Fatty Acid DesaturasesNCT03842891
Genetic Variants Modulate Association Between Dietary n-3 LCPUFAs and DHA Proportion in Breast Milk
An observational study of Fatty Acid Desaturases and Polymorphism, Single Nucleotide, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fatty Acid Desaturases, Polymorphism, Single Nucleotide, Milk, Human
- How many people
- 193 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Sep 2017to 25 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Of all 193 participants, there were 180 who continued to track for two months.
Who may be able to join
- Han Chinese women
- Full-term pregnancy(>36weeks)
- 20-40 years old
- Healthy
- Breast feed their baby for at least 2 months
Who cannot join
- Death before and after childbirth
- Child with congenital disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start25 Sep 2017
- Primary completion25 Sep 2018
- Study completion25 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fatty Acid DesaturasesStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pei-Min Chao, PhD, Principal investigator, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842891
- Sponsor's protocol ID
- CMUH106-REC1-115
- Status last verified
- Feb 2019
- First submitted
- 14 Feb 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32093185
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Variants Modulate Association Between Dietary n-3 LCPUFAs and DHA Proportion in Breast Milk
- ClinicalTrials.gov ID
- NCT03842891
- Acronym / sponsor ID
- CMUH106-REC1-115
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 25 Sep 2018 (actual)
- Study completion
- 25 Sep 2018 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Of all 193 participants, there were 180 who continued to track for two months.
Key inclusion criteria (5 listed)
- Han Chinese women
- Full-term pregnancy(>36weeks)
- 20-40 years old
- Healthy
- Breast feed their baby for at least 2 months
Key exclusion criteria (2 listed)
- Death before and after childbirth
- Child with congenital disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Breast milk fatty acid composition
Time frame: 2 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 32093185Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pei-Min Chao, PhD principal investigator
China Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatty Acid Desaturases and Polymorphism, Single Nucleotide, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast milk fatty acid composition (time frame: 2 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03842891, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.