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OpenTrials
Completed

NCT Number: NCT01784198

Determination of Protein Requirements in Pregnancy

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).

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Key information

Conditions

Age range

19 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Child & Family Research Institute

Vancouver, British Columbia, V5Z4H4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

protein 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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Feb 5, 2013
Registry last updated
Jul 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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