Clinical trial NCT01776931: Determination of Lysine Requirements in Pregnancy
Official title: Determination of Lysine Requirements in Healthy Pregnant Women Using the Indicator Amino Acid Oxidation Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Indicator Amino acid technique
Lysine requirements
Pregnancy
Dietary protein
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2013-01-28
Enrollment: 20
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: 13 carbon dioxide production
timeFrame: 8 hours (1 study day)
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Child & Family Research Institute
state: British Columbia
Study officials:
affiliation: Child & Family Research Institute/University of British Columbia
name: Rajavel Elango, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.