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Determination of Glycine Requirement in Pregnancy

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ClinicalTrials.gov Identifier: NCT02149953
Recruitment Status : Recruiting
First Posted : May 29, 2014
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
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
Estimated Primary Completion Date : December 30, 2017
Estimated Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine

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
Criteria

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


Contacts
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Contact: Rajavel Elango, PhD 604 875 2000 ext 4911 relango@bcchr.ubc.ca
Contact: Betina Rasmussen, MSc 604 875 ext 4607 brasmussen@bcchr.ca

Locations
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Canada, British Columbia
BC Children's Hospital Research Institute Recruiting
Vancouver, British Columbia, Canada, V5Z4H4
Contact: Rajavel Elango, Ph.D    604 875 2000 ext 4911    relango@bcchr.ubc.ca   
Principal Investigator: Rajavel Elango, Ph.D         
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Rajavel Elango, Ph.D University of British Columbia

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Responsible Party: Rajavel Elango, PhD, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02149953     History of Changes
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: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rajavel Elango, PhD, University of British Columbia:
Pregnancy
Glycine requirements
Indicator Amino Acid Oxidation (IAAO) method
Stable isotopes
Additional relevant MeSH terms:
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Glycine
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs