Protein Requirements in Adults With Phenylketonuria (PKU)

NCT ID: NCT03939052

Last Updated: 2024-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-19

Study Completion Date

2023-01-13

Brief Summary

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Phenylketonuria (PKU) is an inherited inborn error of phenylalanine (PHE) metabolism caused by decreased activity of phenylalanine hydroxylase (PAH) enzyme. Therefore, PHE accumulates in plasma leading to mental problems. Treatment is a phenylalanine-restricted diet with sufficient protein. However, the optimum protein requirements are still unknown and compliance with diet is not satisfactory in PKU adults. A Previously established technique called indicator amino acid oxidation (IAAO) will be used to determine protein requirements from amino acid based formula vs. glycomacropeptide (GMP) in adults with PKU (≥ 19y). This study will help treat adults with enough protein ensuring maintenance of health.

Detailed Description

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Conditions

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Phenylketonuria

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Protein intake

Free amino acids vs. Glycomacropeptide (GMP)

Group Type EXPERIMENTAL

Free amino acids intake

Intervention Type DIETARY_SUPPLEMENT

Oral consumption of eight hourly experimental meals- -4 tracer free experimental meals containing a mixture of free amino acids and calories from protein free flavoured liquid, protein free cookies and corn oil -4 isotopically labeled experimental meals. The same protocol will be repeated with glycomacropeptide (GMP).

Interventions

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Free amino acids intake

Oral consumption of eight hourly experimental meals- -4 tracer free experimental meals containing a mixture of free amino acids and calories from protein free flavoured liquid, protein free cookies and corn oil -4 isotopically labeled experimental meals. The same protocol will be repeated with glycomacropeptide (GMP).

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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glycomacropeptide (GMP) intake

Eligibility Criteria

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Inclusion Criteria

-Adults more than 19 years of age who are diagnosed with PKU and clinically stable with no acute illness

Exclusion Criteria

* Adults with PKU under age 19 year
* Adults diagnosed with PKU but are currently ill with a fever or cold
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vitaflo International, Ltd

INDUSTRY

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Rajavel Elango, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rajavel Elango, PhD

Role: PRINCIPAL_INVESTIGATOR

BC Children's Hospital Research Institute, University of British Columbia

Sandra Sirrs, MD

Role: STUDY_CHAIR

University of British Columbia

Sylvia Stockler, MD

Role: STUDY_CHAIR

University of British Columbia

Locations

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BC Children's Hospital Research Institute, University of British Columbia

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H18-03464

Identifier Type: -

Identifier Source: org_study_id

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