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

Sponsor
Istituto Nazionale di Ricovero e Cura per Anziani (Other)
Overall Status
Recruiting
CT.gov ID
NCT05806710
Collaborator
(none)
30
Enrollment
3
Locations
1
Arm
7.6
Anticipated Duration (Months)
10
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: GourMed© meal
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Safety and Acceptance of GourMed© Prepackaged Nutritional Products in the Elderly Dysphagic Patient: MODiet Project
Actual Study Start Date :
Oct 12, 2022
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
May 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: dysphagic subjects

elderly patients with dysphagia

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS INRCA Hospital Casatenovo Lecco Italy
2 Ospedale Mandic Merate Lecco Italy
3 IRCCS INRCA Hospital Ancona Italy

Sponsors and Collaborators

  • Istituto Nazionale di Ricovero e Cura per Anziani

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Istituto Nazionale di Ricovero e Cura per Anziani
ClinicalTrials.gov Identifier:
NCT05806710
Other Study ID Numbers:
  • INRCA_002_2023
First Posted:
Apr 10, 2023
Last Update Posted:
Apr 10, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Istituto Nazionale di Ricovero e Cura per Anziani
dysphagia
diet
elderly subjects
Additional relevant MeSH terms:
Deglutition Disorders

Study Results

No Results Posted as of Apr 10, 2023