DysphagiaNCT04305860
Acceptance of Different Thickeners in Dysphagia
A study testing Modified starch without flavoring, Mofidied starch with Bi1 aromas and Xanthan gum without flavoring in people with Dysphagia and Dysphagia, Oropharyngeal, run by Complexo Hospitalario Universitario de A Coruña at 1 site in Spain.
Trial summary
Randomized, controlled, pilot study of nutritional intervention to evaluate the acceptance to different kinds of thickeners, with and without the addition of flavoring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia, Dysphagia, Oropharyngeal
- What is being tested?
- Modified starch without flavoring, Mofidied starch with Bi1 aromas and Xanthan gum without flavoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 3 Feb 2020to 3 Mar 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
- Patients with oropharyngeal dysphagia for liquids diagnosed before admission or during hospitalization and who need thickener.
Who cannot join
- Patients with expected hospital length of stay less than 24 hours.
- Patients with food allergy to any of the ingredients of the thickener or flavorings used in the study.
- Patients with cognitive impairment that prevents collaborating in obtaining data.
- Patients in terminal situations, in which death is expected in the following hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptance of Different Types of Thickeners, With and Without Flavoring, in Patients With Dysphagia
Randomized, controlled, pilot study of nutritional intervention to evaluate the acceptance to different kinds of thickeners, with and without the addition of flavoring.
Read the detailed description
Background:
In patients with dyaphagia the modification of viscosity of oral liquids with thickeners ia needed to guarantee an effective and safe swallowing, and to ensure a proper state of hydration. There are two types of thickeners: thickeners obtained from modified starch or from food gums (suchxanthan gum)
Aim:
To evaluate the acceptance of different types of thickeners, with and without the addition of flavorings, and their relationship with water intake.
Methods:
Randomized, controlled, pilot study of nutritional intervention. Forty hospitalized patients with oropharyngeal dysphagia were randomized to 4 parallel groups: modified starch without flavoring, modified starch with flavoring, xanthan gum without flavoring, xanthan gum with flavoring. Each patient was asked to assess the odor, taste, appearance, and overall valoration of the thickened liquid with the different preparations, using a structured questionnaire. The number of glasses consumed by the patient over 3 consecutive days was also recorded to calculate de volume of liquid they consumed.
- Conditions
- Dysphagia, Dysphagia, Oropharyngeal
- Being tested
- Modified starch without flavoring, Mofidied starch with Bi1 aromas, Xanthan gum without flavoring, Xanthan gum with Bi1 aromas
- Keywords
- Thickener, Flavoring, Dysphagia
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified starch without flavoringDietary supplement
Each patient of this group receives the thickener during three days of hospitalization
Mofidied starch with Bi1 aromasDietary supplement
Each patient of this group receives the thickener and 5 flavorings during three days of hospitalization
Xanthan gum without flavoringDietary supplement
Each patient of this group receives the thickener during three days of hospitalization
Xanthan gum with Bi1 aromasDietary supplement
Each patient of this group receives the thickener and 5 flavorings during three days of hospitalization
| Study group | Role | What they receive |
|---|---|---|
| Modified starch without flavoring | Active comparator | Patients thicken water with modified starch during 3 days of hospitalization. They evaluate the organoleptic characteristics of the thickened liquid and register the volume of water intake. Receives: Dietary Supplement: Modified starch without flavoring |
| Modified starch with flavoring | Active comparator | Patients thicken water with modified starch adding any of 5 kinds of flavorings "Bi1 aromas" during 3 days of hospitalization. They evaluate the organoleptic characteristics of the thickened liquid and register the volume of water intake. Receives: Dietary Supplement: Mofidied starch with Bi1 aromas |
| Xanthan gum without flavoring | Active comparator | Patients thicken water with xanthan gum during 3 days of hospitalization. They evaluate the organoleptic characteristics of the thickened liquid and register the volume of water intake. Receives: Dietary Supplement: Xanthan gum without flavoring |
| Xanthan gum with flavoring | Active comparator | Patients thicken water with xanthan gum adding any of 5 kinds of flavorings "Bi1 aromas" during 3 days of hospitalization.They evaluate the organoleptic characteristics of the thickened liquid and register the volume of water intake. Receives: Dietary Supplement: Xanthan gum with Bi1 aromas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydratation
Volume of water ingested (ml)
Measured: 3 days during hospitalization
Taste
Semiquantitative scale of Punctuation of taste: 1-5 points (1: very bad; 2: bad; 3: intermediate; 4: Good; 5: very good).
Measured: 3 days during hospitalization
Odor
Semiquantitative scale of Punctuation of odor: 1-5 points (1: very bad; 2: bad; 3: intermediate; 4: Good; 5: very good).
Measured: 3 days during hospitalization
Appearance
Semiquantitative scale of Punctuation of appearance: 1-5 points (1: very bad; 2: bad; 3: intermediate; 4: Good; 5: very good).
Measured: 3 days during hospitalization
Overall valoration
Quantiative scale of Punctuation: 0-10 points (very bad to very good).
Measured: 3 days during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start3 Feb 2020
- Primary completion28 Feb 2020
- Study completion3 Mar 2020
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot study of nutritional intervention, randomized, and controlled
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Complexo Hospitalario Universitario de A Coruña
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfonso Vidal Casariego, Complexo Hospitalario Universitario de A Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305860
- Sponsor's protocol ID
- 2019-527
- Status last verified
- Mar 2020
- First submitted
- 3 Mar 2020
- Last updated
- 12 Mar 2020
- 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 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance of Different Types of Thickeners, With and Without Flavoring, in Patients With Dysphagia
- ClinicalTrials.gov ID
- NCT04305860
- Acronym / sponsor ID
- 2019-527
- Conditions
- Dysphagia, Dysphagia, Oropharyngeal
- Keywords
- Thickener, Flavoring, Dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Complexo Hospitalario Universitario de A CoruñaUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 12 Mar 2020 (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.
Randomized, controlled, pilot study of nutritional intervention to evaluate the acceptance to different kinds of thickeners, with and without the addition of flavoring.
Detailed description
Background:
In patients with dyaphagia the modification of viscosity of oral liquids with thickeners ia needed to guarantee an effective and safe swallowing, and to ensure a proper state of hydration. There are two types of thickeners: thickeners obtained from modified starch or from food gums (suchxanthan gum)
Aim:
To evaluate the acceptance of different types of thickeners, with and without the addition of flavorings, and their relationship with water intake.
Methods:
Randomized, controlled, pilot study of nutritional intervention. Forty hospitalized patients with oropharyngeal dysphagia were randomized to 4 parallel groups: modified starch without flavoring, modified starch with flavoring, xanthan gum without flavoring, xanthan gum with flavoring. Each patient was asked to assess the odor, taste, appearance, and overall valoration of the thickened liquid with the different preparations, using a structured questionnaire. The number of glasses consumed by the patient over 3 consecutive days was also recorded to calculate de volume of liquid they consumed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Pilot study of nutritional intervention, randomized, and controlled
| Arm | Type | Receives |
|---|---|---|
| Modified starch without flavoring | Active comparator | Dietary Supplement: Modified starch without flavoringPatients thicken water with modified starch during 3 days of hospitalization. They evaluate the organoleptic characteristics of the thickened liquid and register the volume of water intake. |
| Modified starch with flavoring | Active comparator | Dietary Supplement: Mofidied starch with Bi1 aromasPatients thicken water with modified starch adding any of 5 kinds of flavorings "Bi1 aromas" during 3 days of hospitalization. They evaluate the organoleptic characteristics of the thickened liquid and register the volume of water intake. |
| Xanthan gum without flavoring | Active comparator | Dietary Supplement: Xanthan gum without flavoringPatients thicken water with xanthan gum during 3 days of hospitalization. They evaluate the organoleptic characteristics of the thickened liquid and register the volume of water intake. |
| Xanthan gum with flavoring | Active comparator | Dietary Supplement: Xanthan gum with Bi1 aromasPatients thicken water with xanthan gum adding any of 5 kinds of flavorings "Bi1 aromas" during 3 days of hospitalization.They evaluate the organoleptic characteristics of the thickened liquid and register the volume of water intake. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with oropharyngeal dysphagia for liquids diagnosed before admission or during hospitalization and who need thickener.
Key exclusion criteria (4 listed)
- Patients with expected hospital length of stay less than 24 hours.
- Patients with food allergy to any of the ingredients of the thickener or flavorings used in the study.
- Patients with cognitive impairment that prevents collaborating in obtaining data.
- Patients in terminal situations, in which death is expected in the following hours.
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 |
|---|---|---|
| Modified starch without flavoringEach patient of this group receives the thickener during three days of hospitalization | Dietary supplement | Modified starch without flavoring |
| Mofidied starch with Bi1 aromasEach patient of this group receives the thickener and 5 flavorings during three days of hospitalization | Dietary supplement | Modified starch with flavoring |
| Xanthan gum without flavoringEach patient of this group receives the thickener during three days of hospitalization | Dietary supplement | Xanthan gum without flavoring |
| Xanthan gum with Bi1 aromasEach patient of this group receives the thickener and 5 flavorings during three days of hospitalization | Dietary supplement | Xanthan gum with flavoring |
Primary outcome
Hydratation
Time frame: 3 days during hospitalization
Volume of water ingested (ml)
Taste
Time frame: 3 days during hospitalization
Semiquantitative scale of Punctuation of taste: 1-5 points (1: very bad; 2: bad; 3: intermediate; 4: Good; 5: very good).
Odor
Time frame: 3 days during hospitalization
Semiquantitative scale of Punctuation of odor: 1-5 points (1: very bad; 2: bad; 3: intermediate; 4: Good; 5: very good).
Appearance
Time frame: 3 days during hospitalization
Semiquantitative scale of Punctuation of appearance: 1-5 points (1: very bad; 2: bad; 3: intermediate; 4: Good; 5: very good).
Overall valoration
Time frame: 3 days during hospitalization
Quantiative scale of Punctuation: 0-10 points (very bad to very good).
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 12 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified starch without flavoring, Mofidied starch with Bi1 aromas and Xanthan gum without flavoring in people with Dysphagia and Dysphagia, Oropharyngeal, run by Complexo Hospitalario Universitario de A Coruña 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 1 inclusion and 4 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 12 Mar 2020. 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?
Hydratation (time frame: 3 days during hospitalization). The study lists 5 primary outcomes in all. 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 12 Mar 2020.