Deglutition DisordersVEGENAT MEDNCT03727191
Coverage of Requirements After Consumption of a Nutritional Formula in Patients With Chewing/Swallowing Problems.
A study testing Experimental Group (education, guidelines, 2 pckts diet, recommendations) in people with Deglutition Disorders and Nutritional Deficiency, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Effect of a nutritional formula on the nutritional requirements in patients with chewing/swallowing problems during one month Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deglutition Disorders, Nutritional Deficiency, Chew Problems
- What is being tested?
- Experimental Group (education, guidelines, 2 pckts diet, recommendations)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2018to 1 Jun 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over 18 years old.
- Individuals with chewing/swallowing disorder.
- Individuals well nourished or at malnutrition risk.
- Adequate cultural level and understanding of the clinical trial.
- Signed informed consent.
Who cannot join
- Individuals with body mass index ≥40 kg/m2.
- Individuals with acute, severe or chronic disease without control.
- Individuals with major surgeries during the last month.
- Individuals with gastrointestinal surgery the last three months.
- Individuals with moderate/severe cognitive impairment.
- Individuals with severe malnutrition.
Show all 9Show fewer
- Individuals with amyotrophic lateral sclerosis.
- Individuals who consume nutritional oral supplements seven days prior to the start of the study.
- Enteral or parenteral nutrition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of the Consumption of a Hypercaloric/Hyperproteic Formula in the Coverage of Nutritional Requirements in Patients With Chewing/Swallowing Problems That Require a Shredded Diet.
Effect of a nutritional formula on the nutritional requirements in patients with chewing/swallowing problems during one month
Read the detailed description
30 patients will receive nutritional education and guidelines for the consumption of a completed shreded diet including 2 packets of 90 grams every day (One salted packet for lunch/dinner and one sweet packet for breakfast/afternoon snack) and recommendations for physical activity for one month.
30 patients will receive nutritional education, guidelines for the consumption of a completed shreded diet and recommendations for physical activity during one month.
- Being tested
- Control Group (education, guidelines, recommendations), Experimental Group (education, guidelines, 2 pckts diet, recommendations)
- Keywords
- Deglutition disorders, Nutritional deficiency, Chew problems, Swallowing disorder, Nutritional formula, Nutritional oral supplement
- Medical subject headings
- Deglutition Disorders, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Group (education, guidelines, recommendations)Other
Nutritional education and guidelines for the consumption of a completed shreded diet and recommendations for physical activity for one month.
Experimental Group (education, guidelines, 2 pckts diet, recommendations)Other
Nutritional education and guidelines for the consumption of a completed shreded diet including 2 packets of 90 grams every day and recommendations for physical activity for one month.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Nutritional education, guidelines for the consumption of a completed shreded diet and recommendations for physical activity. Receives: Other: Control Group (education, guidelines, recommendations) |
| Experimental Group | Experimental | Nutritional education and guidelines for the consumption of a completed shreded diet including: 2 packets of 90 grams every day (One salted packet for lunch/dinner and one sweet packet for breakfast/afternoon snack) and recommendations for physical activity for one month. Receives: Other: Experimental Group (education, guidelines, 2 pckts diet, recommendations) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of nutritional changes with regard to the nutritional requirements recommended
Change percentage = (energy consumption at the end of the intervention period - energy consumption at the beginning of the intervention period) / energy consumption at the beginning of the intervention period * 100
Measured: Up to one month
Secondary outcomes (8)
Change from Baseline Anthropometric Parameters
Weight and Height to calcule BMI in kg/m2
Measured: Up to one month
Change from Baseline Anthropometric Parameters
Waist Circumference
Measured: Up to one month
24h Dietary Recall Questionnaire
Food and activity habits of people
Measured: Up to one month
Adverse Effects
Gastrointestinal Symptoms (Nausea, Diarrhea, Bloating and other disorders)
Measured: Up to one month
Sensory perception
Sensory Perception Scale
Measured: Up to one month
Functionality Variables
Force dynamometry hand
Measured: Up to one month
Tolerance and adverse effects
Tolerance and adverse effects questionnaire
Measured: Up to one month
International Physical Activity Questionnaire
Activity habits of people
Measured: Up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start1 May 2018
- Primary completion1 Dec 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deglutition DisordersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Vegenat, S.A.
- Responsible party
- Sponsor
- Investigators
- Carmen Gómez Candela, PhD, MS, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727191
- Sponsor's protocol ID
- HULP 4985
- Acronym
- VEGENAT MED
- Status last verified
- Feb 2019
- First submitted
- 30 Oct 2018
- Last updated
- 14 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of the Consumption of a Hypercaloric/Hyperproteic Formula in the Coverage of Nutritional Requirements in Patients With Chewing/Swallowing Problems That Require a Shredded Diet.
- ClinicalTrials.gov ID
- NCT03727191
- Acronym / sponsor ID
- VEGENAT MED / HULP 4985
- Keywords
- Deglutition disorders, Nutritional deficiency, Chew problems, Swallowing disorder, Nutritional formula, Nutritional oral supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Vegenat, S.A.
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 1 Nov 2018 (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.
Effect of a nutritional formula on the nutritional requirements in patients with chewing/swallowing problems during one month
Detailed description
30 patients will receive nutritional education and guidelines for the consumption of a completed shreded diet including 2 packets of 90 grams every day (One salted packet for lunch/dinner and one sweet packet for breakfast/afternoon snack) and recommendations for physical activity for one month.
30 patients will receive nutritional education, guidelines for the consumption of a completed shreded diet and recommendations for physical activity during one month.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Control Group (education, guidelines, recommendations)Nutritional education, guidelines for the consumption of a completed shreded diet and recommendations for physical activity. |
| Experimental Group | Experimental | Other: Experimental Group (education, guidelines, 2 pckts diet, recommendations)Nutritional education and guidelines for the consumption of a completed shreded diet including: 2 packets of 90 grams every day (One salted packet for lunch/dinner and one sweet packet for breakfast/afternoon snack) and recommendations for physical activity for one month. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women over 18 years old.
- Individuals with chewing/swallowing disorder.
- Individuals well nourished or at malnutrition risk.
- Adequate cultural level and understanding of the clinical trial.
- Signed informed consent.
Key exclusion criteria (9 listed)
- Individuals with body mass index ≥40 kg/m2.
- Individuals with acute, severe or chronic disease without control.
- Individuals with major surgeries during the last month.
- Individuals with gastrointestinal surgery the last three months.
- Individuals with moderate/severe cognitive impairment.
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 |
|---|---|---|
| Control Group (education, guidelines, recommendations)Nutritional education and guidelines for the consumption of a completed shreded diet and recommendations for physical activity for one month. | Other | Control Group |
| Experimental Group (education, guidelines, 2 pckts diet, recommendations)Nutritional education and guidelines for the consumption of a completed shreded diet including 2 packets of 90 grams every day and recommendations for physical activity for one month. | Other | Experimental Group |
Primary outcome
Percentage of nutritional changes with regard to the nutritional requirements recommended
Time frame: Up to one month
Change percentage = (energy consumption at the end of the intervention period - energy consumption at the beginning of the intervention period) / energy consumption at the beginning of the intervention period * 100
8 secondary outcomes
Change from Baseline Anthropometric Parameters
Time frame: Up to one month
Change from Baseline Anthropometric Parameters
Time frame: Up to one month
24h Dietary Recall Questionnaire
Time frame: Up to one month
Adverse Effects
Time frame: Up to one month
Sensory perception
Time frame: Up to one month
Functionality Variables
Time frame: Up to one month
Tolerance and adverse effects
Time frame: Up to one month
International Physical Activity Questionnaire
Time frame: Up to one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
Carmen Gómez Candela, PhD, MS principal investigator
Hospital Universitario La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Group (education, guidelines, 2 pckts diet, recommendations) in people with Deglutition Disorders and Nutritional Deficiency, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of nutritional changes with regard to the nutritional requirements recommended (time frame: Up to one month). 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 14 Jun 2022.