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Bariatric surgery (BS), an effective treatment for severe obesity and its comorbidities, may result in micronutrient and vitamin deficiencies. This monocentric prospective observational study aimed at evaluating the efficacy of a specifically designed vitamin/mineral formula (Bariatrifast) for preventing and treating micronutrient deficiencies in patients submitted to BS.
Although BS effectively reduces body weight, improves metabolic alterations, and enhances overall health, it may also lead to micronutrients deficiency. This prospective observational study aimed at evaluating the effectiveness and safety of a specific FSMP (Food For Special Medical Purposes) in maintaining an adequate vitamin and micronutrient intake in patients with obesity submitted to VSG (Vertical Sleeve Gastrectomy) or RYGB (Roux-en-Y gastric bypass) . The included 20 consecutive patients with severe obesity who underwent BS (11 males, 9 females, all aged ≥18 years, with a BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with at least one obesity-related comorbidity, followed for one year after surgery.
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical efficacy of Bariatrifast on vitamins concentration | *25-OH Vitamin D3 in microgram/Liter (mcg/L) and vitamin B12 in nanogram/Liter (ng/L) | One year. The study protocol included a presurgical visit (V0), and 4 follow up visits at 1 (V1), 3 (V2), 6 (V3), and 12 (V4) months after BS |
| Measure | Description | Time Frame |
|---|---|---|
| evaluation of other parameters from blood test |
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Inclusion Criteria:
Exclusion Criteria:
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This observational, prospective study included 20 consecutive patients with severe obesity who underwent BS (11 males, 9 females, all aged ≥18 years, with a BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with at least one obesity-related comorbidity. In the, 10 patients had hypertension, 5 insulin resistance, 5 type 2 diabetes, 2 non-alcoholic liver disease, 7 gastroesophageal reflux disease, 7 dyslipidemia and 2 obstructive sleep apnea. Ten of them underwent VSG and the other 10 RYGB. Patients were recruited at the Obesity and Lipodystrophy Center, University Hospital of Pisa
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| Name | Affiliation | Role |
|---|---|---|
| Ferruccio Santini, MD | Obesity and Lipodystrophy Center, University Hospital of Pisa (Italy) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obesity and Lipodystrophy Center, University Hospital of Pisa | Pisa | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38714632 | Derived | Basolo A, Bechi Genzano S, Vitti J, Salvetti G, Gilio D, Ceccarini G, Scartabelli G, Lippi C, Bellini R, Mancini R, D'Imporzano S, Moretto C, Angeli V, Troiani D, Fierabracci P, Jaccheri R, Calderone A, Poma AM, Chiovato L, Saponati G, Santini F. Efficacy of multivitamin support following bariatric surgery in patients with obesity: a prospective observational study. Eat Weight Disord. 2024 May 7;29(1):34. doi: 10.1007/s40519-024-01655-7. |
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| One year. The study protocol included a presurgical visit (V0), and 4 follow up visits at 1 (V1), 3 (V2), 6 (V3), and 12 (V4) months after BS |
| evaluation of body composition | * Body weight (kilograms) | One year. The study protocol included a presurgical visit (V0), and 4 follow up visits at 1 (V1), 3 (V2), 6 (V3), and 12 (V4) months after BS |