Determination of Protein Requirements in Pregnancy

NCT01784198 | Completed DMC

• 1 other identifier: H11-00070
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Pregnancy

Keywords

pregnancy; protein requirements; Indicator Amino acid oxidation; Stable isotopes

Outcome Measures

Primary Outcomes (1)

• 13 Carbon dioxide production

  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)

Study Arms (1)

Protein Intake

EXPERIMENTAL

Dietary supplement:Protein intake

Dietary Supplement: Protein Intake

Interventions

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.

Protein Intake

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Child & Family Research Institute

Vancouver, British Columbia, V5Z4H4, Canada

Location

Related Publications (1)

• Stephens TV, Payne M, Ball RO, Pencharz PB, Elango R. Protein requirements of healthy pregnant women during early and late gestation are higher than current recommendations. J Nutr. 2015 Jan;145(1):73-8. doi: 10.3945/jn.114.198622. Epub 2014 Sep 24.

  PMID: 25527661 DERIVED

Study Officials

• Rajavel Elango, Ph.D

  Child & Family Research Institute/University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 17, 2013
• First Posted: February 5, 2013
• Study Start: April 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: July 18, 2017

Record last verified: 2017-07

Locations

CA (1)