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The purpose of the study is to test whether additional protein intake with or without strength training will help to maintain body composition (fat-free mass) after surgical treatment of obesity by gastric by pass. The main hypothesis is that additional protein intake will limit fat-free mass loss during surgery-induced weight loss, and that strength training will have an additional beneficial effect
Design: Open randomised controlled trial comparing, in obese patients after GBP, an additional oral intake of protein with or without a muscular-strengthening physical training programme (18 weeks) to standard medical and nutritional follow-up after bariatric surgery as control (3 groups). Primary outcome: Variation at 6 months after GBP in total and appendicular fat-free mass as assessed by dual-energy X-ray absorptiometry (DXA). Duration of the study: 36 months. Duration of participation for one patient: 7 months. Number of centers: Monocentric study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard treatment - usual care | No Intervention | ||
| Protein supplementation | Experimental |
| |
| Protein supplementation and strength training | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein supplementation and strength training | Behavioral | Protein supplementation and strength training |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in fat-free mass at 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Variation at 6 months after GBP of other body composition components | 6 months | |
| Variation at 6 months after GBP in dietary habits | 6 months | |
| Variation at 6 months after GBP in muscular strength and habitual physical activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Michel OPPERT, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GH-Pitié-Salpêtrière | Paris | 75013 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31073952 | Derived | Bellicha A, Ciangura C, Roda C, Torcivia A, Portero P, Oppert JM. Changes in Cardiorespiratory Fitness After Gastric Bypass: Relations with Accelerometry-Assessed Physical Activity. Obes Surg. 2019 Sep;29(9):2936-2941. doi: 10.1007/s11695-019-03932-2. | |
| 30358153 | Derived | Oppert JM, Bellicha A, Roda C, Bouillot JL, Torcivia A, Clement K, Poitou C, Ciangura C. Resistance Training and Protein Supplementation Increase Strength After Bariatric Surgery: A Randomized Controlled Trial. Obesity (Silver Spring). 2018 Nov;26(11):1709-1720. doi: 10.1002/oby.22317. |
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| Protein supplementation | Dietary Supplement | Protein supplementation |
|
| 6 months |
| Variation at 6 months after GBP in quality of life and obesity co-morbidities | 6 months |
| Variation at 6 months after GBP in obesity-associated inflammatory markers | 6 months |
| ID | Term |
|---|---|
| D009765 | Obesity |
| 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 |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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