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

NCT ID: NCT03842891

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 193 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-25
• Study Completion Date: 2018-09-25

Brief 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

Fatty Acid Desaturases; Polymorphism, Single Nucleotide; Milk, Human

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Han Chinese women
• Full-term pregnancy(>36weeks)
• 20-40 years old
• Healthy
• Breast feed their baby for at least 2 months

Exclusion Criteria

• Death before and after childbirth
• Child with congenital disease

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pei-Min Chao, PhD

Role: PRINCIPAL_INVESTIGATOR

China Medical University, China

Locations

China Medical University

Taichung, , Taiwan

Countries

Taiwan

References

Wu WC, Lin HC, Liao WL, Tsai YY, Chen AC, Chen HC, Lin HY, Liao LN, Chao PM. FADS Genetic Variants in Taiwanese Modify Association of DHA Intake and Its Proportions in Human Milk. Nutrients. 2020 Feb 20;12(2):543. doi: 10.3390/nu12020543.

Reference Type: DERIVED

PMID: 32093185 (View on PubMed)

Other Identifiers

CMUH106-REC1-115

Identifier Type: -

Identifier Source: org_study_id