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| ID | Type | Description | Link |
|---|---|---|---|
| UF 9590 | Other Identifier | Montpellier University Hospital |
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The main objective will be to evaluate the effect at 5 weeks of nutritional management associated with protein supplementation (adapted to the post-operative period) on the maintenance of lean body mass at the whole body in obese patients after a sleeve gastrectomy.
Secondary objectives will assess protein intake, food safety, the effect of protein supplementation on body fat in the entire body and the metabolic rate and the impact on quality of life and post-operative joint pain.
The main objective will be to evaluate the effect at 5 weeks of nutritional management associated with protein supplementation (adapted to the post-operative period) on the maintenance of lean body mass at the whole body in obese patients after a sleeve gastrectomy.
Secondary objectives will assess protein intake, food safety, the effect of protein supplementation on body fat in the entire body and the metabolic rate and the impact on quality of life and post-operative joint pain.
There is still no study evaluating the protein supplementation adapted patients after sleeve gastrectomy on maintaining lean body mass.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| usual dietary management | No Intervention | Control group: usual dietary management Following the intervention, the stomach of patients underwent many changes | |
| care of with usual dietary protein supplementation | Experimental | Intervention group: Usual dietary management with protein supplementation (30g) in addition to the usual inputs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| protein supplementation | Other | Protein supplementation : Protein intake of 30 grams of protein in addition to the usual inputs (to the recommended amounts of 60 to 120 g per day), upon the resumption of oral intake until the fifth week after sleeve gastrectomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in lean mass (kg) will be assessed at the level of whole-body dual-energy X-ray absorptiometry (DXA) | up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| food diary | The actual protein intake will be assessed using a food diary over 5 weeks completed by the patient | 5 weeks after the hospital discharge |
| change rate IGF1, IGFBP3 | change rate IGF1, IGFBP3 between hospitalization and 1 month of hospital discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David NOCCA | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UHMontpellier | Montpellier | France | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37892386 | Result | Maimoun L, Aouinti S, Puech M, Lefebvre P, Deloze M, de Santa Barbara P, Cristol JP, Brabant S, Gautier T, Nedelcu M, Renard E, Picot MC, Mariano-Goulart D, Nocca D. Effect of Nutritional Deprivation after Sleeve Gastrectomy on Bone Mass, Periostin, Sclerostin and Semaphorin 4D: A Two-Year Longitudinal Study. Nutrients. 2023 Oct 10;15(20):4310. doi: 10.3390/nu15204310. | |
| 36904198 |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| up to 1 month |
| the quality of life | The evolution of the quality of life will be assessed through a specific scale, Baros score. | up to 1 month |
| the quality of life | The evolution of the quality of life will be assessed through a specific scale, Baros score. | up to 5 years |
| change rate IGF1, IGFBP3 | change rate IGF1, IGFBP3 between hospitalization and 5 years follow up | up to 5 years |
| Maimoun L, Aouinti S, Puech M, Lefebvre P, Deloze M, de Santa Barbara P, Renard E, Christol JP, Myzia J, Picot MC, Mariano-Goulart D, Nocca D. Changes in Lean Tissue Mass, Fat Mass, Biological Parameters and Resting Energy Expenditure over 24 Months Following Sleeve Gastrectomy. Nutrients. 2023 Feb 27;15(5):1201. doi: 10.3390/nu15051201. |
| 39693376 | Result | Maimoun L, Aouinti S, Puech M, Lefebvre P, Humbert L, Deloze M, de Santa Barbara P, Maimoun-Nande L, Boudousq V, Cristol JP, Renard E, Picot MC, Mariano-Goulart D, Nocca D. Modification of bone architecture following sleeve gastrectomy: a five-year follow-up. J Bone Miner Res. 2025 Feb 2;40(2):251-261. doi: 10.1093/jbmr/zjae202. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |