NCT06111378

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2022

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
Last Updated

November 1, 2023

Status Verified

December 1, 2022

Enrollment Period

6 months

First QC Date

December 1, 2022

Last Update Submit

October 26, 2023

Conditions

Keywords

lactationomega 3 fatty acidfish oilflaxseed oilwalnut oilbreast cancer

Outcome Measures

Primary Outcomes (1)

  • Analysis of the Effects of OMEGA 3 Fatty Acids on Lactation

    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

Study Arms (5)

Group 1:

control group (n:7)

Group 2:

fish oil group (n:7)

Dietary Supplement: fish oil

Group 3:

linseed oil group (n:7)

Dietary Supplement: linseed oil

Group 4:

walnut oil group (n:7)

Dietary Supplement: walnut oil

Group 5:

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

Interventions

fish oilDIETARY_SUPPLEMENT

fish oil

Group 2:
linseed oilDIETARY_SUPPLEMENT

linseed oil

Group 3:
walnut oilDIETARY_SUPPLEMENT

walnut oil

Group 4:

Eligibility Criteria

Age8 Weeks - 10 Weeks
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

pregnant rats unpregnant female rats

You may qualify if:

  • healthy rats

You may not qualify if:

  • patient rats
  • rats that cannot be gavaged

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manisa Celal Bayar University

Yunusemre, Mani̇sa, Turkey (Türkiye)

Location

Related Publications (1)

  • Mutlu Durgut I, Yesil Sarsmaz H, Gurgen SG. A Comparative Study on the Effect of Omega-3 Fatty Acids on Lactation. Mol Nutr Food Res. 2026 Jan;70(2):e70393. doi: 10.1002/mnfr.70393.

Biospecimen

Retention: SAMPLES WITH DNA

breast tissues cells

MeSH Terms

Conditions

Breast FeedingBreast Neoplasms

Interventions

Fish OilsLinseed Oil

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

OilsLipidsFats, UnsaturatedFatsPlant OilsPlant PreparationsBiological ProductsComplex Mixtures

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Prof.

Study Record Dates

First Submitted

December 1, 2022

First Posted

November 1, 2023

Study Start

June 15, 2022

Primary Completion

December 17, 2022

Study Completion

August 31, 2023

Last Updated

November 1, 2023

Record last verified: 2022-12

Locations