Evaluation of Two Different Thickening Products in Patients With Dysphagia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter Belafsky, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT01651975
First received: January 24, 2012
Last updated: April 22, 2013
Last verified: April 2013
  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:


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

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
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: 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 September 18, 2014