NCT01776931

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 17, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 18, 2017

Status Verified

July 1, 2017

Enrollment Period

2 years

First QC Date

January 17, 2013

Last Update Submit

July 13, 2017

Conditions

Pregnancy

Keywords

Indicator Amino acid techniqueLysine requirementsPregnancyDietary protein

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

Lysine intake

EXPERIMENTAL

Dietary supplement:lysine intake

Dietary Supplement: Lysine intake

Interventions

Lysine intakeDIETARY_SUPPLEMENT

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.

Lysine intake

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child & Family Research Institute

Vancouver, British Columbia, V5Z 4H4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 29378056DERIVED

Study Officials

  • Rajavel Elango, PhD

    Child & Family Research Institute/University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 17, 2013

First Posted

January 28, 2013

Study Start

January 1, 2012

Primary Completion

January 1, 2014

Study Completion

June 1, 2014

Last Updated

July 18, 2017

Record last verified: 2017-07

Locations

CA(1)