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临床试验/NCT03218956
NCT03218956已完成不适用

Determination of Dietary Protein Requirements in Healthy Women During Stages of Lactation

University of British Columbia2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2017年9月30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
13
试验地点
2
主要终点
13C Phenylalanine Oxidation

研究概览

简要总结

It is well established that a breast-feeding women need more protein in their diet compared to non-lactating women, but how much additional protein is needed remains unclear. There is reason to believe that the current Dietary Reference Intake (DRI) recommendations for breast-feeding women are too low. To gain better understanding, we plan to study healthy breast-feeding women 20 - 45 yrs, between 3 - 5 months lactation and 6 - 8 months lactation. We will use the indicator amino acid oxidation technique (IAAO), which is a modern, quick and safe research method.

详细描述

Purpose:

To determine the dietary protein intake requirement in healthy lactating women during the exclusive breast-fed period (3 - 5 months lactation) and during weaning (6 - 8 months lactation).

Hypothesis:

Recent stable isotope-based research using the IAAO technique indicate that current protein intake recommendations are underestimated in adults by ~40 %, in school aged children ~75 % and pregnant women during early and late gestation by ~39 % and ~73 %, respectively.

Therefore we hypothesize that that protein requirements will be increased during both phases of lactation above that of the current recommendations

研究设计

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

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy lactating women
  • With a healthy baby
  • Exclusively breast feeding (3 - 5 months) and are partially breast-feeding women (6 - 8 months) - not supplementing with infant formula

排除标准

  • Women below 20 yrs or above 45 yrs of age
  • Women who are breast-feeding more than one child
  • Women who are not exclusively breast feeding (3 - 5 months) and women who are supplementing with infant formula or have not transitioned to solid foods by 6 - 8 months.
  • Women not in good health and have a metabolic, neurological, genetic, or immune disorder.
  • Women who are claustrophobic (we will place a clear hood, which can easily be removed, over the participants head for approximately 20 min to measure energy expenditure).
  • Women who are substance dependent (i.e. alcohol, cigarette, illicit drugs)
  • Women who are allergic to eggs and egg protein
  • Women who do not have a healthy baby

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

Principal investigator

University of British Columbia

研究点 (2)

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