Simplified Diet Approach in Phenylketonuria

NCT02555579 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2023-09-07

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Jill C Skrabal, PhD · University of Nebraska

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-26
Primary Completion
2017-09-20
Completion
2017-09-20

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02555579 on ClinicalTrials.gov