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临床试验/NCT03808207
NCT03808207Unknown不适用

Human Milk Lipid Profile Assessment and Influences of Mother's Diet Valutazione Del Profilo Lipidico Del Latte Materno e Della Sua Variazione in Relazione Alla Dieta Materna

Università degli Studi di Ferrara2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年8月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
24
试验地点
2
主要终点
Human milk lipid profile assesment after 3 months of DHA/ALA diet enrichment

研究概览

简要总结

Human milk profile is unique and diet exerts a pivot role in determing its composition.

As a rule, nursing mothers do not receive specific nutritional indications aimed at improving the lipid profile of milk, despite the scientific evidence in favor of the importance of DHA in the infant's diet.

The research aims to determine the effect of a dietary counseling specifically targeted at increasing the intake of fatty acids ω3 (DHA, EPA and ALA) on the lipid profile of breast milk, in order to identify effective and viable nutrition claims for breastfeeding women.

详细描述

Breast milk, with its unique and inimitable characteristics, is the ideal feeding for full-term babies. The maternal diet strongly influences the composition of milk, in particular, its lipid proflie, which provides about 50% of the infant's energy needs. In particular, the polyunsaturated fatty acid fraction may varies according ethnic origin and diet habit.

Docosahexaenoic acid or DHA (22: 6 n-3), a long chain fatty acid from the omega 3 series, plays a fundamental role in neurogenesis and neurotransmission as well as in vision, as it is present in both brain, particularly in neural synapses, and in retinal photoreceptors. In particular, the brain grows rapidly from birth to the first year of life, and this growth must be supported by the adequate and balanced intake of all fatty acids; among these we have seen that DHA has a priority role. Observational studies have shown that higher concentrations in breast milk and / or maternal and / or neonatal DHA blood are associated with greater visual acuity, language development, psychomotor development, attention and higher IQ scores in children. The paucity of DHA in the maternal diet of Western countries, and the low conversion rate of α-linolenic acid or ALA (18: 3 n-3) in DHA in humans babies, may result in an insufficient supply for the newborn brain.

Most of the prospective studies carried out in this area have evaluated the effects of maternal supplementation of fish oils, algal oils, chia oil, linseed oil. At present, the positive association between the frequency of fish consumption and DHA levels in breast milk has only been evaluated in retrospective studies.

On these basis, the purpose of this randomized clinical trial is the evaluation of the efficacy of a dietary counseling specifically aimed at increasing the intake of ALA and its long-chain derivatives on the lipid profile of breast milk. Women in the intervention group will be provided an informative scheme on food options with the highest content of the aforementioned polyunsaturated fatty acids. The expected result, at 3 months after delivery, in the intervention group is an increase of DHA in breast milk 80% higher than the value found in the control group (women on a free diet). Dietary habits at enrollment and actual intakes will be recorded for 1 week before the two milk samplings. The research is also aimed at verifying the efficacy of a nutritional educational intervention, without strict preordained schemes, and above all without the aid of dietary supplements.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

The lipid profile will be assessed by an external investigator who is blind for the dietary advices and choices of the single patient. Milk samples are assigned a progressive numerical code.

入排标准

性别
Female
接受健康志愿者

入选标准

  • women who have delivered at > 33 weeks GA
  • ongoing breastfeeding
  • consent received

排除标准

  • contraindications to breastfeeding
  • neonatal malformations or genetic anomalies
  • language barrier

研究组 & 干预措施

Intervention group

Experimental

Increase of the average intake of dietary DHA: dietary advices concerning the concentration of docosahexaenoic acid (DHA) in several foods; the recommended daily or weekly intake of different food options (animal, vegetal) in order to reach the average intake of 300-350 mg DHA/day

干预措施: Dietary counseling and DHA dietary increase in breastfeeding mothers (Other)

Control group

No Intervention

No specific dietary advice; Only endorsement and promotion of breastfeeding.

结局指标

主要结局

Human milk lipid profile assesment after 3 months of DHA/ALA diet enrichment

时间窗: 80 days

Lipid profile assesment of human milk at 10 days and 3 months after delivery. Evaluation of the effect of DHA/ALA diet enrichment during the study period. Measurement of total fat (g/100 ml), saturated fatty acids, monounsaturated fatty and polyunsaturated fatty acids concentration (mg/100 ml), and specifically LA, ALA, ARA, DHA and EPA concentration (mg/100 ml) will be performed with gas chromatograph coupled to a MS / MS mass spectrometer.

次要结局

  • Lipid profile characteristics in human milk of mothers delivering preterm or term infants(80 days)

研究者

发起方
Università degli Studi di Ferrara
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fanaro Silvia

Assistant Professor

Università degli Studi di Ferrara

研究点 (2)

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