Lactation InducedNCT06111378
Effect of OMEGA 3 Fatty Acids on Lactation Period
An observational study of Lactation Induced, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 10 weeks, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactation Induced
- What is being tested?
- fish oil, linseed oil and walnut oil
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2022to 31 Aug 2023
- 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 8 to 10 weeks
- Women only
- Healthy volunteers accepted
- Child
Study population: pregnant rats unpregnant female rats
Who may be able to join
- healthy rats
Who cannot join
- patient rats
- rats that cannot be gavaged
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Manisa Celal Bayar University
Yunusemre, Mani̇sa
About this study
Official title: 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
Read more
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.
- Conditions
- Lactation Induced
- Being tested
- fish oil, linseed oil, walnut oil
- Keywords
- lactation, omega 3 fatty acid, fish oil, flaxseed oil, walnut oil, breast cancer
- Medical subject headings
- Breast Feeding, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fish oilDietary supplement
fish oil
linseed oilDietary supplement
linseed oil
walnut oilDietary supplement
walnut oil
| Study group | Role | What they receive |
|---|---|---|
| Group 1: | control group (n:7) | |
| Group 2: | fish oil group (n:7) Receives: Dietary Supplement: fish oil | |
| Group 3: | linseed oil group (n:7) Receives: Dietary Supplement: linseed oil | |
| Group 4: | walnut oil group (n:7) Receives: Dietary Supplement: walnut oil | |
| Group 5: | sham group (non-lactating rats) (n:4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start15 Jun 2022
- Primary completion17 Dec 2022
- Study completion31 Aug 2023
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 Lactation InducedStudies of the same condition, open and under way.
- 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hayrunnisa Yesil Sarsmaz, Manisa Celal Bayar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111378
- Sponsor's protocol ID
- MCBU_lactation
- Status last verified
- Dec 2022
- First submitted
- 1 Dec 2022
- Last updated
- 1 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41572962
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Investigation of the Effects of OMEGA 3 Fatty Acids on Lactation
- ClinicalTrials.gov ID
- NCT06111378
- Acronym / sponsor ID
- MCBU_lactation
- Conditions
- Lactation Induced
- Keywords
- lactation, omega 3 fatty acid, fish oil, flaxseed oil, walnut oil, breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 17 Dec 2022 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 1 Nov 2023 (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.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1: | – | –control group (n:7) |
| Group 2: | – | Dietary Supplement: fish oilfish oil group (n:7) |
| Group 3: | – | Dietary Supplement: linseed oillinseed oil group (n:7) |
| Group 4: | – | Dietary Supplement: walnut oilwalnut oil group (n:7) |
| Group 5: | – | –sham group (non-lactating rats) (n:4) |
Who may qualify
- Ages
- 8 to 10 weeks
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- pregnant rats unpregnant female rats
Key inclusion criteria (1 listed)
- healthy rats
Key exclusion criteria (2 listed)
- patient rats
- rats that cannot be gavaged
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fish oilfish oil | Dietary supplement | Group 2: |
| linseed oillinseed oil | Dietary supplement | Group 3: |
| walnut oilwalnut oil | Dietary supplement | Group 4: |
Primary outcome
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.
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 1 Nov 2023.
- Derived from this study: PubMed 41572962Mutlu 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.
Related trials for Lactation Induced
RecruitingObservational study
Birth & Breastfeeding Support Study
Breastfeeding, Breastfeeding Initiation
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lactation Induced, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
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 1 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 1 Nov 2023. 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 Turkey (Türkiye). 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?
Analysis of the Effects of OMEGA 3 Fatty Acids on Lactation (time frame: Baseline). 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 NCT06111378, 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 1 Nov 2023.