PregnancyNCT01784198
Determination of Protein Requirements in Pregnancy
A study testing Protein Intake in people with Pregnancy, run by University of British Columbia at 1 site in Canada.
Trial summary
Protein is an essential part of our diet. It is used to build muscle and body tissue, send signals throughout our body and to support the immune system. Dietary protein is even more crucial during pregnancy as it is needed for healthy growth and development of the baby. Read more about this study
- Who is it for?
- Ages 19 to 35 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Protein Intake
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2011to Mar 2014
- 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 19 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnancy
- Maternal age 19-35y
- In good health (free of chronic/acute disease,full range of physical mobility)
- Healthy pre-pregnancy body mass index
Who cannot join
- not pregnant
- Pregnant with more than one child
- Singleton pregnancy outside the age range of 19-35y
- Not in good health or have a metabolic, neurological, genetic, or immune disorder, including gestational diabetes or anemia
- smoke or consume alcohol during their pregnancy
- classified as underweight (<18.5 kg/m2), overweight (25-30 kg/m2) or obese (>30 kg/m2)
- allergic to eggs and egg protein
- severe nausea/vomiting throughout their pregnancy
Trial locations and contacts
1 site in 1 country.
Canada1 site
Child & Family Research Institute
Vancouver, British Columbia, V5Z4H4
About this study
Official title: Determination of Protein Requirements in Healthy Pregnant Women Using Indicator Amino Acid Oxidation Technique
Protein is an essential part of our diet. It is used to build muscle and body tissue, send signals throughout our body and to support the immune system. Dietary protein is even more crucial during pregnancy as it is needed for healthy growth and development of the baby. There is very minimal data available on how much additional protein is required during pregnancy. Current recommendations are based on older techniques such as nitrogen balance studies of non-pregnant adults and minimally based on pregnancy specific data. There is no scientific information regarding the amount of protein needed during different stages of pregnancy.
The investigators hypothesize that the current recommendations of protein intake during pregnancy are underestimated.
The goal of this study is to measure protein requirement in healthy pregnant women (19-35y)using a more quick and modern technique called the indicator amino acid oxidation technique (IAAO).
- Conditions
- Pregnancy
- Being tested
- Protein Intake
- Keywords
- pregnancy, protein requirements, Indicator Amino acid oxidation, Stable isotopes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein 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 |
|---|---|---|
| Protein Intake | Experimental | Dietary supplement:Protein intake Receives: Dietary Supplement: Protein Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
13 Carbon dioxide production
Urine and breath samples will be collected during the study to measure the rate of oxidation of tracer in expired breath and flux by enrichment in urine.
Measured: 8 hours (1 study day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startApr 2011
- Primary completionDec 2013
- Study completionMar 2014
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 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, Child & Family Research Institute/University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784198
- Sponsor's protocol ID
- H11-00070
- Status last verified
- Jul 2017
- First submitted
- 17 Jan 2013
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stephens TV, Payne M, Ball RO, Pencharz PB, Elango R. Protein requirements of healthy pregnant women during early and late gestation are higher than current recommendations. J Nutr. 2015 Jan;145(1):73-8. doi: 10.3945/jn.114.198622. Epub 2014 Sep 24.
PubMed 25527661
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Protein Requirements in Healthy Pregnant Women Using Indicator Amino Acid Oxidation Technique
- ClinicalTrials.gov ID
- NCT01784198
- Acronym / sponsor ID
- H11-00070
- Conditions
- Pregnancy
- Keywords
- pregnancy, protein requirements, Indicator Amino acid oxidation, Stable isotopes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Apr 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 5 Feb 2013 (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.
Protein is an essential part of our diet. It is used to build muscle and body tissue, send signals throughout our body and to support the immune system. Dietary protein is even more crucial during pregnancy as it is needed for healthy growth and development of the baby. There is very minimal data available on how much additional protein is required during pregnancy. Current recommendations are based on older techniques such as nitrogen balance studies of non-pregnant adults and minimally based on pregnancy specific data. There is no scientific information regarding the amount of protein needed during different stages of pregnancy.
The investigators hypothesize that the current recommendations of protein intake during pregnancy are underestimated.
The goal of this study is to measure protein requirement in healthy pregnant women (19-35y)using a more quick and modern technique called the indicator amino acid oxidation technique (IAAO).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Protein Intake | Experimental | Dietary Supplement: Protein IntakeDietary supplement:Protein intake |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Singleton pregnancy
- Maternal age 19-35y
- In good health (free of chronic/acute disease,full range of physical mobility)
- Healthy pre-pregnancy body mass index
Key exclusion criteria (8 listed)
- not pregnant
- Pregnant with more than one child
- Singleton pregnancy outside the age range of 19-35y
- Not in good health or have a metabolic, neurological, genetic, or immune disorder, including gestational diabetes or anemia
- smoke or consume alcohol during their pregnancy
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 |
|---|---|---|
| Protein 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 | Protein Intake |
Primary outcome
13 Carbon dioxide production
Time frame: 8 hours (1 study day)
Urine and breath samples will be collected during the study to measure the rate of oxidation of tracer in expired breath and flux by enrichment in urine.
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 18 Jul 2017.
- Derived from this study: PubMed 25527661Stephens TV, Payne M, Ball RO, Pencharz PB, Elango R. Protein requirements of healthy pregnant women during early and late gestation are higher than current recommendations. J Nutr. 2015 Jan;145(1):73-8. doi: 10.3945/jn.114.198622. Epub 2014 Sep 24.
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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
Child & Family Research Institute/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 Protein 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 8 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 18 Jul 2017. 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?
13 Carbon dioxide production (time frame: 8 hours (1 study day)). 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 NCT01784198, 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 18 Jul 2017.