Simplified Diet Approach in Phenylketonuria

NCT02555579 | Completed

• 1 other identifier: 0451-15-EP
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 4

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.

Conditions

Phenylketonuria

Outcome Measures

Primary Outcomes (1)

• Metabolic Control in Teens and Adults with PKU

  phenylalanine levels

  12 months

Secondary Outcomes (1)

• attitudes towards simplified diet approach

  12 months

Study Arms (1)

Dietary Protein Counting & Free Fruits & Vegetables

EXPERIMENTAL

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

Behavioral: Dietary Protein Counting and Free Fruits and Vegetables

Interventions

Dietary Protein Counting and Free Fruits and Vegetables BEHAVIORAL

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

Dietary Protein Counting & Free Fruits & Vegetables

Eligibility Criteria

• Age: 13 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive diagnosis of PKU
• Males and females \>13 year of age
• Currently on phenylalanine-restricted diet

You may not qualify if:

• Any woman planning, or becoming pregnant during study duration
• Any patient who starts Kuvan during the study, as Kuvan lowers phenylalanine levels in some patients.
• Any patient currently enrolled in other research studies (Prism 301/302 Protocol; Institutional Review Board Protocol # 376-13-FB)

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (4)

Monroe-Meyer Insititute

Omaha, Nebraska, 68106, United States

Location

Children's Hospital & Medical Center

Omaha, Nebraska, 68114, United States

Location

Nebraska Medicine, Midtown Health Center

Omaha, Nebraska, 68131, United States

Location

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Phenylketonurias

Interventions

Vegetables

Condition Hierarchy (Ancestors)

Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jill C Skrabal, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2015
• First Posted: September 21, 2015
• Study Start: October 26, 2015
• Primary Completion: September 20, 2017
• Study Completion: September 20, 2017
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

US (4)