Evaluation of the Impact of Physical Reconditioning Associated With Specific Nutritional Supplementation in Obese Patients Suffering From Metabolic Syndrome

Obesity Clinical Trial

— OBEFITT  

Official title:

Evaluation of the Impact of Physical Reconditioning Associated With Specific Nutritional Supplementation in Obese Patients Suffering From Metabolic Syndrome. OBEFITT Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01326416
• Other study ID #: 2008/066/HP
• Status: Completed
• Phase: N/A
• First received: March 29, 2011
• Last updated: January 22, 2016
• Start date: March 2011
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Syndrome

Intervention

Dietary Supplement:
• L-Leucine and L-arginine
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.

Other:
• Physical Reconditioning by a trainer
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.

Locations

Country	Name	City	State
France	University Hospital of Rouen	Rouen Cedex

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total body fat mass	Change in total body fat mass estimated by Dual-energy X-Ray Absorptiometry (DEXA).	6 months	No
Secondary	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.	6 months	No