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The Effect of Food Taste, Temperature, and Viscosity on Swallowing Efficiency

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ClinicalTrials.gov Identifier: NCT01270204
Recruitment Status : Completed
First Posted : January 5, 2011
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date December 16, 2010
First Posted Date January 5, 2011
Last Update Posted Date May 30, 2017
Study Start Date January 2011
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 22, 2013)
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.
Original Primary Outcome Measures
 (submitted: January 3, 2011)
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 amplitued, a surrogate measure for swallowing efficiency, is obtained.
Change History Complete list of historical versions of study NCT01270204 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 22, 2013)
To evaluate swallowing efficiency. [ Time Frame: Measurement is taken at the time of patient participation. ]
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.
Original Secondary Outcome Measures
 (submitted: January 3, 2011)
To evaluate swallowing efficiency. [ Time Frame: Measurement is taken at the time of patient participation. ]
Peak pharyngeal pressure, upper esophageal sphincter (UES) residualpressure, and UES relaxation time, all surrogate measure sof swallowing efficiency, will be measured using pharyngeal manometry.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Effect of Food Taste, Temperature, and Viscosity on Swallowing Efficiency
Official Title The Effect of Food Taste, Temperature, and Viscosity on Swallowing Efficiency
Brief 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.
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 Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 40 dysphagic volunteers and 10 healthy volunteers
Condition Dysphagia
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 22, 2013)
1
Original Estimated Enrollment
 (submitted: January 3, 2011)
50
Actual Study Completion Date November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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:

  1. Patients unable to complete the administration of the full taste and viscosity protocol.
  2. Patients with profound dysphagia unable to safely consume the test solutions.
  3. Patients with known sensitivities or allergies to any of the test solutions.
  4. Patients who are prisoners.
  5. Patients have a history of diabetes.
  6. Patients who are unable to follow the simple instructions to swallow the test solutions on instruction and answer the questionnaire.
Sex/Gender
Sexes Eligible for Study: All
Ages 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01270204
Other Study ID Numbers 201018116
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of California, Davis
Study Sponsor University of California, Davis
Collaborators Not Provided
Investigators
Principal Investigator: Peter Belafsky, MD, Ph.D. University of California, Davis
PRS Account University of California, Davis
Verification Date May 2017