Evaluation of Two Different Thickening Products in Patients With Dysphagia

NCT ID: NCT01651975

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-04-30

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.

Conditions

Dysphagia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Thickenup

Group Type: OTHER

Thickenup

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Liquid E-Z-Paque; E-Z-Em, Inc.; Liquid E-Z Paque; E-Z-EM, Inc

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Belafsky, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California Davis Medical Center

Sacramento, California, United States

Countries

United States

Other Identifiers

200917127

Identifier Type: -

Identifier Source: org_study_id