Determination of Lysine Requirements in Pregnancy

Determination of Lysine Requirements in Healthy Pregnant Women Using the Indicator Amino Acid Oxidation Technique

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Dietary supplement: Lysine intake

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4H4
      • Child & Family Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
13 carbon dioxide production	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.	8 hours (1 study day)

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Rajavel Elango, PhD, Child & Family Research Institute/University of British Columbia

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: January 17, 2013
• First Submitted That Met QC Criteria: January 23, 2013
• First Posted (Estimate): January 28, 2013

Study Record Updates

• Last Update Posted (Actual): July 18, 2017
• Last Update Submitted That Met QC Criteria: July 13, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Pregnancy; Indicator Amino acid technique; Lysine requirements; Dietary protein
• Other Study ID Numbers: H11-02435

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No