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临床试验/NCT02669381
NCT02669381已完成不适用

Dietary Phenylalanine Requirements During Different Stages of Gestation in Healthy Pregnant Women

University of British Columbia2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
13C Phenylalanine Oxidation

研究概览

简要总结

Phenylalanine is an essential amino acid that people need to obtain in their diets. Amino acids are the building blocks for protein, which is required to form tissues in the body. It is well known that pregnant women require more protein in their diets, but the exact amount for each amino acid is undetermined. To find out how much of phenylalanine pregnant women require, the investigators plan to study pregnant women in early and late gestation with a modern minimally invasive technique.

详细描述

The investigator's purpose is to determine the phenylalanine requirements in healthy pregnant women as part of a Master's Thesis project. The determined requirements can be taken into account when giving dietary recommendations, to ensure healthy pregnancies. The hypothesis is that the current recommendations for phenylalanine intake given to pregnant women are underestimated. The investigators also hypothesize that the phenylalanine requirements at early stages of pregnancy will be lower than the requirements towards the later stages of pregnancy.

Current dietary intake recommendations for phenylalanine are based on factorial (mathematical) calculations and do not account for requirement differences between early and late pregnancy. Static recommendations throughout all stages of pregnancy are not appropriate because of the multitude of adaptations the human body goes through during gestation. Whether phenylalanine requirements differ between different stages of gestation is unknown. In addition, phenylalanine is the precursor for tyrosine, which is a conditionally indispensable amino acid. Together they are referred to as the aromatic amino acids. The DRI gives a recommendation for total aromatic amino acids (TAA, phenylalanine + tyrosine) of 36 mg/kg/d during pregnancy. Since this study is the first interested in phenylalanine requirements during pregnancy, the investigators will determine the phenylalanine requirements in the presence of excess tyrosine (61 mg/kg/d) during pregnancy, similar to earlier studies.

The investigators will recruit healthy pregnant women aged 20 to 40 in their 13th-19th week of gestation or 33rd to 39th week of gestation. Once they get in contact with the lab, an initial visit (pre-study) will take place. Here, the participants will be measured for their eligibility and taken through the consent form. They have to participate in a pre-study for each stage of pregnancy, if they wish to participate in both stages. If they meet all the criteria and agree to participate, they will return for up to two study days per stage of 8 hours each. Therefore, if they are recruited during late pregnancy they are only able to participate in two study days in total. During these study days they will be fed protein shakes containing the stable isotope, and then oxidation of this isotope will be measured to determine a breakpoint (requirement) of phenylalanine. Breath samples, urine samples, and a small blood sample will be taken during the study day.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • over the age of twenty
  • under the age of forty
  • in overall good health
  • pregnant with a single child

排除标准

  • Be under the age of twenty
  • Be over the age of forty
  • Be pregnant with more than one child
  • Have a history of cardiovascular disease, endocrine disorders, or metabolic disorders
  • Have recently lost a substantial amount of weight
  • Delivered a baby in the last 18 months
  • Be substance dependent
  • Be allergic to eggs
  • Have severe nausea through the pregnancy
  • Have gestational diabetes
  • Have a history of spontaneous abortions
  • Have had an unhealthy pre-pregnancy body mass index

结局指标

主要结局

13C Phenylalanine Oxidation

时间窗: 8 hours

Urine, breath and a single blood sample will be collected during the study to measure the rate of oxidation of 13C phenylalanine.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rajavel Elango, PhD

Principle Investigator

University of British Columbia

研究点 (2)

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