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

Primary Purpose

Obesity, Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

L-Leucine and L-arginine

Physical Reconditioning by a trainer

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, metabolic syndrome, leucine, arginine, physical activity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University Hospital of Rouen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

No Intervention

Arm Label

S: Nutritional Supplementation alone

A: Physical Reconditioning alone

AS: Physical Reconditioning + Nutritional Supplementation

C: Lifestyle counseling

Arm Description

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.

Physical reconditioning sessions led by a trainer three times a week for 6 months.

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.

Usual advice given in consultation on the need for a balanced diet and regular physical activity

Outcomes

Primary Outcome Measures

Total body fat mass

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01326416

First Posted

March 29, 2011

Last Updated

January 22, 2016

Sponsor

University Hospital, Rouen

1. Study Identification

Unique Protocol Identification Number

NCT01326416

Brief Title

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

Acronym

OBEFITT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Rouen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Metabolic Syndrome

Keywords

obesity, metabolic syndrome, leucine, arginine, physical activity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

79 (Actual)

8. Arms, Groups, and Interventions

Arm Title

S: Nutritional Supplementation alone

Arm Type

Active Comparator

Arm Description

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.

Arm Title

A: Physical Reconditioning alone

Arm Type

Active Comparator

Arm Description

Physical reconditioning sessions led by a trainer three times a week for 6 months.

Arm Title

AS: Physical Reconditioning + Nutritional Supplementation

Arm Type

Active Comparator

Arm Description

Arm Title

C: Lifestyle counseling

Arm Type

No Intervention

Arm Description

Usual advice given in consultation on the need for a balanced diet and regular physical activity

Intervention Type

Dietary Supplement

Intervention Name(s)

L-Leucine and L-arginine

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Physical Reconditioning by a trainer

Intervention Description

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 Outcome Measure Information:

Title

Total body fat mass

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Weight

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vanessa FOLOPE, M.D.

Organizational Affiliation

Rouen University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of Rouen

City

Rouen Cedex

ZIP/Postal Code

76031

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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