Determination of Lysine Requirements in Pregnancy

Study Overview
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Brief Summary
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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.

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

Conditions
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Pregnancy

Intervention / Treatment
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* Dietary Supplement: Lysine intake


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lysine intake<br>Dietary supplement:lysine intake | Dietary Supplement: Lysine intake<br>* 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.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indicator Amino acid technique, Lysine requirements, Pregnancy, Dietary protein