Determination of Lysine Requirements in Pregnancy

NCT ID: NCT01776931

Last Updated: 2017-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-06-30

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.

Conditions

Pregnancy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Lysine intake

Dietary supplement:lysine intake

Group Type: EXPERIMENTAL

Lysine intake

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Rajavel Elango, PhD

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rajavel Elango, PhD

Role: PRINCIPAL_INVESTIGATOR

Child & Family Research Institute/University of British Columbia

Locations

Child & Family Research Institute

Vancouver, British Columbia, Canada

Countries

Canada

References

Payne M, Stephens T, Lim K, Ball RO, Pencharz PB, Elango R. Lysine Requirements of Healthy Pregnant Women are Higher During Late Stages of Gestation Compared to Early Gestation. J Nutr. 2018 Jan 1;148(1):94-99. doi: 10.1093/jn/nxx034.

Reference Type: DERIVED

PMID: 29378056 (View on PubMed)

Other Identifiers

H11-02435

Identifier Type: -

Identifier Source: org_study_id