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Determination of Lysine Requirements in Pregnancy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01776931
First Posted: January 28, 2013
Last Update Posted: July 18, 2017
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.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Rajavel Elango, PhD, University of British Columbia
  Purpose

Amino acids are building blocks of protein in our body. It is important that pregnant women eat adequate amount of protein/amino acids to ensure healthy growth and development of the fetus.Lysine is an amino acid that is present in high amounts only in animal foods (meat) and not much in plant foods such as wheat. Currently , it is not known how much lysine is needed to eat during pregnancy.

Current Dietary Reference Intake recommendations for amino acid requirements are based on non-pregnant adults, and minimally based on pregnancy-specific data.To the investigators knowledge, there is no scientific information regarding the amount of lysine needed at different stages of pregnancy.

The investigators hypothesize that current recommendations for lysine intake in pregnant women are underestimated. The investigators also hypothesize that the lysine requirements will be greater during the later stages of pregnancy, compared to early stages.

The purpose of this study is to determine lysine requirements in healthy pregnant women 19-40y,(1st and 3rd trimester) using a modern, safe and quick technique called the indicator amino acid oxidation technique and to compare lysine requirements during early (15-18 weeks last menstrual period) late (33-36 weeks last menstrual period) stages of pregnancy.


Condition Intervention
Pregnancy Dietary Supplement: Lysine intake

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Determination of Lysine Requirements in Healthy Pregnant Women Using the Indicator Amino Acid Oxidation Technique

Resource links provided by NLM:


Further study details as provided by Rajavel Elango, PhD, University of British Columbia:

Primary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: January 2012
Study Completion Date: June 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lysine intake
Dietary supplement:lysine intake
Dietary Supplement: Lysine 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Singleton pregnancy
  • Maternal age 19-40y
  • Early stage of pregnancy(15-18 weeks) and late stage of pregnancy(33-36 weeks)
  • In good health (free of chronic/acute illness, full range of physical mobility)
  • Healthy pre-pregnancy body mass index

Exclusion Criteria:

  • Subjects outside the age range of 19-40y
  • Women pregnant with more than one child
  • Body mass Index less than 18.5kg/m2 or greater than 25 kg/m2
  • less than 18 months between current pregnancy and last pregnancy
  • History of spontaneous abortion,pre-term birth, preeclampsia/eclampsia, gestational diabetes, pregnancy-related anemia, pregnancy related jaundice
  • Existing metabolic disease
  • Substance dependance (i.e. alcohol, cigarette, illicit drugs)
  • Allergic to eggs and egg protein
  • Severe nausea and vomiting during pregnancy
  Contacts and Locations
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): NCT01776931


Locations
Canada, British Columbia
Child & Family Research Institute
Vancouver, British Columbia, Canada, V5Z 4H4
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Rajavel Elango, PhD Child & Family Research Institute/University of British Columbia
  More Information

Responsible Party: Rajavel Elango, PhD, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT01776931     History of Changes
Other Study ID Numbers: H11-02435
First Submitted: January 17, 2013
First Posted: January 28, 2013
Last Update Posted: July 18, 2017
Last Verified: July 2017

Keywords provided by Rajavel Elango, PhD, University of British Columbia:
Indicator Amino acid technique
Lysine requirements
Pregnancy
Dietary protein