Evaluation of Two Different Thickening Products in Patients With Dysphagia

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).

Study Overview

• Status: Completed
• Conditions: Dysphagia
• Intervention / Treatment: Dietary supplement: Thickenup; Dietary supplement: Thickenup Advance

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Time of intervention

Collaborators and Investigators

• Sponsor: University of California, Davis

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: January 24, 2012
• First Submitted That Met QC Criteria: July 26, 2012
• First Posted (Estimate): July 27, 2012

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 25, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Dysphagia; Aspiration; informed consent; Thickening liquid; Thickening agent; Fluoroscopic swallow study; History of dysphagia; DSS; Age > 18; comprehensive DSS
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: 200917127