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

NCT03842891 | Completed

• 1 other identifier: CMUH106-REC1-115
• Study Type: observational
• Target: 193
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Breast milk fatty acid composition

  Breast milk will be collected at the end of the 1st and 2nd month of postpartum period.The fatty acid composition in milk will be analyzed by gas chromatography.

  2 month

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Of all 193 participants, there were 180 who continued to track for two months.

You may qualify if:

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

You may not qualify if:

• Death before and after childbirth
• Child with congenital disease

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University

Taichung, 40402, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 32093185 DERIVED

Study Officials

• Pei-Min Chao, PhD

  China Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 15, 2019
• Study Start: September 25, 2017
• Primary Completion: September 25, 2018
• Study Completion: September 25, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

TW (1)