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

ClinicalTrials.gov ID

NCT05806710

Lead Sponsor

Istituto Nazionale di Ricovero e Cura per AnzianiOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

30Estimated

Last Update Posted

Oct 23, 2023Actual

Start Date

Oct 12, 2022Actual

Primary Completion Date

Mar 11, 2024Estimated

Completion Date

Mar 11, 2024Estimated

Official Title

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

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.

• Dysphagia

• GourMed© meal

Ages Eligible for Study

Older Adult (65+)

Sexes Eligible for Study

All

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

Primary Purpose

Supportive Care

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Istituto Nazionale di Ricovero e Cura per AnzianiOTHER

d.colombo@inrca.it

p.orlandoni@inrca.it

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