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

Purpose

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.

Condition	Intervention
Obesity Metabolic Syndrome	Dietary Supplement: L-Leucine and L-arginine Other: Physical Reconditioning by a trainer

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evaluation of the Impact of Physical Reconditioning Associated With Specific Nutritional Supplementation in Obese Patients Suffering From Metabolic Syndrome. OBEFITT Study.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Dietary Supplements Metabolic Syndrome Obesity

Drug Information available for: Leucine Arginine Arginine Hydrochloride

U.S. FDA Resources

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:

Total body fat mass [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change in total body fat mass estimated by Dual-energy X-Ray Absorptiometry (DEXA).

Secondary Outcome Measures:

Weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	100
Study Start Date:	March 2011
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: S: Nutritional Supplementation alone 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.	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.
Active Comparator: A: Physical Reconditioning alone Physical reconditioning sessions led by a trainer three times a week for 6 months.	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.
Active Comparator: AS: Physical Reconditioning + Nutritional Supplementation 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.	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.
No Intervention: C: Lifestyle counseling Usual advice given in consultation on the need for a balanced diet and regular physical activity

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326416

Contacts

Contact: Vanessa FOLOPE, M.D.	0033 232 88 81 22	vanessa.folope@chu-rouen.fr
Contact: Pierre DECHELOTTE, M.D., Ph.D.	0033 232 88 81 22	pierre.dechelotte@chu-rouen.fr

Locations

France
University Hospital of Rouen	Recruiting
Rouen Cedex, France, 76031
Contact: Caroline Meret 0033 7 86 96 41 65 obefit@chu-rouen.fr
Principal Investigator: Vanessa Folope, M.D.

Sponsors and Collaborators

University Hospital, Rouen

More Information

No publications provided

Responsible Party:	University Hospital, Rouen
ClinicalTrials.gov Identifier:	NCT01326416 History of Changes
Other Study ID Numbers:	2008/066/HP
Study First Received:	March 29, 2011
Last Updated:	April 17, 2013
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:

obesity
metabolic syndrome
leucine
arginine
physical activity

Additional relevant MeSH terms:

Obesity
Metabolic Syndrome X
Stress, Psychological
Overnutrition
Nutrition Disorders
Overweight
Body Weight

Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 23, 2013

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