PregnancyNCT02149953
Determination of Glycine Requirement in Pregnancy
A study testing Glycine Intake in people with Pregnancy, run by University of British Columbia at 1 site in Canada.
Trial summary
It is important that pregnant women eat an adequate amount of protein to ensure healthy growth and development of the fetus. Amino acids are the building blocks of the body's protein. Glycine is an amino acid that can be made in the body, but under certain metabolic circumstances (e.g. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Glycine Intake
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- 19 Sep 2014to 26 Sep 2016
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Healthy pregnant women aged 20 - 40 yrs
- Singleton pregnancy
- Mid (20 - 30 weeks of gestation) or late stages of pregnancy (31 - 40 weeks of gestation).
- In good health (Free of chronic diseases/acute diseases, full range of physical mobility)
Who cannot join
- Women who are not pregnant
- Women who are pregnant with more than one child
- Women with history of spontaneous abortion, pre-term birth
- Women who are not in good health or have metabolic, neurologic or immune disorders including; preeclampsia/eclampsia, gestational diabetes, pregnancy-related anemia, pregnancy- related jaundice.
- Women who are substance dependent (i.e. alcohol, cigarette, illicit drugs)
- Women allergic to egg/ egg protein
- Women who have experienced severe nausea and vomiting throughout pregnancy
- Women who are claustrophobic
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Children's Hospital Research Institute
Vancouver, British Columbia, V5Z4H4
About this study
Official title: Determination Glycine Requirements During Healthy Pregnancy Using the Indicator Amino Acid Oxidation (IAAO) Technique
It is important that pregnant women eat an adequate amount of protein to ensure healthy growth and development of the fetus. Amino acids are the building blocks of the body's protein. Glycine is an amino acid that can be made in the body, but under certain metabolic circumstances (e.g. pregnancy) the body's needs may be higher and thus glycine must be obtained from the diet. Currently, it is not known how much glycine may be needed from the diet during pregnancy. We plan to study dietary glycine requirements in healthy pregnant women, during early and late gestation. We will do this using a modern, safe and quick method.
Read the detailed description
Purpose:
To determine the dietary glycine requirement in healthy pregnant women during mid (20 - 30 weeks) and late (31 - 40 weeks) gestation.
Hypothesis:
We hypothesize that there is a dietary requirement for glycine during pregnancy due to an increased metabolic demand. With increased glycine intake we hypothesize to observe an increase in protein synthesis, as measured by the indicator amino acid oxidation (IAAO) method.
Justification:
Inadequate protein intake during pregnancy may cause intrauterine growth restriction, which is associated with increased risk of chronic diseases later in life. Currently, the dietary intake recommendations for amino acids are greatly based on nitrogen balance studies of non-pregnant adults. There is little scientific information regarding dietary glycine needs during different stages of pregnancy, despite empirical evidence indicating gestational differences in protein metabolism.
Objectives:
The main objective of the current study is to determine the glycine requirement using the minimally invasive indicator amino acid oxidation (IAAO) method in healthy pregnant women. Our second objective is to compare the glycine requirement during mid (20-30 weeks gestation) and late (31 - 40 weeks gestation) stages of pregnancy.
Research methods:
We will recruit a minimum of 18 pregnant women who may take part in 2 study days in both gestational stages, for a total of 72 study days. Potential participants will meet us for a preliminary assessment where we will evaluate their eligibility to participate in the study. The preliminary study will take approximately 1 hr during which we will examine body composition (bioelectrical impedance, skin-fold measurements, height and weight), resting energy expenditure (indirect calorimetry), blood glucose (glucometer), and medical history (questionnaire). Fasted blood glucose above 6.7 mmol/L is indicative of gestational diabetes. Participants with fasted blood glucose concentrations above 6.7 mmol/L will be referred to follow-up with their primary health care provider (see letter to physician).
We will test the participants urine using a dipstick, to assess whether proteinurea is present. If there is an indication of proteinurea we will refer the participant to their primary physician (See letter to physician - Urine results).
We will collect a 3 day diet record to determine usual food intake and food preferences. Based on the 3 day food record we will prescribe a standardized diet two days prior to the study day to ensure protein intake of 1.5 g/kg/d and energy intake of 1.7 x resting energy.
During each study day, eligible participants will randomly receive 1 of 36 test glycine intakes during both mid and late pregnancy, ranging from 10 to 100 mg/kg/d. Each subject may participate in 2 study days between 20-30 weeks gestation and 2 study days between 31 - 40 weeks gestation, for a total of 4 study days. The test glycine intakes will contain a crystalline L-amino acid mixture based on the composition of egg protein, except for glycine. The test glycine intake will be administered in an experimental diet, along with enough non-protein energy to meet 1.7 x resting energy expenditure of each participant. The diet will be provided as 8 meals, each representing 1/12th of the participant's daily intake requirement. These meals will be provided over the course of an 8 hour study day. A stable isotope tracer will be added to the 5th - 8th meal. We will measure the rate of oxidation of this tracer in expired breath (F13CO2), and flux of this tracer by its enrichment in urine.
- Conditions
- Pregnancy
- Being tested
- Glycine Intake
- Keywords
- Pregnancy, Glycine requirements, Indicator Amino Acid Oxidation (IAAO) method, Stable isotopes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycine 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 |
|---|---|---|
| Glycine intake | Experimental | Dietary supplement: Glycine intake Receives: Dietary Supplement: Glycine Intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
13 Carbon dioxide production
Urine, breath and a single blood sample 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study start19 Sep 2014
- Primary completion26 Sep 2016
- Study completion26 Sep 2016
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
- 13 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
- NCT02149953
- Sponsor's protocol ID
- H14-00495
- Other IDs
- F13-04173
- Status last verified
- Sep 2020
- First submitted
- 26 May 2014
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Rasmussen BF, Ennis MA, Dyer RA, Lim K, Elango R. Glycine, a Dispensable Amino Acid, Is Conditionally Indispensable in Late Stages of Human Pregnancy. J Nutr. 2021 Feb 1;151(2):361-369. doi: 10.1093/jn/nxaa263.
PubMed 32939556
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
- Determination Glycine Requirements During Healthy Pregnancy Using the Indicator Amino Acid Oxidation (IAAO) Technique
- ClinicalTrials.gov ID
- NCT02149953
- Acronym / sponsor ID
- H14-00495
- Conditions
- Pregnancy
- Keywords
- Pregnancy, Glycine requirements, Indicator Amino Acid Oxidation (IAAO) method, Stable isotopes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 19 Sep 2014 (actual)
- Primary completion
- 26 Sep 2016 (actual)
- Study completion
- 26 Sep 2016 (actual)
- First posted
- 29 May 2014 (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.
It is important that pregnant women eat an adequate amount of protein to ensure healthy growth and development of the fetus. Amino acids are the building blocks of the body's protein. Glycine is an amino acid that can be made in the body, but under certain metabolic circumstances (e.g. pregnancy) the body's needs may be higher and thus glycine must be obtained from the diet. Currently, it is not known how much glycine may be needed from the diet during pregnancy. We plan to study dietary glycine requirements in healthy pregnant women, during early and late gestation. We will do this using a modern, safe and quick method.
Detailed description
Purpose:
To determine the dietary glycine requirement in healthy pregnant women during mid (20 - 30 weeks) and late (31 - 40 weeks) gestation.
Hypothesis:
We hypothesize that there is a dietary requirement for glycine during pregnancy due to an increased metabolic demand. With increased glycine intake we hypothesize to observe an increase in protein synthesis, as measured by the indicator amino acid oxidation (IAAO) method.
Justification:
Inadequate protein intake during pregnancy may cause intrauterine growth restriction, which is associated with increased risk of chronic diseases later in life. Currently, the dietary intake recommendations for amino acids are greatly based on nitrogen balance studies of non-pregnant adults. There is little scientific information regarding dietary glycine needs during different stages of pregnancy, despite empirical evidence indicating gestational differences in protein metabolism.
Objectives:
The main objective of the current study is to determine the glycine requirement using the minimally invasive indicator amino acid oxidation (IAAO) method in healthy pregnant women. Our second objective is to compare the glycine requirement during mid (20-30 weeks gestation) and late (31 - 40 weeks gestation) stages of pregnancy.
Research methods:
We will recruit a minimum of 18 pregnant women who may take part in 2 study days in both gestational stages, for a total of 72 study days. Potential participants will meet us for a preliminary assessment where we will evaluate their eligibility to participate in the study. The preliminary study will take approximately 1 hr during which we will examine body composition (bioelectrical impedance, skin-fold measurements, height and weight), resting energy expenditure (indirect calorimetry), blood glucose (glucometer), and medical history (questionnaire). Fasted blood glucose above 6.7 mmol/L is indicative of gestational diabetes. Participants with fasted blood glucose concentrations above 6.7 mmol/L will be referred to follow-up with their primary health care provider (see letter to physician).
We will test the participants urine using a dipstick, to assess whether proteinurea is present. If there is an indication of proteinurea we will refer the participant to their primary physician (See letter to physician - Urine results).
We will collect a 3 day diet record to determine usual food intake and food preferences. Based on the 3 day food record we will prescribe a standardized diet two days prior to the study day to ensure protein intake of 1.5 g/kg/d and energy intake of 1.7 x resting energy.
During each study day, eligible participants will randomly receive 1 of 36 test glycine intakes during both mid and late pregnancy, ranging from 10 to 100 mg/kg/d. Each subject may participate in 2 study days between 20-30 weeks gestation and 2 study days between 31 - 40 weeks gestation, for a total of 4 study days. The test glycine intakes will contain a crystalline L-amino acid mixture based on the composition of egg protein, except for glycine. The test glycine intake will be administered in an experimental diet, along with enough non-protein energy to meet 1.7 x resting energy expenditure of each participant. The diet will be provided as 8 meals, each representing 1/12th of the participant's daily intake requirement. These meals will be provided over the course of an 8 hour study day. A stable isotope tracer will be added to the 5th - 8th meal. We will measure the rate of oxidation of this tracer in expired breath (F13CO2), and flux of this tracer by its enrichment in urine.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glycine intake | Experimental | Dietary Supplement: Glycine IntakeDietary supplement: Glycine intake |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy pregnant women aged 20 - 40 yrs
- Singleton pregnancy
- Mid (20 - 30 weeks of gestation) or late stages of pregnancy (31 - 40 weeks of gestation).
- In good health (Free of chronic diseases/acute diseases, full range of physical mobility)
Key exclusion criteria (8 listed)
- Women who are not pregnant
- Women who are pregnant with more than one child
- Women with history of spontaneous abortion, pre-term birth
- Women who are not in good health or have metabolic, neurologic or immune disorders including; preeclampsia/eclampsia, gestational diabetes, pregnancy-related anemia, pregnancy- related jaundice.
- Women who are substance dependent (i.e. alcohol, cigarette, illicit drugs)
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 |
|---|---|---|
| Glycine 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 | Glycine intake |
Primary outcome
13 Carbon dioxide production
Time frame: 8 hours
Urine, breath and a single blood sample 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 23 Sep 2020.
- Derived from this study: PubMed 32939556Rasmussen BF, Ennis MA, Dyer RA, Lim K, Elango R. Glycine, a Dispensable Amino Acid, Is Conditionally Indispensable in Late Stages of Human Pregnancy. J Nutr. 2021 Feb 1;151(2):361-369. doi: 10.1093/jn/nxaa263.
- 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 Glycine 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 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?
13 Carbon dioxide production (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 NCT02149953, 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 23 Sep 2020.