NCT04326322

Brief Summary

The current recommendations for dietary amino acid intake in pregnant women are based on calculations from requirements of adult men. The study aims to determine methionine requirements during early (11-20 weeks) and late (31-38 weeks) stages of pregnancy. Methionine, an essential amino acid (building block of body protein), is necessary for protein synthesis and for DNA related cellular functions. A non-invasive, novel method based on different diets, stable isotopes (the safe kind) and simple breath collection will be used. This method has recently been used by our laboratory to study other amino acids during pregnancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

September 14, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

2.8 years

First QC Date

March 26, 2020

Last Update Submit

February 9, 2026

Conditions

Pregnancy Related

Keywords

nutritionmethioninesulfur amino acidsstable isotope

Outcome Measures

Primary Outcomes (1)

  • The rate of oxidation of 13C phenylalanine.

    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)

Methionine 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: Methionine Intake

Interventions

Methionine IntakeDIETARY_SUPPLEMENT

Intakes will be randomly chosen from a list of 7 doses of methionine. Each intake will will be repeated approximately 5 times.

Methionine Intake

Eligibility Criteria

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

You may qualify if:

  • Women who are 20-40 years of age. This includes women of reproductive age who have a low relative risk ratio of maternal or neonatal morbidities.
  • Women pregnant with a singleton pregnancy.
  • Women who are 11-20 or 31-40 weeks pregnant.
  • In apparently good health. Subjects must not have pre-existing health conditions.

You may not qualify if:

  • Women who are not pregnant or who are pregnant with more than one fetus.
  • Women who were pregnant in the 6 months before the current pregnancy
  • Women with history of spontaneous abortion (within the last 6 months) or pre-term birth
  • Women who are younger than 20 years of age and older than 40 years of age.
  • Women with a metabolic, neurological, genetic or immune disorder likely to affect nutritional requirements or overall body metabolism.
  • \. Women who depend on medication that affects normal metabolism. 6. Women experiencing severe nausea, food avoidance or vomiting throughout their pregnancy.
  • \. Women allergic to eggs or egg protein. 8. Women classified as underweight (\<18.5 kg/m2), overweight (25-30 kg/m2) or obese (\>30 kg/m2).
  • \. Women smoking cigarettes, taking illicit drugs, or consuming alcohol regularly during their pregnancy.
  • \. Women who do not take a prenatal vitamin for the duration of their study period.
  • \. Women who have lost weight (approximately 1.5kg or more) during their current pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Children's Hospital Research Institute

Vancouver, British Columbia, V5Z4H4, Canada

Location

Related Publications (1)

  • Scherbinsky K, Rasmussen BF, Li B, Kong D, Ball RO, Pencharz PB, Courtney-Martin G, Elango R. Total sulfur amino acid requirements are higher during late gestation compared with early gestation in healthy Canadian pregnancies in a repeated-measures trial. Am J Clin Nutr. 2024 Oct;120(4):973-983. doi: 10.1016/j.ajcnut.2024.07.034. Epub 2024 Aug 10.

    PMID: 39128498DERIVED

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

March 26, 2020

First Posted

March 30, 2020

Study Start

September 14, 2020

Primary Completion

June 21, 2023

Study Completion

June 1, 2024

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)