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

Dysphagia Clinical Trial

— MODiet  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05806710
• Other study ID #: INRCA_002_2023
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2022
• Est. completion date: March 11, 2024

Study information

• Verified date: March 2023
• Source: Istituto Nazionale di Ricovero e Cura per Anziani
• Contact: Anna Rita Bonfigli
• Phone: 0718003719
• Email: a.bonfigli[@]inrca.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 11, 2024
• Est. primary completion date: March 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

Dietary Supplement:
• GourMed© meal
patients receive GourMed© meal as lunch for 7 consecutive days

Locations

Country	Name	City	State
Italy	IRCCS INRCA Hospital	Ancona
Italy	IRCCS INRCA Hospital	Casatenovo	Lecco
Italy	Ospedale Mandic	Merate	Lecco

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Nazionale di Ricovero e Cura per Anziani

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety of GourMed© meal	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.	during each GourMed© meal (up to day 7)
Secondary	evaluate the amount of GourMet© meal consumed	The amount of GourMet© meal is recorded to verify that the patient's nutritional needs are met	after each GourMed© meal (up to day 7)