Clinical trial NCT02555579: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phenylketonuria
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2015-09-21
Enrollment: 33
Sex: ALL
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Metabolic Control in Teens and Adults with PKU
timeFrame: 12 months
Secondary outcomes:
measure: attitudes towards simplified diet approach
timeFrame: 12 months
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Monroe-Meyer Insititute
state: Nebraska
city: Omaha
country: United States
facility: Children's Hospital & Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Medicine, Midtown Health Center
state: Nebraska
city: Omaha
country: United States
facility: Unversity of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Jill C Skrabal, PhD
role: PRINCIPAL_INVESTIGATOR
References: