Determination of Protein Requirements in Pregnancy

NCT ID: NCT01784198

Last Updated: 2017-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2014-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Protein Intake

Dietary supplement:Protein intake

Group Type: EXPERIMENTAL

Protein Intake

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Rajavel Elango, PhD

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rajavel Elango, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Child & Family Research Institute/University of British Columbia

Locations

Child & Family Research Institute

Vancouver, British Columbia, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 25527661 (View on PubMed)

Other Identifiers

H11-00070

Identifier Type: -

Identifier Source: org_study_id