Determination of Lysine Requirements in Pregnancy
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|ClinicalTrials.gov Identifier: NCT01776931|
Recruitment Status : Completed
First Posted : January 28, 2013
Last Update Posted : July 18, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy||Dietary Supplement: Lysine intake||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Determination of Lysine Requirements in Healthy Pregnant Women Using the Indicator Amino Acid Oxidation Technique|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||June 2014|
Experimental: Lysine intake
Dietary supplement:lysine intake
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01776931
|Canada, British Columbia|
|Child & Family Research Institute|
|Vancouver, British Columbia, Canada, V5Z 4H4|
|Principal Investigator:||Rajavel Elango, PhD||Child & Family Research Institute/University of British Columbia|