Evaluation of Two Different Thickening Products in Patients With Dysphagia

Dysphagia Clinical Trial

Official title:

Evaluation of Two Different Thickening Products in Patients With Dysphagia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01651975
• Other study ID #: 200917127
• Status: Completed
• Phase: Phase 4
• First received: January 24, 2012
• Last updated: May 25, 2017
• Start date: November 2009
• Est. completion date: April 2011

Study information

• Verified date: May 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of California Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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