Determination of Glycine Requirement in Pregnancy

NCT02149953 | Completed DMC

• 2 other identifiers: H14-00495F13-04173
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

It is important that pregnant women eat an adequate amount of protein to ensure healthy growth and development of the fetus. Amino acids are the building blocks of the body's protein. Glycine is an amino acid that can be made in the body, but under certain metabolic circumstances (e.g. pregnancy) the body's needs may be higher and thus glycine must be obtained from the diet. Currently, it is not known how much glycine may be needed from the diet during pregnancy. We plan to study dietary glycine requirements in healthy pregnant women, during early and late gestation. We will do this using a modern, safe and quick method.

Conditions

Pregnancy

Keywords

Pregnancy; Glycine requirements; Indicator Amino Acid Oxidation (IAAO) method; Stable isotopes

Outcome Measures

Primary Outcomes (1)

• 13 Carbon dioxide production

  Urine, breath and a single blood sample 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

Study Arms (1)

Glycine intake

EXPERIMENTAL

Dietary supplement: Glycine intake

Dietary Supplement: Glycine Intake

Interventions

Glycine Intake 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.

Glycine intake

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy pregnant women aged 20 - 40 yrs
• Singleton pregnancy
• Mid (20 - 30 weeks of gestation) or late stages of pregnancy (31 - 40 weeks of gestation).
• In good health (Free of chronic diseases/acute diseases, full range of physical mobility)

You may not qualify if:

• Women who are not pregnant
• Women who are pregnant with more than one child
• Women with history of spontaneous abortion, pre-term birth
• Women who are not in good health or have metabolic, neurologic or immune disorders including; preeclampsia/eclampsia, gestational diabetes, pregnancy-related anemia, pregnancy- related jaundice.
• Women who are substance dependent (i.e. alcohol, cigarette, illicit drugs)
• Women allergic to egg/ egg protein
• Women who have experienced severe nausea and vomiting throughout pregnancy
• Women who are claustrophobic

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

BC Children's Hospital Research Institute

Vancouver, British Columbia, V5Z4H4, Canada

Location

Related Publications (1)

• Rasmussen BF, Ennis MA, Dyer RA, Lim K, Elango R. Glycine, a Dispensable Amino Acid, Is Conditionally Indispensable in Late Stages of Human Pregnancy. J Nutr. 2021 Feb 1;151(2):361-369. doi: 10.1093/jn/nxaa263.

  PMID: 32939556 DERIVED

Study Officials

• Rajavel Elango, Ph.D

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 26, 2014
• First Posted: May 29, 2014
• Study Start: September 19, 2014
• Primary Completion: September 26, 2016
• Study Completion: September 26, 2016
• Last Updated: September 23, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)