Effect of OMEGA 3 Fatty Acids on Lactation Period

October 26, 2023 updated by: Hayrunnisa Yesil Sarsmaz, Celal Bayar University

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

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Mani̇sa
      • Yunusemre, Mani̇sa, Turkey
        • Manisa Celal Bayar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

pregnant rats unpregnant female rats

Description

Inclusion Criteria:

  • healthy rats

Exclusion Criteria:

  • patient rats
  • rats that cannot be gavaged

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2022

Primary Completion (Actual)

December 17, 2022

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

December 1, 2022

First Submitted That Met QC Criteria

October 26, 2023

First Posted (Actual)

November 1, 2023

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

December 1, 2022

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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