Simplified Diet Approach in Phenylketonuria

Phenylketonuria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02555579
• Other study ID #: 0451-15-EP
• Status: Completed
• Phase: N/A
• Start date: October 26, 2015
• Est. completion date: September 20, 2017

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 20, 2017
• Est. primary completion date: September 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Phenylketonuria
• Phenylketonurias

Intervention

Behavioral:
• Dietary Protein Counting and Free Fruits and Vegetables
Subjects will be educated on new simplified diet approach and phenylalanine levels will be monitored for 1 year, and will be compared to 12 months prior to study enrollment

Locations

Country	Name	City	State
United States	Children's Hospital & Medical Center	Omaha	Nebraska
United States	Monroe-Meyer Insititute	Omaha	Nebraska
United States	Nebraska Medicine, Midtown Health Center	Omaha	Nebraska
United States	Unversity of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic Control in Teens and Adults with PKU	phenylalanine levels	12 months
Secondary	attitudes towards simplified diet approach	qualitative data collection	12 months