Pregnancy RelatedNCT04326322
Methionine Requirements During Healthy Human Pregnancy
A study testing Methionine Intake in people with Pregnancy Related, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Methionine Intake
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteCanada
- Study dates
- 14 Sep 2020to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 5. Women who depend on medication that affects normal metabolism. 6. Women experiencing severe nausea, food avoidance or vomiting throughout their pregnancy.
Show all 10Show fewer
- 7. 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).
- 9. Women smoking cigarettes, taking illicit drugs, or consuming alcohol regularly during their pregnancy.
- 10. Women who do not take a prenatal vitamin for the duration of their study period.
- 11. Women who have lost weight (approximately 1.5kg or more) during their current pregnancy.
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Children's Hospital Research Institute
Vancouver, British Columbia, V5Z4H4
About this study
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.
Read the detailed description
Pre-study day protocol:
Participants will be asked to meet for a brief (1 hour) pre-study assessment in preparation for the study day. Participants' eligibility will be assessed during this time. Subjects will arrive at the British Columbia Children's Hospital Research Institute's Clinical Research and Evaluation Unit (CREU) having fasted overnight (at least 8 hours since last caloric intake; no morning exercise, and assisted transportation to minimize stress). The consent form will be thoroughly explained, with the subject instructed to stop and ask questions at any point in which they are confused or uncomfortable. If the participants are willing to participate, verbal consent and a signature will be obtained. On this day, participants will fill out a questionnaire, and the following measurements will be taken: height (Harpenden Stadiometer; Holtain Limited, UK) and weight (electric scale; HealthOMeter Professional, Sunbeam Products, Inc.), bioelectrical impedance analysis (BIA; Q4 Bioimpedance Analyzer, RJL Systems, MI), 3 site skinfold (Harpenden Calipers; Baty International, UK), blood glucose (One Touch Ultra, LifeScan, Inc.), and resting energy expenditure (REE; Vmax Encore, Viasys, CA). The REE describes the caloric requirement for vital function in the absence of physical exertion. This value will be used to calculate the total energy content of the experimental diets in order to ensure that the specific caloric needs of each participant will be met. Blood glucose will be assessed for gestational diabetes mellitus (GDM; fasting plasma glucose level of 5.3 mmol/L indicative of GDM). Skinfold and BIA measurements will be collected to determine maternal fat and fat free mass.
Study day protocol:
Healthy pregnant women (20-40 y) who have consented and participated in the pre-study day will be studied at two stages of gestation (n=15/stage) over a range of test methionine intakes (ranging from 0-40mg/kg/day). At the beginning and end of the day a urine dipstick test will be performed. Each study day will be separated by a week and will receive a different, random methionine test intake. On the day of the study, participants will come in fasted at ~8 am for a total of eight hours. They will receive eight hourly meals, which represent 1/12 of their balanced nutritional need for the day. The meals consist of an orange flavoured shake with egg protein composition, balanced with sufficient carbohydrates and lipids. A tracer amino acid (L-[1-13C] phenylalanine) will be provided with the test meals to assess oxidation of the tracer to 13CO2 (13C- carbon dioxide) in breath in response to the test/limiting amino acid (methionine). Open-circuit indirect calorimetry will be performed until 5 steady state data points will be obtained for the measurement of VCO2 (Carbon Dioxide Output; Vmax Encore, Viasys, CA). This technique, called the indicator amino acid oxidation method, is a novel, non-invasive and completely safe approach especially in pregnancy.
Throughout the 8-hour study period biological samples (breath, urine, blood) will be collected and analyzed for 13CO2 content and sulfur amino acid metabolites.
- Conditions
- Pregnancy Related
- Being tested
- Methionine Intake
- Keywords
- nutrition, methionine, sulfur amino acids, stable isotope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Methionine Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start14 Sep 2020
- Primary completion21 Jun 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajavel Elango, PhD, University of British Columbia
- Investigators
- Rajavel Elango, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326322
- Sponsor's protocol ID
- H20-00383
- Status last verified
- Feb 2026
- First submitted
- 26 Mar 2020
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scherbinsky K, Rasmussen BF, Li B, Kong D, Ball RO, Pencharz PB, Courtney-Martin G, Elango R. Methionine Requirements in Early and Late Stages of Healthy Canadian Pregnancies in the Presence of Cysteine Determined Using the Indicator Amino Acid Oxidation Method. J Nutr. 2026 Jul 25;156(9):101748. doi: 10.1016/j.tjnut.2026.101748. Online ahead of print.
PubMed 42501824Scherbinsky 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.
PubMed 39128498
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methionine Requirements During Healthy Human Pregnancy
- ClinicalTrials.gov ID
- NCT04326322
- Acronym / sponsor ID
- H20-00383
- Conditions
- Pregnancy Related
- Keywords
- nutrition, methionine, sulfur amino acids, stable isotope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pre-study day protocol:
Participants will be asked to meet for a brief (1 hour) pre-study assessment in preparation for the study day. Participants' eligibility will be assessed during this time. Subjects will arrive at the British Columbia Children's Hospital Research Institute's Clinical Research and Evaluation Unit (CREU) having fasted overnight (at least 8 hours since last caloric intake; no morning exercise, and assisted transportation to minimize stress). The consent form will be thoroughly explained, with the subject instructed to stop and ask questions at any point in which they are confused or uncomfortable. If the participants are willing to participate, verbal consent and a signature will be obtained. On this day, participants will fill out a questionnaire, and the following measurements will be taken: height (Harpenden Stadiometer; Holtain Limited, UK) and weight (electric scale; HealthOMeter Professional, Sunbeam Products, Inc.), bioelectrical impedance analysis (BIA; Q4 Bioimpedance Analyzer, RJL Systems, MI), 3 site skinfold (Harpenden Calipers; Baty International, UK), blood glucose (One Touch Ultra, LifeScan, Inc.), and resting energy expenditure (REE; Vmax Encore, Viasys, CA). The REE describes the caloric requirement for vital function in the absence of physical exertion. This value will be used to calculate the total energy content of the experimental diets in order to ensure that the specific caloric needs of each participant will be met. Blood glucose will be assessed for gestational diabetes mellitus (GDM; fasting plasma glucose level of 5.3 mmol/L indicative of GDM). Skinfold and BIA measurements will be collected to determine maternal fat and fat free mass.
Study day protocol:
Healthy pregnant women (20-40 y) who have consented and participated in the pre-study day will be studied at two stages of gestation (n=15/stage) over a range of test methionine intakes (ranging from 0-40mg/kg/day). At the beginning and end of the day a urine dipstick test will be performed. Each study day will be separated by a week and will receive a different, random methionine test intake. On the day of the study, participants will come in fasted at ~8 am for a total of eight hours. They will receive eight hourly meals, which represent 1/12 of their balanced nutritional need for the day. The meals consist of an orange flavoured shake with egg protein composition, balanced with sufficient carbohydrates and lipids. A tracer amino acid (L-[1-13C] phenylalanine) will be provided with the test meals to assess oxidation of the tracer to 13CO2 (13C- carbon dioxide) in breath in response to the test/limiting amino acid (methionine). Open-circuit indirect calorimetry will be performed until 5 steady state data points will be obtained for the measurement of VCO2 (Carbon Dioxide Output; Vmax Encore, Viasys, CA). This technique, called the indicator amino acid oxidation method, is a novel, non-invasive and completely safe approach especially in pregnancy.
Throughout the 8-hour study period biological samples (breath, urine, blood) will be collected and analyzed for 13CO2 content and sulfur amino acid metabolites.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methionine Intake | Experimental | Dietary Supplement: Methionine IntakeOral 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methionine IntakeIntakes will be randomly chosen from a list of 7 doses of methionine. Each intake will will be repeated approximately 5 times. | Dietary supplement | Methionine Intake |
Primary outcome
The rate of oxidation of 13C phenylalanine.
Time frame: 8 hours
Urine, breath and a single blood sample will be collected during the study to measure the rate of oxidation of 13C phenylalanine.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Derived from this study: PubMed 42501824Scherbinsky K, Rasmussen BF, Li B, Kong D, Ball RO, Pencharz PB, Courtney-Martin G, Elango R. Methionine Requirements in Early and Late Stages of Healthy Canadian Pregnancies in the Presence of Cysteine Determined Using the Indicator Amino Acid Oxidation Method. J Nutr. 2026 Jul 25;156(9):101748. doi: 10.1016/j.tjnut.2026.101748. Online ahead of print.
- Derived from this study: PubMed 39128498Scherbinsky 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajavel Elango, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methionine Intake in people with Pregnancy Related, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of oxidation of 13C phenylalanine. (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04326322, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.