Protein Requirements for Phenylketonuria

This trial aims to determine the appropriate protein intake for adults with Phenylketonuria (PKU), a condition where the body cannot properly break down a specific protein component. Researchers will use a special test diet and a safe, nonradioactive substance to measure protein processing in participants. It is designed for adults diagnosed with PKU who have undergone genetic testing. The trial excludes individuals with recent weight loss, ongoing illnesses, or certain medical devices. As an unphased trial, it offers participants a unique opportunity to contribute to valuable research that could enhance dietary guidelines for PKU.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

Research has shown that dietary treatments for Phenylketonuria (PKU) are generally easy to manage. One study found that people with PKU preferred a diet called GMP over another option, and importantly, they did not experience any adverse reactions. This suggests that the diets used to manage PKU are safe and typically do not cause negative side effects. Since this trial is in a "Not Applicable" phase, the study focuses on understanding dietary needs rather than testing new, unproven treatments. Therefore, the diet used should be safe for participants, as it relies on existing knowledge about managing PKU with diet.¹²³⁴⁵

Most treatments for phenylketonuria (PKU) involve a strict diet low in phenylalanine, often supplemented with medical foods or amino acid mixtures. However, this new test diet is unique because it incorporates an amino acid tracer using an oral stable nonradioactive isotope. This approach allows for precise tracking of protein metabolism in individuals with PKU, potentially providing more personalized dietary recommendations. Researchers are excited because this could lead to more effective and tailored dietary plans, improving the quality of life for those managing PKU.

Research has shown that medical nutrition therapy (MNT), which involves a diet low in phenylalanine (Phe) and includes special protein substitutes, effectively manages phenylketonuria (PKU). This is the primary treatment for PKU and prevents high Phe levels in the blood. Maintaining low Phe levels is crucial to avoid health problems in individuals with PKU. Studies have found that adhering to a Phe-restricted diet is essential for adults with this condition to stay healthy. Despite some challenges, this diet is key to effectively managing PKU. Participants in this trial will receive a test diet and an oral stable nonradioactive isotope to further study protein requirements in adults with PKU.¹³⁶⁷⁸