Determining Total Aromatic Amino Acid Requirements in Pregnant Women
Determining Dietary Total Aromatic Amino Acid (Phenylalanine and Tyrosine) Requirements During Different Stages of Gestation in Healthy Pregnant Women
1 other identifier
interventional
19
1 country
1
Brief Summary
Phenylalanine and tyrosine are aromatic amino acids that people need to obtain in their diets. Amino acids are the building blocks for protein, are are therefore 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 and tyrosine 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
Started Feb 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2018
CompletedFirst Posted
Study publicly available on registry
January 24, 2018
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2020
CompletedSeptember 23, 2020
September 1, 2020
2 years
January 18, 2018
September 22, 2020
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)
Aromatic Amino Acid Intake
EXPERIMENTALOral 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.
Interventions
Intakes will be randomly chosen from a list of 8 doses of aromatic amino acids. Each intake will will be repeated approximately 4 times.
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
- Have been pregnant with another child 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)
Clinical Research and Evaluation Unit
Vancouver, British Columbia, V6H3N1, Canada
Study Officials
- PRINCIPAL INVESTIGATOR
Rajavel Elango, PhD
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
- Principal Investigator
Study Record Dates
First Submitted
January 18, 2018
First Posted
January 24, 2018
Study Start
February 1, 2018
Primary Completion
January 17, 2020
Study Completion
January 17, 2020
Last Updated
September 23, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share