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

NCT ID: NCT05806710

Last Updated: 2023-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-12

Study Completion Date

2024-03-11

Brief Summary

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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

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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.

Conditions

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Dysphagia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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dysphagic subjects

elderly patients with dysphagia

Group Type EXPERIMENTAL

GourMed© meal

Intervention Type DIETARY_SUPPLEMENT

patients receive GourMed© meal as lunch for 7 consecutive days

Interventions

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GourMed© meal

patients receive GourMed© meal as lunch for 7 consecutive days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Nazionale di Ricovero e Cura per Anziani

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS INRCA Hospital

Casatenovo, Lecco, Italy

Site Status RECRUITING

Ospedale Mandic

Merate, Lecco, Italy

Site Status RECRUITING

IRCCS INRCA Hospital

Ancona, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Anna Rita Bonfigli

Role: CONTACT

0718003719

Facility Contacts

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Alessia Fumagalli, MD

Role: primary

Daniele Colombo, MD

Role: primary

Paolo Orlandoni, MD

Role: primary

Other Identifiers

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INRCA_002_2023

Identifier Type: -

Identifier Source: org_study_id

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