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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter Belafsky, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT01270204
First received: December 16, 2010
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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.


Condition
Dysphagia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Effect of Food Taste, Temperature, and Viscosity on Swallowing Efficiency

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Swallowing amplitude as measured on digital accelerometry. [ Time Frame: Measurement is made at the time of patient participation. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • To evaluate swallowing efficiency. [ Time Frame: Measurement is taken at the time of patient participation. ] [ Designated as safety issue: No ]
    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.


Enrollment: 1
Study Start Date: January 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
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.

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

40 dysphagic volunteers and 10 healthy volunteers

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01270204

Locations
United States, California
UC Davis Department of Otolaryngology
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Peter Belafsky, MD, Ph.D. University of California, Davis
  More Information

No publications provided

Responsible Party: Peter Belafsky, MD, Professor, University of California, Davis
ClinicalTrials.gov Identifier: NCT01270204     History of Changes
Other Study ID Numbers: 201018116
Study First Received: December 16, 2010
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Dysphagia
Swallowing Problems
Dynamic Fluoroscopic Swallow Study
Aspiration
Regurgitation
Acid Reflux

ClinicalTrials.gov processed this record on September 22, 2014