Back to resultsSafety and Acceptance of GourMed© Prepackaged Nutritional Products in the Elderly Dysphagic Patient: MODiet Project (MODiet)
Primary Purpose
Dysphagia
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
GourMed© meal
Sponsored by
About this trial
This is an interventional supportive care trial for Dysphagia focused on measuring dysphagia, diet, elderly subjects
Eligibility Criteria
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
Sites / Locations
- IRCCS INRCA HospitalRecruiting
- Ospedale MandicRecruiting
- IRCCS INRCA HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
dysphagic subjects
Arm Description
elderly patients with dysphagia
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
evaluate the amount of GourMet© meal consumed
The amount of GourMet© meal is recorded to verify that the patient's nutritional needs are met
Full Information
NCT ID
NCT05806710
First Posted
March 27, 2023
Last Updated
October 20, 2023
Sponsor
Istituto Nazionale di Ricovero e Cura per Anziani
1. Study Identification
Unique Protocol Identification Number
NCT05806710
Brief Title
Safety and Acceptance of GourMed© Prepackaged Nutritional Products in the Elderly Dysphagic Patient: MODiet Project
Acronym
MODiet
Official Title
Safety and Acceptance of GourMed© Prepackaged Nutritional Products in the Elderly Dysphagic Patient: MODiet Project
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2022 (Actual)
Primary Completion Date
March 11, 2024 (Anticipated)
Study Completion Date
March 11, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Nazionale di Ricovero e Cura per Anziani
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
dysphagia, diet, elderly subjects
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dysphagic subjects
Arm Type
Experimental
Arm Description
elderly patients with dysphagia
Intervention Type
Dietary Supplement
Intervention Name(s)
GourMed© meal
Intervention Description
patients receive GourMed© meal as lunch for 7 consecutive days
Primary Outcome Measure Information:
Title
safety of GourMed© meal
Description
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.
Time Frame
during each GourMed© meal (up to day 7)
Secondary Outcome Measure Information:
Title
evaluate the amount of GourMet© meal consumed
Description
The amount of GourMet© meal is recorded to verify that the patient's nutritional needs are met
Time Frame
after each GourMed© meal (up to day 7)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Rita Bonfigli
Phone
0718003719
Email
a.bonfigli@inrca.it
Facility Information:
Facility Name
IRCCS INRCA Hospital
City
Casatenovo
State/Province
Lecco
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessia Fumagalli, MD
Email
a.fumagalli@inrca.it
Facility Name
Ospedale Mandic
City
Merate
State/Province
Lecco
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniele Colombo, MD
Email
d.colombo@inrca.it
Facility Name
IRCCS INRCA Hospital
City
Ancona
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Orlandoni, MD
Email
p.orlandoni@inrca.it
12. IPD Sharing Statement
Learn more about this trial
Safety and Acceptance of GourMed© Prepackaged Nutritional Products in the Elderly Dysphagic Patient: MODiet Project
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