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

October 20, 2023 updated by: Istituto Nazionale di Ricovero e Cura per Anziani
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Ancona, Italy
    • Lecco
      • Casatenovo, Lecco, Italy
      • Merate, Lecco, Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dysphagic subjects
elderly patients with dysphagia
Dietary supplement: GourMed© meal
patients receive GourMed© meal as lunch for 7 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety of GourMed© meal
Time Frame: 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.
during each GourMed© meal (up to day 7)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluate the amount of GourMet© meal consumed
Time Frame: 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
after each GourMed© meal (up to day 7)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Nazionale di Ricovero e Cura per Anziani

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2022

Primary Completion (Estimated)

March 11, 2024

Study Completion (Estimated)

March 11, 2024

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

April 7, 2023

First Posted (Actual)

April 10, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INRCA_002_2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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