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NCT Number: NCT01326416

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

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.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Rouen

Rouen, 76031, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Total body fat mass

    Time frame: 6 months

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

Secondary outcomes

  1. Weight

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

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

Acronym: OBEFITT

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Mar 30, 2011
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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