DysphagiaMODietNCT05806710
Safety and Acceptance of GourMed© Prepackaged Nutritional Products in the Elderly Dysphagic Patient: MODiet Project
A study testing GourMed© meal in people with Dysphagia, run by Istituto Nazionale di Ricovero e Cura per Anziani at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- GourMed© meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesItaly
- Study dates
- 12 Oct 2022to 11 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age 65 years and over
- Gugging Swallowing Screen ranging 10-20;
Who cannot join
- known or suspected intolerance to any ingredient
- taking other prepackaged products for dysphagia
- creatinine ≥1,5 mg/dl
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 3 recruiting
- Recruiting
IRCCS INRCA Hospital
Ancona
Paolo Orlandoni, MD, p.orlandoni@inrca.it
- Recruiting
IRCCS INRCA Hospital
Casatenovo, Lecco
Alessia Fumagalli, MD, a.fumagalli@inrca.it
- Recruiting
Ospedale Mandic
Merate, Lecco
Daniele Colombo, MD, d.colombo@inrca.it
About this study
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.
Read the 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.
- Conditions
- Dysphagia
- Being tested
- GourMed© meal
- Keywords
- dysphagia, diet, elderly subjects
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GourMed© mealDietary supplement
patients receive GourMed© meal as lunch for 7 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| dysphagic subjects | Experimental | elderly patients with dysphagia Receives: Dietary Supplement: GourMed© meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during each GourMed© meal (up to day 7)
Secondary outcomes (1)
evaluate the amount of GourMet© meal consumed
The amount of GourMet© meal is recorded to verify that the patient's nutritional needs are met
Measured: after each GourMed© meal (up to day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start12 Oct 2022
- Primary completion11 Mar 2024 (estimated)
- Study completion11 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806710
- Sponsor's protocol ID
- INRCA_002_2023
- Acronym
- MODiet
- Status last verified
- Mar 2023
- First submitted
- 27 Mar 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Acceptance of GourMed© Prepackaged Nutritional Products in the Elderly Dysphagic Patient: MODiet Project
- ClinicalTrials.gov ID
- NCT05806710
- Acronym / sponsor ID
- MODiet / INRCA_002_2023
- Conditions
- Dysphagia
- Keywords
- dysphagia, diet, elderly subjects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 11 Mar 2024 (estimated)
- Study completion
- 11 Mar 2024 (estimated)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dysphagic subjects | Experimental | Dietary Supplement: GourMed© mealelderly patients with dysphagia |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- age 65 years and over
- Gugging Swallowing Screen ranging 10-20;
Key exclusion criteria (3 listed)
- known or suspected intolerance to any ingredient
- taking other prepackaged products for dysphagia
- creatinine ≥1,5 mg/dl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GourMed© mealpatients receive GourMed© meal as lunch for 7 consecutive days | Dietary supplement | dysphagic subjects |
Primary outcome
safety of GourMed© meal
Time frame: 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.
1 secondary outcome
evaluate the amount of GourMet© meal consumed
Time frame: after each GourMed© meal (up to day 7)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GourMed© meal in people with Dysphagia, run by Istituto Nazionale di Ricovero e Cura per Anziani at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Rita Bonfigli (0718003719, a.bonfigli@inrca.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety of GourMed© meal (time frame: during each GourMed© meal (up to day 7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.