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临床试验/NCT05133466
NCT05133466Unknown不适用

Odour Characteristics of Human Breast Milk of Chinese Mothers

Heilongjiang Feihe Dairy Co. Ltd.1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年9月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
1
主要终点
Odour active compound and their concentrations

研究概览

简要总结

It is well known that breast milk exerts many positive effects on the general health, growth and development of infants. When breastfeeding is not possible, infant formula is considered to be an effective substitute to satisfy the regular nutritional demand of infants. At present, researchers make every effort to simulate the nutritional status of breast milk but mostly neglect the important role that odour plays in guiding the baby to recognize breast milk, promoting the baby's sucking behavior and food intake. The odour changes of the breast milk are so far mainly related to storage, lactational stage and maternal diet. To understand the odour characteristics of the human breast milk from different regions in China, 90 mothers will be recruited from three Chinese cities: Beijing, Chengdu and Wuxi, representing three typical regions with very different climate characteristics and diet habits. The breast milk samples as well as infant formulas will be analyzed using the identical state of the art separation and identification techniques to identify the odorous compounds, determine their concentrations in the breast milk and infant formula as well as determine their importance in contributing to the total odour of samples. The final objective of this study will be to mimic the odour of the breast milk and to understand the difference of breast milk odour from different regions with very different climate and diet composition, as well as to identify the odour deviation of the infant formula from the breast milk. Our results will provide references for the preparation of new infant formula with both nutritional ingredents and odour characteristics simulating that of breast milk.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
25 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Lactating mother aged 25 ~ 35 years
  • Breastfeeding infants (aged 15 ~180 days) and express sufficient breast milk
  • Mother is in good health and has balanced nutrition
  • Mother is non smoker and non alcoholic, no smokers living in the same apartment
  • Voluntarily signed the Informed Consent Form

排除标准

  • Mother or newborn infant has major diseases
  • Mother participating in any other nutritional or pharmaceutical intervention studies recently
  • Other conditions that are not suitable for this study

结局指标

主要结局

Odour active compound and their concentrations

时间窗: Up to 2 years

Gas chromatography-olfactometry/mass spectrometry and other state of the art equipments and protocols will be employed to identify the odour active compounds in the samples, and their concentration and importance in contributing to the odour will be determined.

次要结局

未报告次要终点

研究者

发起方
Heilongjiang Feihe Dairy Co. Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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