PregnancyNCT02669381
Phenylalanine Requirements in Healthy Pregnant Women
A study testing Phenylalanine intake in people with Pregnancy, run by University of British Columbia at 1 site in Canada.
Trial 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. 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
- What is being tested?
- Phenylalanine intake
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2016to 30 Oct 2019
- 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
- over the age of twenty
- under the age of forty
- in overall good health
- pregnant with a single child
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Children's Hospital Research Institute, University of British Columbia
Vancouver, British Columbia, V5Z4H4
About this study
Official title: Dietary Phenylalanine Requirements During Different Stages of Gestation in Healthy Pregnant Women
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.
Read the detailed description
The investigator's purpose is to determine the phenylalanine requirements in healthy pregnant women as part of a Master's Thesis project. The determined requirements can be taken into account when giving dietary recommendations, to ensure healthy pregnancies. The hypothesis is that the current recommendations for phenylalanine intake given to pregnant women are underestimated. The investigators also hypothesize that the phenylalanine requirements at early stages of pregnancy will be lower than the requirements towards the later stages of pregnancy.
Current dietary intake recommendations for phenylalanine are based on factorial (mathematical) calculations and do not account for requirement differences between early and late pregnancy. Static recommendations throughout all stages of pregnancy are not appropriate because of the multitude of adaptations the human body goes through during gestation. Whether phenylalanine requirements differ between different stages of gestation is unknown. In addition, phenylalanine is the precursor for tyrosine, which is a conditionally indispensable amino acid. Together they are referred to as the aromatic amino acids. The DRI gives a recommendation for total aromatic amino acids (TAA, phenylalanine + tyrosine) of 36 mg/kg/d during pregnancy. Since this study is the first interested in phenylalanine requirements during pregnancy, the investigators will determine the phenylalanine requirements in the presence of excess tyrosine (61 mg/kg/d) during pregnancy, similar to earlier studies.
The investigators will recruit healthy pregnant women aged 20 to 40 in their 13th-19th week of gestation or 33rd to 39th week of gestation. Once they get in contact with the lab, an initial visit (pre-study) will take place. Here, the participants will be measured for their eligibility and taken through the consent form. They have to participate in a pre-study for each stage of pregnancy, if they wish to participate in both stages. If they meet all the criteria and agree to participate, they will return for up to two study days per stage of 8 hours each. Therefore, if they are recruited during late pregnancy they are only able to participate in two study days in total. During these study days they will be fed protein shakes containing the stable isotope, and then oxidation of this isotope will be measured to determine a breakpoint (requirement) of phenylalanine. Breath samples, urine samples, and a small blood sample will be taken during the study day.
- Conditions
- Pregnancy
- Being tested
- Phenylalanine intake
- Keywords
- Phenylalanine, Direct Amino Acid Oxidation, Stable isotopes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenylalanine intakeDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: phenylalanine intake | Other | Dietary supplement: phenylalanine intake Receives: Dietary Supplement: Phenylalanine intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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 posted1 Feb 2016 (estimated)
- Study start1 Jan 2016
- Primary completion30 May 2018
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Rajavel Elango, PhD, University of British Columbia
- Investigators
- Rajavel Elango, Ph.D., Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669381
- Sponsor's protocol ID
- H15-02558
- Status last verified
- Nov 2019
- First submitted
- 30 Nov 2015
- Last updated
- 14 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31758682
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Phenylalanine Requirements During Different Stages of Gestation in Healthy Pregnant Women
- ClinicalTrials.gov ID
- NCT02669381
- Acronym / sponsor ID
- H15-02558
- Conditions
- Pregnancy
- Keywords
- Phenylalanine, Direct Amino Acid Oxidation, Stable isotopes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 1 Feb 2016 (estimated)
- 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.
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.
Detailed description
The investigator's purpose is to determine the phenylalanine requirements in healthy pregnant women as part of a Master's Thesis project. The determined requirements can be taken into account when giving dietary recommendations, to ensure healthy pregnancies. The hypothesis is that the current recommendations for phenylalanine intake given to pregnant women are underestimated. The investigators also hypothesize that the phenylalanine requirements at early stages of pregnancy will be lower than the requirements towards the later stages of pregnancy.
Current dietary intake recommendations for phenylalanine are based on factorial (mathematical) calculations and do not account for requirement differences between early and late pregnancy. Static recommendations throughout all stages of pregnancy are not appropriate because of the multitude of adaptations the human body goes through during gestation. Whether phenylalanine requirements differ between different stages of gestation is unknown. In addition, phenylalanine is the precursor for tyrosine, which is a conditionally indispensable amino acid. Together they are referred to as the aromatic amino acids. The DRI gives a recommendation for total aromatic amino acids (TAA, phenylalanine + tyrosine) of 36 mg/kg/d during pregnancy. Since this study is the first interested in phenylalanine requirements during pregnancy, the investigators will determine the phenylalanine requirements in the presence of excess tyrosine (61 mg/kg/d) during pregnancy, similar to earlier studies.
The investigators will recruit healthy pregnant women aged 20 to 40 in their 13th-19th week of gestation or 33rd to 39th week of gestation. Once they get in contact with the lab, an initial visit (pre-study) will take place. Here, the participants will be measured for their eligibility and taken through the consent form. They have to participate in a pre-study for each stage of pregnancy, if they wish to participate in both stages. If they meet all the criteria and agree to participate, they will return for up to two study days per stage of 8 hours each. Therefore, if they are recruited during late pregnancy they are only able to participate in two study days in total. During these study days they will be fed protein shakes containing the stable isotope, and then oxidation of this isotope will be measured to determine a breakpoint (requirement) of phenylalanine. Breath samples, urine samples, and a small blood sample will be taken during the study day.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: phenylalanine intake | Other | Dietary Supplement: Phenylalanine intakeDietary supplement: phenylalanine intake |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- over the age of twenty
- under the age of forty
- in overall good health
- pregnant with a single child
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Phenylalanine 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. | Dietary supplement | Experimental: phenylalanine intake |
Primary outcome
13C Phenylalanine Oxidation
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 14 Nov 2019.
- Derived from this study: PubMed 31758682Ennis 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.
- 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, Ph.D. 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 Phenylalanine intake in people with Pregnancy, 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 12 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 14 Nov 2019. 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?
13C Phenylalanine Oxidation (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 NCT02669381, which also lists 1 linked publication.
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 14 Nov 2019.