, Castres I, Lemaitre F, Tourny C, Dechelotte P, Thill C, Darmon A, Coquart JB. A specific prediction equation is necessary to estimate peak oxygen uptake in obese patients with metabolic syndrome. J Endocrinol Invest. 2016 Jun;39(6):635-42. doi: 10.1007/s40618-015-0411-7. Epub 2015 Dec 22.
PubMed 26694707
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Physical Reconditioning Associated With Specific Nutritional Supplementation in Obese Patients Suffering From Metabolic Syndrome. OBEFITT Study.
- ClinicalTrials.gov ID
- NCT01326416
- Acronym / sponsor ID
- OBEFITT / 2008/066/HP
- Conditions
- Obesity, Metabolic Syndrome
- Keywords
- obesity, metabolic syndrome, leucine, arginine, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 30 Mar 2011 (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.
Android obesity contributes, via insulin resistance and endothelial dysfunction, to the development of cardiovascular atherosclerosis. It leads to poor quality of life. It is often associated with metabolic syndrome which includes, whatever the definitions used (National Education Cholesterol Program, NECP / Adult Treatment Panel III, ATP III or International Diabetes Federation, IDF), an increased waist measurement, an arterial high blood pressure and disorders of the glucide and lipid metabolism. The treatment of the current "epidemic" of obesity and metabolic syndrome in France (12.4 % of obese and 14 % of subjects with metabolic syndrome) thus requires new therapeutic approaches.
A well-balanced diet and a daily physical activity are the indispensable requirements for the treatment of obesity and metabolic syndrome. It is possible to associate it to pharmacological agents, but the results are often partial and transient. Preliminary data suggest that leucine or arginine supplementation could facilitate the loss of fat mass. Moreover, the physical exercise has also demonstrated benefits.
Sessions of physical reconditioning (aerobic work + muscular intensification) associated with a program of specific nutritional supplementation by a mixture of Leucine and Arginine (in the daytime) could improve the treatment of obese subjects affected by metabolic syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| S: Nutritional Supplementation alone | Active comparator | Dietary Supplement: L-Leucine and L-arginineSpecific nutritional supplementation for six months by 30g per day of a mixture of amino acids (21 g of L-Leucine and 9 g of L-arginine), to distribute during each of the 3 main meals. |
| A: Physical Reconditioning alone | Active comparator | Other: Physical Reconditioning by a trainerPhysical reconditioning sessions led by a trainer three times a week for 6 months. |
| AS: Physical Reconditioning + Nutritional Supplementation | Active comparator | –Association for six months of a specific nutritional supplementation by 21 g of L-Leucine and 9 g of L-arginine per day (to distribute during each of the 3 main meals) and of physical reconditioning sessions three times a week. |
| C: Lifestyle counseling | No intervention | –Usual advice given in consultation on the need for a balanced diet and regular physical activity |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Suffering from obesity (Body Mass Index (BMI) > 30kg.m-2) with a maximal weight of 135 kg
- Suffering from metabolic syndrome (International Federation of Diabetes(FID) definition)
- Hospitalized or followed in consultation
- Age 18 to 55 years old
- Not having recently participated in other clinical studies during the last days before pre-inclusion consultation
Key exclusion criteria (20 listed)
- Asthma, chronic respiratory failure, obstructive chronic bronchitis
- Current or recent Pneumothorax, recent pleural draining or biopsy, current hemoptysis, untreated / in course of treatment active tuberculosis
- Coronaropathy, myocardiopathy, myocarditis, unstable cardiac failure, ventricular rhythm disorders
- Severe Anemia
- Severe inferior members Arteritis
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 |
|---|---|---|
| L-Leucine and L-arginineSpecific nutritional supplementation for six months by 30g per day of a mixture of amino acids (21 g L-Leucine and 9 g of L-arginine), to be distributed during each of the 3 main meals. | Dietary supplement | S: Nutritional Supplementation alone |
| Physical Reconditioning by a trainerPhysical reconditioning sessions begin with a warm-up for five minutes for the type of effort made, and then correspond to a sporting course composed of elements of strength training and / or aerobic exercises and will be completed by a return to simple stretching and general advice on managing their physical life. The duration of each session will be 45 minutes at the beginning of the protocol and then gradually increased over time to achieve 1:30 of total physical activity at the end of protocol. | Other | A: Physical Reconditioning alone |
Primary outcome
Total body fat mass
Time frame: 6 months
Change in total body fat mass estimated by Dual-energy X-Ray Absorptiometry (DEXA).
1 secondary outcome
Weight
Time frame: 6 months
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 16 Apr 2026.
- Results publication: PubMed 36145083Folope V, Meret C, Castres I, Tourny C, Houivet E, Grigioni S, Lelandais H, Petit A, Coquard A, Guerin C, Quillard M, Bole-Feysot C, Dechelotte P, Achamrah N, Coeffier M. Evaluation of a Supervised Adapted Physical Activity Program Associated or Not with Oral Supplementation with Arginine and Leucine in Subjects with Obesity and Metabolic Syndrome: A Randomized Controlled Trial. Nutrients. 2022 Sep 8;14(18):3708. doi: 10.3390/nu14183708.
- Results publicationÉvaluation de l'effet d'un programme d'activité physique adaptée associé à une supplémentation en Leucine et en Arginine chez des sujets obèses présentant un syndrome métabolique : Protocole OBEFITT - 2018 - V. Folope Leborgne 1, ⁎ , C. Meret 1, E. Houivet 2, N. Achamrah 1, S. Grigioni 1, A. Rimbert 1, A. Petit 1, M. Coeffier 1, P. Déchelotte 1
- Results publication: PubMed 26694707Debeaumont D, Tardif C, Folope V, Castres I, Lemaitre F, Tourny C, Dechelotte P, Thill C, Darmon A, Coquart JB. A specific prediction equation is necessary to estimate peak oxygen uptake in obese patients with metabolic syndrome. J Endocrinol Invest. 2016 Jun;39(6):635-42. doi: 10.1007/s40618-015-0411-7. Epub 2015 Dec 22.
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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.
Vanessa FOLOPE, M.D. principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-Leucine and L-arginine and Physical Reconditioning by a trainer in people with Obesity and Metabolic Syndrome, run by University Hospital, Rouen 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 7 inclusion and 20 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 16 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?
Total body fat mass (time frame: 6 months). 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 NCT01326416, 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 16 Apr 2026.