Determination of Lysine Requirements in Pregnancy

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01776931
• Other study ID #: H11-02435
• Status: Completed
• Phase: N/A
• First received: January 17, 2013
• Last updated: July 13, 2017
• Start date: January 2012
• Est. completion date: June 2014

Study information

• Verified date: July 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

Dietary Supplement:
• Lysine 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.

Locations

Country	Name	City	State
Canada	Child & Family Research Institute	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)