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Simplified Diet Approach in Phenylketonuria

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Disease Information

Descriptive Information
Brief Title † Simplified Diet Approach in Phenylketonuria
Official Title † Use of Dietary Protein and Free Fruits and Vegetables to Improve Metabolic Control Among Teens and Adults With Phenylketonuria: A Mixed Methods Approach
Brief Summary This is a study to determine if a simplified protein counting system, including the free usage of fruits and vegetables low in phenylalanine, will improve the metabolic control in teens and adults with phenylketonuria (PKU). Anybody with a positive diagnosis of PKU, between the ages of 13-65 years will be invited to participate in this study. Subjects will be educated on the simplified system upon enrollment, and historical phenylalanine (Phe) levels will be used for comparison. Subjects will also be asked about their attitudes towards their current Phe counting system.
Detailed Description This is a study to determine if a simplified protein counting system, including the free usage of fruits and vegetables low in phenylalanine, will improve the metabolic control in teens and adults with phenylketonuria (PKU). Anybody with a positive diagnosis of PKU, between the ages of 13-65 years will be invited to participate in this study. Subjects will be educated on the simplified system upon enrollment, and historical phenylalanine (Phe) levels will be used for comparison. Subjects will also be asked about their attitudes towards their current Phe counting system. Upon enrollment, a 3-day food record and Phe levels over the past 12 months will be collected. Demographic information will be asked, as well as questions regarding their current Phe counting system. Patients will be educated on the new counting system, stressing 3 key principles: 1) free use of fruits and vegetables, low in protein, 2) protein counting as a simpler version of Phe counting, including reinforcement of label reading, and 3) daily use of PKU formula for enhanced nutrient and protein intake. Patients will be given written educational tools to reinforce this new method. At the end of the 12 months, subjects will be asked to provide a 3-day food record, and questions will be asked about their attitudes toward the use of the new simplified system. Phenylalanine levels from the 12-month study period will be used to compare with historical data.
Study Phase N/A
Study Type † Interventional
Study Design † Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † Metabolic Control in Teens and Adults with PKU
Secondary Outcome Measure † attitudes towards simplified diet approach
Condition † Phenylketonuria
Intervention † BehavioralDietary Protein Counting and Free Fruits and Vegetables
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Behavioral
Estimated Enrollment † 30
Start Date † September 2015
Completion Date May 2017
Primary Completion Date December 2016
Eligibility Criteria † Inclusion Criteria: 1. Positive diagnosis of PKU 2. Males and females >13 year of age 3. Currently on phenylalanine-restricted diet Exclusion Criteria: 1. Any woman planning, or becoming pregnant during study duration 2. Any patient who starts Kuvan during the study, as Kuvan lowers phenylalanine levels in some patients. 3. Any patient currently enrolled in other research studies (Prism 301/302 Protocol; Institutional Review Board Protocol # 376-13-FB)
Gender Both
Ages 13 Years - 65 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries †
Administrative Information
NCT ID † NCT02555579
Organization ID 451-15-EP
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † University of Nebraska
Collaborators ††
Investigators † : ,
Information Provided By
Verification Date September 2015
First Received Date † September 17, 2015
Last Updated Date September 18, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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