An interventional study of Foods for Special Medical Purposes in Bariatric Surgery, sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-01-12.
Sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Not applicable, Interventional, and Other
Due to the reduced volume and postoperative gastric edema, ingestion of solid foods in the first few days after surgery is very difficult or impossible; following bariatric surgery there are anatomical changes in the vagus that may contribute to the alteration of taste perception. In order to facilitate patient weaning and improve the liking of the foods used in this semi-liquid phase, our Center intends to test some "Foods for Special Medical Purposes" (AFMS), in order to ensure a better intake of nutrition, including in terms of vitamin D3 and calcium, good palatability and thus a better adherence to the recommended nutritional indications in the immediate postoperative period than the homogenized foods used in the standard diet.
Primary goal: Patient compliance throughout the weaning period (4 weeks postintervention), assessed through product liking measurable by Sensory Questionnaire.
Secondary objective:
Nutritional efficacy (assessment of blood levels of micronutrients such as. iron, ferritin, transferrin , calcium, vit D3, folic ac, vit B12 and of macronutrients such as total protein and protein electrophoresis; bioimpedance analysis for body composition assessment).
32 subjects with severe or morbid obesity ( BMI ≥ 35 kg/m2 in the presence of comorbidities and BMI ≥ 40 kg/m2 , respectively), male and female, candidates for bariatric surgery (Sleeve Gastrectomy and Roux-en-Y Gastric Bypass).
Two timepoints: T0 (pre-rev) and T1 (follow-up 1 month +/-7 days). Planned assessments at T0 and T1.
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio is the lead sponsor of 157 studies on the registry; 58 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
16 subjects (Group A: intervention group) will take AFSMs in the immediate postoperative period (Appendix A). A weaning period with AFSM nutritional protocol of 4 weeks is planned, the weaning will cover the entire observation period T0 → T1.
Dietary Supplement: Foods for Special Medical Purposes
16 subjects (Group B: control group) will follow the standard weaning protocol i.e. with homogenized food (Appendix B). A weaning period with nutritional protocol, as per clinical protocol, of 4 weeks is planned, weaning will cover the entire observation period T0 → T1.
In order to facilitate patient weaning and to improve the enjoyment of foods used in this semi-liquid phase, our Center intends to test "Foods for Special Medical Purposes" (AFMS) to ensure better nutritional intake, including vitamin D3 and calcium, good palatability, and thus better adherence to the recommended nutritional indications in the immediate postoperative period than the homogenized foods used in the standard diet.
Patient compliance throughout the weaning period
Patient compliance throughout the weaning period (4 weeks post-intervention), assessed through satisfaction with the products measurable with a questionnaire sensory.
Time frame: 1 month
No study locations are listed for this record.
Plan to share: No
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This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio