PKU Low Calorie Drink Study
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|ClinicalTrials.gov Identifier: NCT04272736|
Recruitment Status : Not yet recruiting
First Posted : February 17, 2020
Last Update Posted : February 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Phenylketonurias Hyperphenylalaninaemia||Dietary Supplement: Low calorie protein substitute||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluating the Compliance, Acceptability, Safety and Tolerance of a Lower Calorie Protein Substitute for the Dietary Management of Phenylketonuria in Children and Adults - a Pilot Study|
|Estimated Study Start Date :||September 1, 2020|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: Low calorie protein substitute
Single arm designed, 3 day baseline, 28 day on the lower calorie amino acid based liquid protein substitute.
Dietary Supplement: Low calorie protein substitute
The evaluated dietary supplement is a lower calorie amino acid based liquid protein substitute designed for patients with PKU.
- Compliance [ Time Frame: Daily for 31 days ]Questionnaire on amounts offered and amounts actually consumed, compared to recommended amount. Amounts (values) are recorded
- Acceptability: Tick-box questionnaire [ Time Frame: Recorded at baseline and end of intervetnion (day 31) ]Tick-box questionnaire on overall liking and acceptability of product (ie dislike a lot, dislike moderately, neutral, like moderately, like a lot)
- Blood phenylalanine and other amino acid levels [ Time Frame: Recorded at baselien and end of intervention (day 31) ]Blood spot test.
- Gastro-intestinal tolerance [ Time Frame: recorded at baseline, beginning of intervention and end of intervention(12 out of 31 days in total) ]Questionnaire detailing any GI symptoms, severity (none, mild, moderate, severe) and change from usual.
- Nutrient intake [ Time Frame: Recorded at basleine and end of intervention (day 31) ]24h dietary recall.
- Anthropometry [ Time Frame: Recorded at baseline and end of intervention (day 31) ]Measurements of height (m) and weight (kg) at baseline and end of study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04272736
|Contact: Gary Hubbard, PhDemail@example.com|