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Determination of Protein Requirements in Pregnancy

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ClinicalTrials.gov Identifier: NCT01784198
Recruitment Status : Completed
First Posted : February 5, 2013
Last Update Posted : July 18, 2017
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Rajavel Elango, PhD, University of British Columbia

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Pregnancy Dietary Supplement: Protein Intake Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Determination of Protein Requirements in Healthy Pregnant Women Using Indicator Amino Acid Oxidation Technique
Study Start Date : April 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : March 2014

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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   19 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT01784198


Locations
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Canada, British Columbia
Child & Family Research Institute
Vancouver, British Columbia, Canada, V5Z4H4
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Rajavel Elango, Ph.D Child & Family Research Institute/University of British Columbia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rajavel Elango, PhD, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT01784198     History of Changes
Other Study ID Numbers: H11-00070
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017
Keywords provided by Rajavel Elango, PhD, University of British Columbia:
pregnancy
protein requirements
Indicator Amino acid oxidation
Stable isotopes