- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01270204
The Effect of Food Taste, Temperature, and Viscosity on Swallowing Efficiency
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Sacramento, California, United States, 95817
- UC Davis Department of Otolaryngology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Normal Volunteers
Patients older than 55 years of age with no history of voice, swallowing, reflux, or progressive neurologic disease affecting the swallowing mechanism.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Swallowing amplitude as measured on digital accelerometry.
Time Frame: Measurement is made at the time of patient participation.
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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.
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Measurement is made at the time of patient participation.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate swallowing efficiency.
Time Frame: Measurement is taken at the time of patient participation.
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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.
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Measurement is taken at the time of patient participation.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201018116
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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