Evaluation of Two Different Thickening Products in Patients With Dysphagia

Phase 4

Completed

• Conditions: Dysphagia
• Interventions: Dietary Supplement: Thickenup; Dietary Supplement: Thickenup Advance

• Registration Number: NCT01651975
• Lead Sponsor: University of California, Davis

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 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 Timeline

• Study Start: 2009-11
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Study First Submitted: 2012-01-24
• Study First Submitted QC: 2012-07-26
• Study First Posted: 2012-07-27
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thickenup	Thickenup Advance	-
Thickenup	Thickenup	-

Primary Outcome Measures

Name	Time	Method
Compare aspiration risk	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

Trial Locations

Locations (1)

University of California Davis Medical Center; 🇺🇸 Sacramento, California, United States