Determination of Protein Requirements in Pregnancy

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01784198
• Other study ID #: H11-00070
• Status: Completed
• Phase: N/A
• First received: January 17, 2013
• Last updated: July 13, 2017
• Start date: April 2011
• Est. completion date: March 2014

Study information

• Verified date: July 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
Canada	Child & Family Research Institute	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)