Text Size

Determination of Lysine Requirements in Pregnancy

This study is currently recruiting participants.
Verified February 2013 by University of British Columbia
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01776931
First received: January 17, 2013
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  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: Single Blind (Subject)
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:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 13 carbon dioxide production [ Time Frame: 8 hours (1 study day) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (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

Ages Eligible for Study:   19 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776931

Locations
Canada, British Columbia
Child & Family Research Institute Recruiting
Vancouver, British Columbia, Canada, V5Z 4H4
Contact: Rajavel Elango, PhD         relango@cfri.ubc.ca    
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

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01776931     History of Changes
Other Study ID Numbers: H11-02435
Study First Received: January 17, 2013
Last Updated: February 4, 2013
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on May 23, 2013