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Determination of Lysine Requirements in Pregnancy

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

Tracking Information
First Submitted Date  ICMJE January 17, 2013
First Posted Date  ICMJE January 28, 2013
Last Update Posted Date July 18, 2017
Study Start Date  ICMJE January 2012
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01776931 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Determination of Lysine Requirements in Pregnancy
Official Title  ICMJE Determination of Lysine Requirements in Healthy Pregnant Women Using the Indicator Amino Acid Oxidation Technique
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Pregnancy
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Lysine intake
Dietary supplement:lysine intake
Intervention: Dietary Supplement: Lysine intake
Publications * Payne M, Stephens T, Lim K, Ball RO, Pencharz PB, Elango R. Lysine Requirements of Healthy Pregnant Women are Higher During Late Stages of Gestation Compared to Early Gestation. J Nutr. 2018 Jan 1;148(1):94-99. doi: 10.1093/jn/nxx034.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2013)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01776931
Other Study ID Numbers  ICMJE H11-02435
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rajavel Elango, PhD, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Rajavel Elango, PhD Child & Family Research Institute/University of British Columbia
PRS Account University of British Columbia
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP