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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-009155-37 | EudraCT Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| A: Physical Reconditioning alone | Active Comparator | Physical reconditioning sessions led by a trainer three times a week for 6 months. |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total body fat mass | Change in total body fat mass estimated by Dual-energy X-Ray Absorptiometry (DEXA). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vanessa FOLOPE, M.D. | University Hospital, Rouen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Rouen | Rouen | 76031 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36145083 | Result | Folope V, Meret C, Castres I, Tourny C, Houivet E, Grigioni S, Lelandais H, Petit A, Coquard A, Guerin C, Quillard M, Bole-Feysot C, Dechelotte P, Achamrah N, Coeffier M. Evaluation of a Supervised Adapted Physical Activity Program Associated or Not with Oral Supplementation with Arginine and Leucine in Subjects with Obesity and Metabolic Syndrome: A Randomized Controlled Trial. Nutrients. 2022 Sep 8;14(18):3708. doi: 10.3390/nu14183708. | |
| 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 | ||
| 26694707 |
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| 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. |
|
| 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. |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D007930 | Leucine |
| D001120 | Arginine |
| ID | Term |
|---|---|
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D024361 | Amino Acids, Basic |
| D000599 | Amino Acids, Diamino |
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