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

NCT01326416 | Completed DMC

• 2 other identifiers: 2008/066/HP2009-009155-37
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Metabolic Syndrome

Keywords

obesity; metabolic syndrome; leucine; arginine; physical activity

Outcome Measures

Primary Outcomes (1)

• Total body fat mass

  Change in total body fat mass estimated by Dual-energy X-Ray Absorptiometry (DEXA).

  6 months

Secondary Outcomes (1)

• Weight

  6 months

Study Arms (4)

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.

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.

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

Interventions

L-Leucine and L-arginine DIETARY_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.

S: Nutritional Supplementation alone

Physical Reconditioning by a trainer OTHER

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.

A: Physical Reconditioning alone

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Affiliated to a National Insurance scheme
• Having National Social Security insurance

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

University Hospital of Rouen

Rouen, 76031, France

Location

Related Publications (3)

• Folope V,Meret C,Castres I,Tourny C,Houivet E,Grigioni S,Lelandais H,Petit A,Coquard A,Guérin C,Quillard M,Bôle-Feysot C,Déchelotte P,Achamrah N,Coëffier M

  RESULT

• Évaluation 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

  RESULT

• 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.

  PMID: 26694707 RESULT

MeSH Terms

Conditions

Obesity; Metabolic Syndrome; Motor Activity

Interventions

Leucine; Arginine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Amino Acids, Basic; Amino Acids, Diamino

Study Officials

• Vanessa FOLOPE, M.D.

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2011
• First Posted: March 30, 2011
• Study Start: March 1, 2011
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

FR (1)