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Determination of Glycine Requirement in Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02149953
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : September 23, 2020
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Rajavel Elango, PhD, University of British Columbia

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Pregnancy Dietary Supplement: Glycine Intake Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Determination Glycine Requirements During Healthy Pregnancy Using the Indicator Amino Acid Oxidation (IAAO) Technique
Actual Study Start Date : September 19, 2014
Actual Primary Completion Date : September 26, 2016
Actual Study Completion Date : September 26, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy
Drug Information available for: Glycine

Arm Intervention/treatment
Experimental: Glycine intake
Dietary supplement: Glycine intake
Dietary Supplement: Glycine Intake
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.

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02149953

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Canada, British Columbia
BC Children's Hospital Research Institute
Vancouver, British Columbia, Canada, V5Z4H4
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
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Principal Investigator: Rajavel Elango, Ph.D University of British Columbia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rajavel Elango, PhD, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02149953    
Other Study ID Numbers: H14-00495
F13-04173 ( Other Grant/Funding Number: Canadian Institute of Health Research )
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rajavel Elango, PhD, University of British Columbia:
Glycine requirements
Indicator Amino Acid Oxidation (IAAO) method
Stable isotopes
Additional relevant MeSH terms:
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Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs