跳至主要内容
临床试验/NCT01288313
NCT01288313已完成不适用

Effect of N-3 Polyunsaturated Fatty Acids Supplementation on the Human Milk Composition of Lactating Women: Nutritional Intervention With Rapeseed Oil and n-3 Margarine Compared to Standard Olive Oil

University Hospital, Bordeaux8 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2011年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
82
试验地点
8
主要终点
Acide linolenic 18 :3 n-3 analysis measured at day 30, compared to day 15

研究概览

简要总结

We propose to measure the LCPUFA human milk (linolenic acid, linoleic acid, docosahexaenoic acid, arachidonic acid) according to fatty acids nature and quantities consumed by lactating women

详细描述

n-3 and n-6 long chain polyunsaturated fatty acids (LCPUFA) are essential particularly to neurodevelopment of newborn infants. Many variations in essential PUFA and LCPUFA content of human milk are observed according to countries and dietary habits of the mothers.

Maternal diet supplementation of LCPUFA of lactating women may increase LCPUFA human milk according to consensus recommendations.

This clinical trial is performed to evaluate the effect of different of consumption of n-3 fatty acids (linolenic acid) in different forms (oils or margarine) in the human milk composition.

Each diet will last 30 days. During the first period of 15 days, the mothers will receive mediterranean diet based on olive oil. Then, lactating women will be randomised into four groups : one group will receive olive oil (standard group), one group supplemented in rapeseed oil, one group with n-3 margarine and one group with diet associating rapeseed oil and n-3 margarine.Human milk will be collected during the first breastfeeding of the day (10 ml) at three times : Days 0 corresponding to the usual diet , at day 15 after the Mediterranean diet and at day 30, after the study diet.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Lactating women more than 1 month and less than 4 month with neonate whom term is between 37 and 42 gestational age
  • Women who agree to consume fatty fish two times per week
  • Free consent

排除标准

  • Women with multiple infants
  • Chronic treatments more than 8 days
  • Women with treatment during supplementation period
  • Women with maternal pathology not compatible with breastfeed

研究组 & 干预措施

n-3 margarine

Experimental

干预措施: nutritional intervention (Dietary Supplement)

Olive oil

Active Comparator

干预措施: nutritional intervention (Dietary Supplement)

rapeseed oil

Experimental

干预措施: nutritional intervention (Dietary Supplement)

n-3 margarine and rapeseed oil

Experimental

干预措施: nutritional intervention (Dietary Supplement)

结局指标

主要结局

Acide linolenic 18 :3 n-3 analysis measured at day 30, compared to day 15

时间窗: 30 days

次要结局

  • Analysis of linolenic acid and linoleic acid ratio(30 days)
  • Analysis of arachidonic acid, docosahexanoic acid and their ratio(30 days)
  • Comparison of fatty acid composition of human milk before and after supplementation(30 days)
  • Analysis of trans fatty acids according diets(30 days)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (8)

Loading locations...

相似试验