Clinical Trial: GMP Drink for PKU Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Evaluating the Tolerance, Safety and Acceptability of PKU GMPro, a Whey Protein Derived Feed for the Dietary Management of Phenylketonuria in Children and Adults - a Pilot Trial

Brief Summary: This study will evaluate the safety, gastrointestinal (GI) tolerance, acceptability and compliance of a Glycomacropeptide-based protein substitute for patients with Phenylketonuria (PKU).

Detailed Summary:
Sponsor: Nutricia UK Ltd

Current Primary Outcome: Blood Phenylalanine (and other amino acids) [ Time Frame: 3 points throughout 28 days ]

Blood spot test


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Gastro-intestinal tolerance questionaire [ Time Frame: 12/31 days ]
    Questionaire detailing any GI symptoms, severity and change from usual
  • Product compliance questionaire [ Time Frame: 31 days ]
    Breif questionaire on amounts offered and amounts actually consumed, compared to recomended amount.
  • Product acceptability questionnaire [ Time Frame: 2/31 days ]
    Breif tick-box questionaire on overal liking and acceptability of product
  • Patient reproted nutrient intake (3 day food diaries) [ Time Frame: 6/31 days ]
    3 day food diaries, subsequently analysed in dietary software.
  • Pateint-reported appetite (visual analogue scale) [ Time Frame: 6/31 days ]
    Measures of overal appetite and satiety via visual analouge scale
  • Antropometry (hieight and weight) [ Time Frame: 2/31 days ]
    Measurements of height and weight at baseline and end of study
  • Safety (Adverse events reporting) [ Time Frame: 31 days ]
    Reporting of adverse events throughout study


Original Secondary Outcome: Same as current

Information By: Nutricia UK Ltd

Dates:
Date Received: August 8, 2016
Date Started: July 2016
Date Completion: August 2018
Last Updated: September 22, 2016
Last Verified: September 2016