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 ]
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