Clinical Trials Directory

Trials / Completed

CompletedNCT03842891

Genetic Variants Modulate Association Between Dietary n-3 LCPUFAs and DHA Proportion in Breast Milk

Status
Completed
Phase
Study type
Observational
Enrollment
193 (actual)
Sponsor
China Medical University Hospital · Academic / Other
Sex
Female
Age
20 Years – 40 Years
Healthy volunteers
Accepted

Summary

DHA is important for the development of brain and retina in newborns. Considering that exclusive breast feeding for at least 4 \~6 months are globally recommended, plus it is well known that nutrient requirement is determined by both genetic and environmental (including diet) factors, this clinical study sought to investigate how the DHA levels in maternal milk is modulated by genetic variants and dietary n-3 LCPUFA intake. To recruit subjects (n=193), the inclusion criteria are Han Chinese women just having delivered full-term baby, 20-40 years old, healthy, and willing to breast feed their baby for at least 2 months. Written informed consent will be obtained from participants. Personal information (or covariates) such as height, weight (before getting pregnancy and delivery, respectively), age, parity, education, smoking, alcohol drinking, gender of baby…etc, and DNA from oral swab will be collected. Breast milk and dietary data will be collected at the end of the 1st and 2nd month of postpartum period. Considering Han Chinese women usually have special postpartum diets and care during puerperium, therefore, collection of breast milk and dietary information will be repeated at the 2nd month. The fatty acid composition in milk will be analyzed by gas chromatography. Using food frequency questionnaire, intake of n-3 LCPUFA from foods + fish oil supplements will be calculated. Subjects will be instructed to give a 3-days food record as well. We foresee results of this study might contribute to public health care as nutritionists/dietitians will be able to target the vulnerable subjects, who are dietary dependent for DHA, for dedications in nutrition consults or customized dietary guidance. Moreover, these information are valuable in making policy regarding dietary recommendation in Taiwan.

Conditions

Timeline

Start date
2017-09-25
Primary completion
2018-09-25
Completion
2018-09-25
First posted
2019-02-15
Last updated
2019-02-15

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT03842891. Inclusion in this directory is not an endorsement.