Post-bariatric Surgery Weaning With Food for Special Medical Purposes to Increase Patient Compliance.

NCT06205017 | Unknown DMC

• 1 other identifier: AFMS_FOOD (L4190)
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month

Study Arms (2)

Group A (AFSM)

EXPERIMENTAL

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

Group B (protocol in use with homogenized)

NO INTERVENTION

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.

Interventions

Foods for Special Medical Purposes DIETARY_SUPPLEMENT

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.

Group A (AFSM)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥18 and ≤ of 60
• Subjects with severe or morbid obesity (BMI ≥ 35 kg/m2 in the presence of comorbidities and BMI ≥ 40 kg/m2)
• Absence of diagnosis of primary obesity
• Absence of medical/psychiatric contraindications
• Signature of informed consent for the study
• Patients who are candidates by clinical practice for bariatric surgery (Sleeve Gastrectomy and Roux-en-Y Gastric Bypass).

You may not qualify if:

• Presence of chronic diseases of the digestive system, such as chronic diseases intestinal, malabsorption syndrome, diverticulosis of the colon
• Current pregnancy (verified by self-declaration) and/or lactation
• Subjects with endocrine disorders (e.g., Cushing's m., thyroid disease uncontrolled)
• Presence of known renal insufficiency or creatinine levels greater than 1.8 mg/dl and eGFR \< 60 ml/min
• Presence of malignant pathology
• Alcohol or drug abuse
• Severe psychological/psychiatric disorders
• Difficulty adhering to the protocol due to language barriers or other reasons.

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

MeSH Terms

Interventions

Food

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The sample size was calculated in order to identify differences significant in the increase of liking in the study group compared with the control. According to the PI's experience, the frequency of liking in the group control is 5% and this is expected to increase to 70% in the study group. Considering using a Fisher's exact test with alpha level=0.05, to obtain a power of 95%, 14 patients per group are needed. This number is increased by 10% in case of possible dropouts, for a total of 16 subjects per group and 32 total.

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 12, 2024
• Study Start: January 9, 2024
• Primary Completion: July 9, 2024
• Study Completion: August 9, 2024
• Last Updated: January 12, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share