Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05958784
Status:
RECRUITING
Last Update Posted:
2023-07-25
First Post:
2023-07-05
Brief Title:
PKU Carriers Trial Pilot Study Impact on Cognition Mental Health Blood Pressure and Metabolism
Sponsor:
University of Guelph
Organization:
University of Guelph
Study Overview
Official Title:
A Pilot Study for the PKU Carriers Trial Evaluating the Impact of PKU Carrier Status on Cognition Mental Health Blood Pressure and L-phenylalanine Metabolism
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a clinical intervention pilotfeasibility study of PKU carriers cases and non-carriers controls Upon completing the informed consent process participants will complete baseline measures of chronic mental health prior to the intervention PHQ-9 GAD-7 BIS-Brief Participants will attend the Human Nutraceutical Research Unit HNRU at the University of Guelph fasted and first undergo baseline measures of cognition and acute mental health mood and provide samples or saliva urine and dried blood spots to evaluate phenylalanine Phe tyrosine Tyr and their metabolites PAH pathway functioning Participants will also complete a brief questionnaire which will include age sex ethnicity income weight and height measured using a stadiometer and calibrated weigh scale and confirmation that participants arrived to the lab fasted ie have only had water to drink and no other foodsbeverages prior to analyses Blood pressure will also be measured at baseline Following baseline tests participants will consume a pure L-Phe supplement dosed at 100 mgkg Blood pressure will be repeated at 1-hour post-L-Phe consumption Two-hours postprandial participants will repeat the cognitive tests and acute mental health mood assessment blood pressure measurement and provide follow-up saliva urine and dried blood spot samples Participants will also be asked to report any side effects they experienced with the L-Phe consumption
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None