- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06111378
Effect of OMEGA 3 Fatty Acids on Lactation Period
A Comparative Investigation of the Effects of OMEGA 3 Fatty Acids on Lactation
The World Health Organization (WHO) and the United Nations Children's Fund (UNICEF)
recommend that babies be exclusively breastfed for the first 6 months from birth. The composition of breast
milk is dynamic and may vary according to the content of maternal nutrition. Maternal nutrition, on the other
hand, determines the quality of breast milk necessary for the adequate growth and health of infants. For this
reason, the content of the maternal diet is important during the lactation period, which is the critical stage that
can affect the development of infants.
Omega 3 fatty acids are essential unsaturated fatty acids that are not synthesized by the human body and must be obtained through diet. The polyunsaturated fatty acids (PUFAs) most abundant in the diet are short-chain omega 3 alpha linolenic acid (ALA) and omega 6 linoleic acid (LA), which are mostly found in vegetable oils. ALA is a plant-derived omega 3 fatty acid found in flaxseed, walnut, canola and soybean oils. Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are found in marine sources such as seafood and fish oils. Today, the use of Omega 3 fatty acid supplements is increasing during the lactation period. However, consumption of omega 3 fatty acid sources during pregnancy or lactation is thought to be an important factor in preventing cancer risk. In our study, the investigators aimed to compare the maternal diet and the consumption of fish oil, flaxseed oil and walnut oil supplements during the lactation period, to compare the amount of prolactin and DHA in the milk composition and to compare the protective effects against breast cancer with cancer stem cell markers. For this study, 32 healthy Wistar pregnant rats, weighing 200-250 g, 8-10 weeks pregnant and not included in any experiments, will be used. Supplementary oils will be administered by oral gavage, considering the 0.5 g/kg body weight of the pregnant rats according to the groups they are assigned to, during the entire standard lactation period (day 21), considering the day of birth of the pregnant rats as the 0th day of lactation. Mother rats will be sacrificed under anesthesia at the end of the 21st day of lactation, mammary tissues will be taken into appropriate solutions and histopathological and immunohistochemical examinations will be performed. In addition, cardiac blood will be drawn and blood and tissue biochemical analyzes will be performed.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Mani̇sa
-
Yunusemre, Mani̇sa, Turkey
- Manisa Celal Bayar University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- healthy rats
Exclusion Criteria:
- patient rats
- rats that cannot be gavaged
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1:
control group (n:7)
|
|
|
Group 2:
fish oil group (n:7)
|
fish oil
|
|
Group 3:
linseed oil group (n:7)
|
linseed oil
|
|
Group 4:
walnut oil group (n:7)
|
walnut oil
|
|
Group 5:
sham group (non-lactating rats) (n:4)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Analysis of the Effects of OMEGA 3 Fatty Acids on Lactation
Time Frame: Baseline
|
A Comparative Investigation of the maternal diet and the consumption of fish oil, flaxseed oil and walnut oil supplements during the lactation period.
A Comparative Investigation of amount of prolactin and DHA in the milk composition and to compare the protective effects against breast cancer with cancer stem cell markers.
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MCBU_lactation
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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