Phenylalanine Requirements in Healthy Pregnant Women
Dietary Phenylalanine Requirements During Different Stages of Gestation in Healthy Pregnant Women
1 other identifier
interventional
23
1 country
1
Brief Summary
Phenylalanine is an essential amino acid that people need to obtain in their diets. Amino acids are the building blocks for protein, which is required to form tissues in the body. It is well known that pregnant women require more protein in their diets, but the exact amount for each amino acid is undetermined. To find out how much of phenylalanine pregnant women require, the investigators plan to study pregnant women in early and late gestation with a modern minimally invasive technique.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pregnancy
Started Jan 2016
Longer than P75 for not_applicable pregnancy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedFirst Posted
Study publicly available on registry
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2019
CompletedNovember 14, 2019
November 1, 2019
2.4 years
November 30, 2015
November 12, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
13C Phenylalanine Oxidation
Urine, breath and a single blood sample will be collected during the study to measure the rate of oxidation of 13C phenylalanine.
8 hours
Study Arms (1)
Experimental: phenylalanine intake
OTHERDietary supplement: phenylalanine intake
Interventions
Oral consumption of eight hourly experimental meals- Includes 4 tracer-free experimental meals containing a mixture of free amino acids, calories from a flavored liquid and protein free cookies and 4- labeled amino acid experimental meals.
Eligibility Criteria
You may qualify if:
- over the age of twenty
- under the age of forty
- in overall good health
- pregnant with a single child
You may not qualify if:
- Be under the age of twenty
- Be over the age of forty
- Be pregnant with more than one child
- Have a history of cardiovascular disease, endocrine disorders, or metabolic disorders
- Have recently lost a substantial amount of weight
- Delivered a baby in the last 18 months
- Be substance dependent
- Be allergic to eggs
- Have severe nausea through the pregnancy
- Have gestational diabetes
- Have a history of spontaneous abortions
- Have had an unhealthy pre-pregnancy body mass index
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BC Children's Hospital Research Institute, University of British Columbia
Vancouver, British Columbia, V5Z4H4, Canada
Related Publications (1)
Ennis MA, Rasmussen BF, Lim K, Ball RO, Pencharz PB, Courtney-Martin G, Elango R. Dietary phenylalanine requirements during early and late gestation in healthy pregnant women. Am J Clin Nutr. 2020 Feb 1;111(2):351-359. doi: 10.1093/ajcn/nqz288.
PMID: 31758682DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Rajavel Elango, Ph.D.
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
November 30, 2015
First Posted
February 1, 2016
Study Start
January 1, 2016
Primary Completion
May 30, 2018
Study Completion
October 30, 2019
Last Updated
November 14, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share