Safety and Acceptance of GourMed© Prepackaged Nutritional Products in the Elderly Dysphagic Patient: MODiet Project

Not Applicable

Recruiting

• Conditions: Dysphagia
• Interventions: Dietary Supplement: GourMed© meal

• Registration Number: NCT05806710
• Lead Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani

Brief Summary

The aim of the MoDiet study is to evaluate the usefulness of the GourMed© prepackaged diet in guaranteeing a safe, compliant and effective diet satisfying the nutritional needs of the elderly dysphagic patient.

Detailed Description

The objective of the MoDiet study is to evaluate the usefulness of the GourMed© (MedicAir Food srl, Milano, Italy) prepackaged diet in guaranteeing a safe, compliant and effective diet satisfying the nutritional needs of the elderly dysphagic patient.

Study Timeline

• Study Start: 2022-10-12
• Status Verified: 2023-03
• Study First Submitted: 2023-03-27
• Study First Submitted QC: 2023-04-07
• Study First Posted: 2023-04-10
• Last Update Submitted: 2023-10-20
• Last Update Posted: 2023-10-23
• Primary Completion: 2024-03-11
• Study Completion: 2024-03-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• age 65 years and over
• Gugging Swallowing Screen ranging 10-20;

Exclusion Criteria

• known or suspected intolerance to any ingredient
• taking other prepackaged products for dysphagia
• creatinine ≥1,5 mg/dl

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dysphagic subjects	GourMed© meal	elderly patients with dysphagia

Primary Outcome Measures

Name	Time	Method
safety of GourMed© meal	during each GourMed© meal (up to day 7)	The safety of GourMed© meal is monitoring by the registration of the following events: * Appearance of coughing and/or changes in the tone of voice immediately after or within 1-2 minutes of swallowing a bite; * Spill of food from the nose; * Prolonged management of the bolus in the oral cavity; * Appearance of red or cyanotic color on the face; * Occurrence of allergic skin reactions; * Appearance of breathing difficulties; * Onset of fever; * Appearance of nausea, vomiting or diarrhea.

Secondary Outcome Measures

Name	Time	Method
evaluate the amount of GourMet© meal consumed	after each GourMed© meal (up to day 7)	The amount of GourMet© meal is recorded to verify that the patient's nutritional needs are met

Trial Locations

Locations (2)

IRCCS INRCA Hospital; 🇮🇹 Ancona, Italy

Ospedale Mandic; 🇮🇹 Merate, Lecco, Italy