Determination of Lysine Requirements in Pregnancy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy

Age range

19 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Child & Family Research Institute

Vancouver, British Columbia, V5Z 4H4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lysine intake

Dietary 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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Jan 28, 2013
Registry last updated: Jul 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed