DysphagiaNCT01270204
The Effect of Food Taste, Temperature, and Viscosity on Swallowing Efficiency
An observational study of Dysphagia, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of taste on swallowing efficiency, to evaluate the effect of temperature on swallowing efficiency, and to evaluate the effect of viscosity on swallowing efficiency. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dysphagia
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Nov 2012
- Phase
- Observational
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 40 dysphagic volunteers and 10 healthy volunteers
Who may be able to join
- Normal Volunteers:
- Older than 55 years of age
- No history of voice, swallowing, reflux, or progressive neurologic disease affecting the swallowing mechanism.
- A normal self-administered dysphagia questionnaire (EAT-10 score of less than three)
- Patients with Dysphagia
- Older than 55 years of age
- Patients with the following condition: Dysphagia, globus, gastroesophageal reflux, or any other condition requiring referral for a dynamic swallowing study.
- Patients willing to provide written informed consent for their participation in the study.
Who cannot join
- Patients unable to complete the administration of the full taste and viscosity protocol.
- Patients with profound dysphagia unable to safely consume the test solutions.
- Patients with known sensitivities or allergies to any of the test solutions.
- Patients who are prisoners.
- Patients have a history of diabetes.
- Patients who are unable to follow the simple instructions to swallow the test solutions on instruction and answer the questionnaire.
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Department of Otolaryngology
Sacramento, California, 95817
About this study
The purpose of this study is to evaluate the effect of taste on swallowing efficiency, to evaluate the effect of temperature on swallowing efficiency, and to evaluate the effect of viscosity on swallowing efficiency.
Read the detailed description
Swallowing problems (dysphagia) are encountered frequently in primary practice and in the hospital setting. The list of possible causes is large, ranging from strokes and neurological disease to complications of cancer treatment, acid reflux, and surgery. Many patients have a reduced ability to feel food and fluid (reduced sensation) within the throat (pharynx) and this leads to an inability to manipulate food and fluids in the correct manner. This can produce a variety of swallowing problems such as choking on foods and fluids, regurgitation, aspiration, weight loss, malnutrition and poor quality of life.
Treatment of dysphagia is largely directed at rehabilitation of muscle power and education about safe swallowing techniques or positioning that limits food and fluid from entering the airway. One of the most widely accepted treatments of dysphagia is to alter the texture of food. Most patients with dysphagia will have more difficulty swallowing thin liquids. By adding a thickener to the liquid, a food bolus becomes more cohesive, and is less likely to become aspirated. Various types of thickening products are available over-the-counter without a prescription. These thickening products are bland and currently have no flavor. We hypothesize that alterations in food taste (sweet, salty, etc…), viscosity, and temperature, will improve swallowing efficiency. The purpose of this investigation is to evaluate the effects of food taste, texture, and temperature on swallowing efficiency. The goal is to develop safer, better tasting food products and improve the quality of life in patients with disabling swallowing disorders.
- Conditions
- Dysphagia
- Keywords
- Dysphagia, Swallowing Problems, Dynamic Fluoroscopic Swallow Study, Aspiration, Regurgitation, Acid Reflux
- Medical subject headings
- Deglutition Disorders, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal Volunteers | Patients older than 55 years of age with no history of voice, swallowing, reflux, or progressive neurologic disease affecting the swallowing mechanism. | |
| Patients with Dysphagia | Patients older than 55 years of age with the following condition: Dysphagia (the sensation of swallowing difficulty), globus, gastroesophageal reflux, or any other condition requiring referral for a dynamic swallowing study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swallowing amplitude as measured on digital accelerometry.
Digital accelerometry is a non-invasive method of measuring swallowing efficiency. A surface sensor is taped to the skin over the region of the thyroid prominence. When the patient swallows, the sensors measures upward acceleration of the thyroid cartilage and a measurement of swallowing amplitude, a surrogate measure for swallowing efficiency, is obtained.
Measured: Measurement is made at the time of patient participation.
Secondary outcomes (1)
To evaluate swallowing efficiency.
Peak pharyngeal pressure, upper esophageal sphincter (UES) residual pressure, and UES relaxation time, all surrogate measure sof swallowing efficiency, will be measured using pharyngeal manometry.
Measured: Measurement is taken at the time of patient participation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionNov 2012
- Study completionNov 2012
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.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Belafsky, MD, Ph.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270204
- Sponsor's protocol ID
- 201018116
- Status last verified
- May 2017
- First submitted
- 16 Dec 2010
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Food Taste, Temperature, and Viscosity on Swallowing Efficiency
- ClinicalTrials.gov ID
- NCT01270204
- Acronym / sponsor ID
- 201018116
- Conditions
- Dysphagia
- Keywords
- Dysphagia, Swallowing Problems, Dynamic Fluoroscopic Swallow Study, Aspiration, Regurgitation, Acid Reflux
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 5 Jan 2011 (estimated)
- 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 purpose of this study is to evaluate the effect of taste on swallowing efficiency, to evaluate the effect of temperature on swallowing efficiency, and to evaluate the effect of viscosity on swallowing efficiency.
Detailed description
Swallowing problems (dysphagia) are encountered frequently in primary practice and in the hospital setting. The list of possible causes is large, ranging from strokes and neurological disease to complications of cancer treatment, acid reflux, and surgery. Many patients have a reduced ability to feel food and fluid (reduced sensation) within the throat (pharynx) and this leads to an inability to manipulate food and fluids in the correct manner. This can produce a variety of swallowing problems such as choking on foods and fluids, regurgitation, aspiration, weight loss, malnutrition and poor quality of life.
Treatment of dysphagia is largely directed at rehabilitation of muscle power and education about safe swallowing techniques or positioning that limits food and fluid from entering the airway. One of the most widely accepted treatments of dysphagia is to alter the texture of food. Most patients with dysphagia will have more difficulty swallowing thin liquids. By adding a thickener to the liquid, a food bolus becomes more cohesive, and is less likely to become aspirated. Various types of thickening products are available over-the-counter without a prescription. These thickening products are bland and currently have no flavor. We hypothesize that alterations in food taste (sweet, salty, etc…), viscosity, and temperature, will improve swallowing efficiency. The purpose of this investigation is to evaluate the effects of food taste, texture, and temperature on swallowing efficiency. The goal is to develop safer, better tasting food products and improve the quality of life in patients with disabling swallowing disorders.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Volunteers | – | –Patients older than 55 years of age with no history of voice, swallowing, reflux, or progressive neurologic disease affecting the swallowing mechanism. |
| Patients with Dysphagia | – | –Patients older than 55 years of age with the following condition: Dysphagia (the sensation of swallowing difficulty), globus, gastroesophageal reflux, or any other condition requiring referral for a dynamic swallowing study. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 40 dysphagic volunteers and 10 healthy volunteers
Key inclusion criteria (8 listed)
- Normal Volunteers:
- Patients with Dysphagia
Key exclusion criteria (6 listed)
- Patients unable to complete the administration of the full taste and viscosity protocol.
- Patients with profound dysphagia unable to safely consume the test solutions.
- Patients with known sensitivities or allergies to any of the test solutions.
- Patients who are prisoners.
- Patients have a history of diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Swallowing amplitude as measured on digital accelerometry.
Time frame: Measurement is made at the time of patient participation.
Digital accelerometry is a non-invasive method of measuring swallowing efficiency. A surface sensor is taped to the skin over the region of the thyroid prominence. When the patient swallows, the sensors measures upward acceleration of the thyroid cartilage and a measurement of swallowing amplitude, a surrogate measure for swallowing efficiency, is obtained.
1 secondary outcome
To evaluate swallowing efficiency.
Time frame: Measurement is taken at the time of patient participation.
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 30 May 2017.
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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.
Peter Belafsky, MD, Ph.D. principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia, run by University of California, Davis at 1 site in United States.
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 8 inclusion and 6 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 30 May 2017. 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 United States. 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?
Swallowing amplitude as measured on digital accelerometry. (time frame: Measurement is made at the time of patient participation.). 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 30 May 2017.