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Evaluation of Two Different Thickening Products in Patients With Dysphagia

Primary Purpose

Dysphagia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Thickenup
Thickenup Advance
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dysphagia focused on measuring Dysphagia, Thickening liquid, Thickening agent, Fluoroscopic swallow study, Aspiration, History of dysphagia, DSS, Age > 18, comprehensive DSS, informed consent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History of dysphagia necessitating a dynamic fluoroscopic swallow study
  • Age > 18 years
  • Ability to complete a comprehensive dynamic fluoroscopic swallow study
  • Ability to provide informed consent for study participation

Exclusion Criteria:

  • Age < 18 years
  • Pregnant women
  • Prisoner or other institutionalized individual
  • Cognitive disability precluding the ability to provide informed consent or complete a comprehensive swallow study

Sites / Locations

  • University of California Davis Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Thickenup

Arm Description

Outcomes

Primary Outcome Measures

Compare aspiration risk
Compare the prevalence of aspiration risk with TUA to the prevalence of aspiration risk with TU and thin liquid barium at the time the subject undergoes a fluoroscopic swallowing study

Secondary Outcome Measures

Full Information

First Posted
January 24, 2012
Last Updated
May 25, 2017
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT01651975
Brief Title
Evaluation of Two Different Thickening Products in Patients With Dysphagia
Official Title
Evaluation of Two Different Thickening Products in Patients With Dysphagia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Dysphagia is extremely common. The importance of providing adequate nutritional support to persons with dysphagia is the cornerstone to exceptional care. Diet modification with thickening agents is an essential aspect of this nutritional support. The purpose of this investigation is to compare the efficacy of a starch based (Thickenup or TU) to a gel based thickening agent (Thickenup Advance or TUA).
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. The investigators hypothesize that alterations in food taste (sweet, salty, etc…), viscosity will improve swallowing efficiency. The purpose of this investigation is to evaluate the effects of food taste, texture 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
Dysphagia, Thickening liquid, Thickening agent, Fluoroscopic swallow study, Aspiration, History of dysphagia, DSS, Age > 18, comprehensive DSS, informed consent

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thickenup
Arm Type
Other
Intervention Type
Dietary Supplement
Intervention Name(s)
Thickenup
Other Intervention Name(s)
Liquid E-Z-Paque, E-Z-Em, Inc.
Intervention Description
given two 1-cc boluses of liquid contrast agent (barium), one 3-cc of thin liquid contrast, one 3-cc of paste, one cookie with contrast, one 20-cc bolus of liquid contrast, and one 20-cc bolus of thin liquid contrast. The patients are then studied in the anterior/posterior view with one 1-cc, one 3-cc, and one 20-cc bolus of thin liquid barium 1-4. At the end of the protocol patients are routinely administered products with either starch or gel based thickener to evaluate the swallowing safety of the thickened agent. The protocol includes a 3-minute limitation on total fluoroscopy time to ensure clinician and patient safety.
Intervention Type
Dietary Supplement
Intervention Name(s)
Thickenup Advance
Other Intervention Name(s)
Liquid E-Z Paque, E-Z-EM, Inc
Intervention Description
given two 1-cc boluses of liquid contrast agent (barium), one 3-cc of thin liquid contrast, one 3-cc of paste, one cookie with contrast, one 20-cc bolus of liquid contrast, and one 20-cc bolus of thin liquid contrast. The patients are then studied in the anterior/posterior view with one 1-cc, one 3-cc, and one 20-cc bolus of thin liquid barium 1-4. At the end of the protocol patients are routinely administered products with either starch or gel based thickener to evaluate the swallowing safety of the thickened agent. The protocol includes a 3-minute limitation on total fluoroscopy time to ensure clinician and patient safety.
Primary Outcome Measure Information:
Title
Compare aspiration risk
Description
Compare the prevalence of aspiration risk with TUA to the prevalence of aspiration risk with TU and thin liquid barium at the time the subject undergoes a fluoroscopic swallowing study
Time Frame
Time of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of dysphagia necessitating a dynamic fluoroscopic swallow study Age > 18 years Ability to complete a comprehensive dynamic fluoroscopic swallow study Ability to provide informed consent for study participation Exclusion Criteria: Age < 18 years Pregnant women Prisoner or other institutionalized individual Cognitive disability precluding the ability to provide informed consent or complete a comprehensive swallow study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Belafsky, MD, Ph.D.
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

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Evaluation of Two Different Thickening Products in Patients With Dysphagia

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