NCT05806710

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 10, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2024

Completed
Last Updated

October 23, 2023

Status Verified

March 1, 2023

Enrollment Period

1.4 years

First QC Date

March 27, 2023

Last Update Submit

October 20, 2023

Conditions

Dysphagia

Keywords

dysphagiadietelderly subjects

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • evaluate the amount of GourMet© meal consumed

    after each GourMed© meal (up to day 7)

Study Arms (1)

dysphagic subjects

EXPERIMENTAL

elderly patients with dysphagia

Dietary Supplement: GourMed© meal

Interventions

GourMed© mealDIETARY_SUPPLEMENT

patients receive GourMed© meal as lunch for 7 consecutive days

dysphagic subjects

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

IRCCS INRCA Hospital

Casatenovo, Lecco, Italy

RECRUITING

Ospedale Mandic

Merate, Lecco, Italy

RECRUITING

IRCCS INRCA Hospital

Ancona, Italy

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

Anna Rita Bonfigli

CONTACT

0718003719a.bonfigli@inrca.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2023

First Posted

April 10, 2023

Study Start

October 12, 2022

Primary Completion

March 11, 2024

Study Completion

March 11, 2024

Last Updated

October 23, 2023

Record last verified: 2023-03

Locations

IT(3)