Evaluation of Two Different Thickening Products in Patients With Dysphagia - Full Text View

Purpose

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).

Condition	Intervention	Phase
Dysphagia	Dietary Supplement: Thickenup Dietary Supplement: Thickenup Advance	Phase 4

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Evaluation of Two Different Thickening Products in Patients With Dysphagia

Resource links provided by NLM:

MedlinePlus related topics: Swallowing Disorders

U.S. FDA Resources

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

Primary Outcome Measures:

Compare aspiration risk [ Time Frame: Time of intervention ] [ Designated as safety issue: No ]
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

Enrollment:	100
Study Start Date:	November 2009
Study Completion Date:	April 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Thickenup	Dietary Supplement: Thickenup 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. Other Names: Liquid E-Z-Paque E-Z-Em, Inc. Dietary Supplement: Thickenup Advance 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. Other Names: Liquid E-Z Paque E-Z-EM, Inc

Arms

Assigned Interventions

Thickenup

Dietary Supplement: Thickenup

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.

Other Names:

Liquid E-Z-Paque
E-Z-Em, Inc.

Dietary Supplement: Thickenup Advance

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.

Other Names:

Liquid E-Z Paque
E-Z-EM, Inc

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651975

Locations

United States, California
University of California Davis Medical Center
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, Associate Professor, University of California, Davis
ClinicalTrials.gov Identifier:	NCT01651975 History of Changes
Other Study ID Numbers:	200917127
Study First Received:	January 24, 2012
Last Updated:	April 22, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Davis:

Dysphagia
Thickening liquid
Thickening agent
Fluoroscopic swallow study
Aspiration
History of dysphagia

fluoroscopic swallow study
DSS
Age > 18
comprehensive DSS
informed consent

Additional relevant MeSH terms:

Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases

Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on June 18, 2013