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Determination of Lysine Requirements in Pregnancy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01776931
Enrollment
20
Registered
2013-01-28
Start date
2012-01-31
Completion date
2014-06-30
Last updated
2017-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Indicator Amino acid technique, Lysine requirements, Pregnancy, Dietary protein

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.

Interventions

DIETARY_SUPPLEMENTLysine 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.

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
University of British Columbia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
13 carbon dioxide production8 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026