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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05806710

Acronym

MODiet

Enrollment

Registered

2023-04-10

Start date

2022-10-12

Completion date

2024-03-11

Last updated

2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia

Keywords

dysphagia, diet, elderly subjects

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.

Interventions

DIETARY_SUPPLEMENTGourMed© meal

patients receive GourMed© meal as lunch for 7 consecutive days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
safety of GourMed© meal	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.

Secondary

Measure	Time frame	Description
evaluate the amount of GourMet© meal consumed	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

Countries

Italy

Contacts

Primary ContactAnna Rita Bonfigli

a.bonfigli@inrca.it0718003719

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026