Pregnancy RelatedNCT03409939
Determining Total Aromatic Amino Acid Requirements in Pregnant Women
A study testing Aromatic Amino Acid Intake in people with Pregnancy Related, run by University of British Columbia at 1 site in Canada.
Trial 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. 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?
- Aromatic Amino Acid Intake
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2018to 17 Jan 2020
- 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
- Have been pregnant with another child 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
Clinical Research and Evaluation Unit
Vancouver, British Columbia, V6H3N1
About this study
Official title: Determining Dietary Total Aromatic Amino Acid (Phenylalanine and Tyrosine) Requirements During Different Stages of Gestation in Healthy Pregnant Women
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.
Read the detailed description
Following a study to determine phenylalanine requirements in pregnant women, the investigator's purpose for this study is to determine the phenylalanine and tyrosine requirements (also know as the total aromatic amino acid requirement) in healthy pregnant women as part of a Doctoral 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 and tyrosine intake given to pregnant women are underestimated. The investigators also hypothesize that the phenylalanine and tyrosine requirements at early stages of pregnancy will be lower than the requirements towards the later stages of pregnancy.
Current dietary intake recommendations for the aromatic amino acids 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 and tyrosine requirements differ between different stages of gestation is unknown. The DRI gives a recommendation for total aromatic amino acids of 36 mg/kg/d during pregnancy. The results from this study would allow for a more accurate recommendations in future DRIs.
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 four study days per stage of 8 hours each. Therefore, if they are recruited during late pregnancy they are only able to participate in four 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 Related
- Being tested
- Aromatic Amino Acid Intake
- Keywords
- nutrition, phenylalanine, tyrosine, stable isotope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Aromatic Amino Acid 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 posted24 Jan 2018
- Study start1 Feb 2018
- Primary completion17 Jan 2020
- Study completion17 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 19 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, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409939
- Sponsor's protocol ID
- H17-02924
- Status last verified
- Sep 2020
- First submitted
- 18 Jan 2018
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Dietary Total Aromatic Amino Acid (Phenylalanine and Tyrosine) Requirements During Different Stages of Gestation in Healthy Pregnant Women
- ClinicalTrials.gov ID
- NCT03409939
- Acronym / sponsor ID
- H17-02924
- Conditions
- Pregnancy Related
- Keywords
- nutrition, phenylalanine, tyrosine, stable isotope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 24 Jan 2018 (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.
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.
Detailed description
Following a study to determine phenylalanine requirements in pregnant women, the investigator's purpose for this study is to determine the phenylalanine and tyrosine requirements (also know as the total aromatic amino acid requirement) in healthy pregnant women as part of a Doctoral 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 and tyrosine intake given to pregnant women are underestimated. The investigators also hypothesize that the phenylalanine and tyrosine requirements at early stages of pregnancy will be lower than the requirements towards the later stages of pregnancy.
Current dietary intake recommendations for the aromatic amino acids 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 and tyrosine requirements differ between different stages of gestation is unknown. The DRI gives a recommendation for total aromatic amino acids of 36 mg/kg/d during pregnancy. The results from this study would allow for a more accurate recommendations in future DRIs.
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 four study days per stage of 8 hours each. Therefore, if they are recruited during late pregnancy they are only able to participate in four 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 |
|---|---|---|
| Aromatic Amino Acid Intake | Experimental | Dietary Supplement: Aromatic Amino Acid 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)
- 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 |
|---|---|---|
| Aromatic Amino Acid IntakeIntakes will be randomly chosen from a list of 8 doses of aromatic amino acids. Each intake will will be repeated approximately 4 times. | Dietary supplement | Aromatic Amino Acid 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 23 Sep 2020.
- 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 Aromatic Amino Acid 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 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 23 Sep 2020. 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?
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 23 Sep 2020.