Determination of Protein Requirements in Pregnancy

July 13, 2017 updated by: Rajavel Elango, PhD, University of British Columbia

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

Protein is an essential part of our diet. It is used to build muscle and body tissue, send signals throughout our body and to support the immune system. Dietary protein is even more crucial during pregnancy as it is needed for healthy growth and development of the baby. There is very minimal data available on how much additional protein is required during pregnancy. Current recommendations are based on older techniques such as nitrogen balance studies of non-pregnant adults and minimally based on pregnancy specific data. There is no scientific information regarding the amount of protein needed during different stages of pregnancy.

The investigators hypothesize that the current recommendations of protein intake during pregnancy are underestimated.

The goal of this study is to measure protein requirement in healthy pregnant women (19-35y)using a more quick and modern technique called the indicator amino acid oxidation technique (IAAO).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z4H4
        • Child & Family Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:Healthy pregnant women

  • Singleton pregnancy
  • Maternal age 19-35y
  • In good health (free of chronic/acute disease,full range of physical mobility)
  • Healthy pre-pregnancy body mass index

Exclusion Criteria:Women

  • not pregnant
  • Pregnant with more than one child
  • Singleton pregnancy outside the age range of 19-35y
  • Not in good health or have a metabolic, neurological, genetic, or immune disorder, including gestational diabetes or anemia
  • smoke or consume alcohol during their pregnancy
  • classified as underweight (<18.5 kg/m2), overweight (25-30 kg/m2) or obese (>30 kg/m2)
  • allergic to eggs and egg protein
  • severe nausea/vomiting throughout their pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Protein Intake
Dietary supplement:Protein intake
Dietary supplement: Protein 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 hours (1 study day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Rajavel Elango, Ph.D, Child & Family Research Institute/University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

January 17, 2013

First Submitted That Met QC Criteria

February 1, 2013

First Posted (Estimate)

February 5, 2013

Study Record Updates

Last Update Posted (Actual)

July 18, 2017

Last Update Submitted That Met QC Criteria

July 13, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H11-00070

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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