An exploratory matched case-control study to measure blood nutrient levels of adult PKU patients on a protein substitute.

Completed

• Conditions: Phenylketonuria / PKU; 10021605

• Registration Number: NL-OMON50188
• Lead Sponsor: utricia Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2024-03-08
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1. Age >=18 years
2. Written informed consent
3. Same age- (±3 years) and sex as an included PKU subject

Exclusion Criteria

1. For women: Currently pregnant or lactating
2. Current psychiatric disorders
3. Current Substance Use Disorders (as described in DSM V)
4. Current use of psychotropic and/or inotropic medication (exclusion due to
inotropic medication use only if main goal or prescription is to alter the
contractability of the heart) six weeks prior to V1.
5. Omega-3, antioxidant, (multi)vitamin (other than vitamin D) and/or
(multi)mineral supplement use within six weeks prior to entry in the study (for
NCRU: prior to V1). Vitamin D supplementation is allowed
6. Severe hepatic, thyroid or renal dysfunction
7. No acute illnesses like flu, diarrhea, or vomiting (subjects should be
symptom free for a week prior to V1)
8. Participation in any other clinical intervention studies involving test
products concomitantly or within six weeks prior to entry into the study. (for
NCRU: prior to V1).
9. Other family members taking part in this study
10. Any condition (e.g. celiac disease, anorexia, bulimia, gastrointestinal
tract disorders) or special diet (e.g. vegan or vegetarian diet, professional
athletes, people actively aiming to lose weight) that effects the metabolism
and/or normal dietary pattern/intake
11. A first or second degree relative with inborn errors of metabolism
12. Living together with someone with inborn errors of metabolism (e.g.
partner, spouse or roommate).
13. NCRU specific: Employees of Nutricia Research and/or partners, parents,
children and brothers/sisters of employees

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main outcome parameter in this study is the blood nutritional status.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The other outcome parameters in this study are:<br /><br>• Phe/Tyr Ratio [µmol/L]<br /><br>• Nutrient intake three-day diet diary will be recorded by the subjects on<br /><br>three consecutive days (2 weekdays and 1 day in the weekend), including product<br /><br>or supplement use (see Table 2). Nutrient intake will be calculated at a local<br /><br>level (e.g. dietician at site) using validated software packages.<br /><br>• Electronic questionnaire to assess subjective cognitive wellbeing<br /><br>(FACT-Cognitive Function (Version 3)) </p><br>