NCT03409939

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2020

Completed
Last Updated

September 23, 2020

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

January 18, 2018

Last Update Submit

September 22, 2020

Conditions

Keywords

nutritionphenylalaninetyrosinestable isotope

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

EXPERIMENTAL

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.

Dietary Supplement: Aromatic Amino Acid Intake

Interventions

Aromatic Amino Acid IntakeDIETARY_SUPPLEMENT

Intakes will be randomly chosen from a list of 8 doses of aromatic amino acids. Each intake will will be repeated approximately 4 times.

Aromatic Amino Acid Intake

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

Study Officials

  • Rajavel Elango, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

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

Locations