Clinical Trial: Evaluation of Two Different Thickening Products in Patients With Dysphagia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of Two Different Thickening Products in Patients With Dysphagia

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 Summary:

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.


Sponsor: University of California, Davis

Current Primary Outcome: Compare aspiration risk [ Time Frame: Time of intervention ]

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


Original Primary Outcome: Compare aspiration risk [ Time Frame: Time of intervention ]

Compare the prevalance 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


Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of California, Davis

Dates:
Date Received: January 24, 2012
Date Started: November 2009
Date Completion:
Last Updated: April 22, 2013
Last Verified: April 2013