Uptake kinetics of dietary phenylalanine during continuous enteral feeding

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616000593437
• Date of registration: 06/05/2016
• Prospective Registration: No
• Primary sponsor: Prof Olav Rooyackers
• Public title: Uptake kinetics of dietary phenylalanine during continuous enteral feeding
• Scientific title: Uptake kinetics of dietary 13C-phenylalanine during continuous enteral feeding in healthy subjects
• Date of first enrolment: 24/04/2016
• Target sample size: 10
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12616000593437.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Pharmacokinetics;
• Phase: Not Applicable

Countries of recruitment

Sweden

Contacts

• Name: Prof Olav Rooyackers

• Name: Prof Olav Rooyackers

Key inclusion & exclusion criteria

Inclusion criteria: Healthy adults
Exclusion criteria: Nutritional/metabolic disease, serious organ dysfunction

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Diet and Nutrition - Other diet and nutrition disorders

Enteral feeding;
Enteral feeding

Intervention(s)

During development of a methodology for studying enteral nutrition in ICU patients (see trial ID ACTRN12614000476639) we studied a pilot group of ICU patients to determine uptake kinetics of dietary stable-isotope-labeled phenylalanine during continuous enteral feeding. Relevant findings were a high inter-individual variability of 13C-phenylalanine plasma enrichment and uncertain steady state condition after 6 hrs of feeding (unpublished data).

The objective of the current trial is to determine whether a steady state of 13C-phenylalanine isotopic enrichment in plasma is reached after 6, 8, 10 or 12 hrs of 13-C-phenylalanine administration simultaneous with continuous enteral feeding. Subjects are admitted on the evening before the tracer study and stay under observation throughout the experiment. A nasogastric feeding tube is placed and a continuous infusion of a commercially available complete nutrition formula, Fresubin (registered trademark) Original, is started at a dose corresponding to 100% of estimated energy requirement. After a 12 hr equilibration period, a cannula for blood sampling is placed in an artery. Ongoing continuous nutrition is supplemented with a continuous infusion of 13C-labeled phenylalanine for another 12 hrs. The 13C-phenylalanine dose is calculated to yield an isotopic enrichment of 30.8% of the total dietary phenylalanine content, i.e. feeding formula + tracer Blood samples are taken every 30 minutes for the remaining 12 hrs. Isotopic enrichment of 13C-phenylalanine in plasma is measured by gas chromatography-mass spectrometry.

Primary Outcome(s)

Plasma enrichment of 13C-phenylalanine[Every 30 minutes from 12 to 24 hours post commencement of continuous enteral feeding]

Secondary Outcome(s)

None[None]

Secondary ID(s)

none

Source(s) of Monetary Support

Regional Agreement on Medical Training and Clinical Research (ALF) between Stockholm County Council and Karolinska Institutet

Ethics review

Status: Approved
Approval date:
Contact:

Regionala etikprovningsnamnden i Stockholm