Effect of OMEGA 3 Fatty Acids on Lactation Period

Sponsor
Celal Bayar University (Other)
Overall Status
Completed
CT.gov ID
NCT06111378
Collaborator
(none)
32
1
14.5
2.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: fish oil
  • Dietary Supplement: linseed oil
  • Dietary Supplement: walnut oil

Study Design

Study Type:
Observational
Actual Enrollment :
32 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
A Comparative Investigation of the Effects of OMEGA 3 Fatty Acids on Lactation
Actual Study Start Date :
Jun 15, 2022
Actual Primary Completion Date :
Dec 17, 2022
Actual Study Completion Date :
Aug 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Group 1:

control group (n:7)

Group 2:

fish oil group (n:7)

Dietary Supplement: fish oil
fish oil

Group 3:

linseed oil group (n:7)

Dietary Supplement: linseed oil
linseed oil

Group 4:

walnut oil group (n:7)

Dietary Supplement: walnut oil
walnut oil

Group 5:

sham group (non-lactating rats) (n:4)

Outcome Measures

Primary Outcome Measures

  1. Analysis of the Effects of OMEGA 3 Fatty Acids on Lactation [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Weeks to 10 Weeks
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • healthy rats
Exclusion Criteria:
  • patient rats

  • rats that cannot be gavaged

Contacts and Locations

Locations

Site City State Country Postal Code
1 Manisa Celal Bayar University Yunusemre Manì‡sa Turkey

Sponsors and Collaborators

  • Celal Bayar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hayrunnisa Yesil Sarsmaz, Asistant Prof., Celal Bayar University
ClinicalTrials.gov Identifier:
NCT06111378
Other Study ID Numbers:
  • MCBU_lactation
First Posted:
Nov 1, 2023
Last Update Posted:
Nov 1, 2023
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hayrunnisa Yesil Sarsmaz, Asistant Prof., Celal Bayar University

Study Results

No Results Posted as of Nov 1, 2023