Postpartum Depression (PPD)NCT07887178
Methyl Donor-Rich Diet in the Postpartum Period
A study testing Methyl Donor-Rich Dietary Intervention in people with Postpartum Depression (PPD) and Breastfeeding, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of a methyl-donor-rich diet during the postpartum period on maternal depression, breastfeeding success, and infant weight. Postpartum women will first complete a three-day dietary record to assess their intake of selected nutrients involved in one-carbon metabolism, including… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Postpartum Depression (PPD), Breastfeeding, Maternal Nutrition
- What is being tested?
- Methyl Donor-Rich Dietary Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 May 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-40 years.
- Women presenting within the first 15 days after delivery.
- Mothers who had a term delivery (≥37 completed weeks of gestation).
- Mothers who are breastfeeding and whose infants are exclusively breastfed.
- No diagnosed psychiatric disorder or related medication use.
- No use of dietary supplements, including omega-3 supplements.
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- No special diet program.
- No history of gestational diabetes, type 1 or type 2 diabetes, or insulin resistance.
- No malabsorption-related disorders, such as celiac disease or Crohn's disease.
- At least one assessed methyl donor nutrient intake below two-thirds of the applicable recommended intake, based on a 3-day dietary record.
- Willingness to participate voluntarily.
Who cannot join
- Development of serious postpartum complications, such as postpartum hemorrhage or sepsis.
- A maternal or infant health condition requiring prolonged hospitalization.
- Introduction of complementary foods to the infant during the study.
- Maternal smoking or alcohol use.
- Failure to adhere to the dietary intervention.
- Failure to attend follow-up assessments or voluntary withdrawal from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Orhaneli Merkez Aile Sağlığı Merkezi
Bursa, Orhaneli̇, 16000
Gurbet İstik, +905436682893, istikgurbet@ogr.iuc.edu.tr
About this study
Official title: The Effect of a Methyl Donor-Rich Diet in the Postpartum Period on Maternal Depression Levels, Breastfeeding Success and Infant Weight: A Randomized Controlled Trial
This study aims to evaluate the effects of a methyl-donor-rich diet during the postpartum period on maternal depression, breastfeeding success, and infant weight.
Postpartum women will first complete a three-day dietary record to assess their intake of selected nutrients involved in one-carbon metabolism, including folate, choline, betaine, methionine, vitamin B6, and vitamin B12. Women whose intake of at least one of these nutrients is below two-thirds of the applicable reference intake and who meet the other eligibility criteria will be eligible to participate.
Read more
Eligible participants will be randomly assigned to one of two groups. The intervention group will receive an individualized methyl-donor-rich dietary program and nutrition education for two months. The control group will receive standard postpartum care and routine dietary advice.
The study will compare the groups in terms of maternal depressive symptoms, breastfeeding success, and infant weight. Dietary intake will also be assessed.
Read the detailed description
Postpartum depression is an important public health concern that can affect maternal well-being, breastfeeding, infant care, and early mother-infant bonding. Nutrition is a potentially modifiable factor that may influence maternal mental health during the postpartum period. Folate, vitamin B6, vitamin B12, choline, betaine, and methionine are involved in one-carbon metabolism and may contribute to biological processes relevant to maternal health.
However, studies evaluating the effects of methyl-donor-rich nutrition during the postpartum period on maternal depression and breastfeeding outcomes remain limited. This randomized controlled trial aims to address this gap by evaluating the effects of a methyl-donor-rich dietary intervention on maternal postpartum depression, breastfeeding success, and infant weight.
The study will be conducted at Orhaneli Merkez Aile Sağlığı Merkezi in Bursa, Türkiye. The planned sample size is 100 postpartum women, with 50 participants allocated to the intervention group and 50 to the control group. The sample size was determined using a power analysis with a significance level of 0.05, statistical power of 80%, and an assumed effect size of Cohen's d = 0.60. The minimum required sample size was calculated as 44 participants per group and increased to 50 per group to account for potential losses to follow-up.
Before randomization, participants' dietary intake will be assessed using a three-day dietary record. Daily intakes of folate, choline, betaine, methionine, vitamin B6, and vitamin B12 will be evaluated in relation to the applicable reference intake values. Women whose intake of at least one of these nutrients is below two-thirds of the applicable reference intake and who meet the other eligibility criteria will be eligible for randomization.
Eligible participants will be randomly assigned in a 1:1 ratio to the intervention group or the control group. The intervention group will receive an individualized methyl-donor-rich dietary program and nutrition education for two months. The intervention will focus on increasing the intake of foods rich in the selected nutrients through dietary modification, without the use of supplements. Kitchen scales will be provided to support portion-size education.
The control group will receive standard postpartum care and routine dietary advice.
Maternal postpartum depression will be assessed using the Edinburgh Postnatal Depression Scale (EPDS). Breastfeeding success will be evaluated using the LATCH breastfeeding assessment tool, and infant weight will be assessed according to the study protocol.
The study hypothesizes that mothers receiving the methyl-donor-rich dietary intervention will have lower postpartum depression scores, higher breastfeeding success scores, and more favorable infant weight outcomes than mothers in the control group.
- Being tested
- Methyl Donor-Rich Dietary Intervention
- Keywords
- Methyl Donors, Methyl Donors-Rich Diet, Postpartum Period, Maternal Depression, Breastfeeding Success, Infant Weight, Randomized Controlled Trial
- Medical subject headings
- Depression, Postpartum, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methyl Donor-Rich Dietary InterventionBehavioural
An individualized methyl-donor-rich dietary program and nutrition education will be provided for two months. The intervention will focus on increasing the dietary intake of folate, choline, betaine, methionine, vitamin B6, and vitamin B12 through food-based dietary modifications without supplementation. Kitchen scales will be provided to support portion-size education.
| Study group | Role | What they receive |
|---|---|---|
| Methyl Donor-Rich Dietary Intervention Group | Experimental | Participants will receive an individualized methyl-donor-rich dietary program and nutrition education for two months, focusing on increasing the intake of foods rich in folate, choline, betaine, methionine, vitamin B6, and vitamin B12 through dietary modification without supplements. Receives: Behavioral: Methyl Donor-Rich Dietary Intervention |
| Control Group | No intervention | Participants will receive standard postpartum care and routine dietary advice without the individualized methyl-donor-rich dietary intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum Depression Level (EPDS Score)
Maternal postpartum depression level will be assessed using the Edinburgh Postnatal Depression Scale (EPDS). The total EPDS score will be used to evaluate depressive symptoms, with higher scores indicating more severe symptoms.
Measured: At baseline and after 8 weeks of dietary intervention.
Breastfeeding Success (LATCH Score)
Breastfeeding success will be assessed using the LATCH breastfeeding assessment tool. The total LATCH score will be used to evaluate breastfeeding effectiveness.
Measured: At baseline and after 8 weeks of dietary intervention.
Infant Weight
Infant weight will be measured in kilograms and compared between the intervention and control groups.
Measured: At baseline and after 8 weeks of dietary intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start21 May 2026
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Depression (PPD)Studies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups: a methyl-donor-rich dietary intervention group or a control group receiving standard postpartum care.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gurbet Istik, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887178
- Sponsor's protocol ID
- 2026/119
- Status last verified
- Sep 2026
- First submitted
- 15 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Methyl Donor-Rich Diet in the Postpartum Period on Maternal Depression Levels, Breastfeeding Success and Infant Weight: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07887178
- Acronym / sponsor ID
- 2026/119
- Keywords
- Methyl Donors, Methyl Donors-Rich Diet, Postpartum Period, Maternal Depression, Breastfeeding Success, Infant Weight, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 21 May 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Oct 2026 (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.
This study aims to evaluate the effects of a methyl-donor-rich diet during the postpartum period on maternal depression, breastfeeding success, and infant weight.
Postpartum women will first complete a three-day dietary record to assess their intake of selected nutrients involved in one-carbon metabolism, including folate, choline, betaine, methionine, vitamin B6, and vitamin B12. Women whose intake of at least one of these nutrients is below two-thirds of the applicable reference intake and who meet the other eligibility criteria will be eligible to participate.
Eligible participants will be randomly assigned to one of two groups. The intervention group will receive an individualized methyl-donor-rich dietary program and nutrition education for two months. The control group will receive standard postpartum care and routine dietary advice.
The study will compare the groups in terms of maternal depressive symptoms, breastfeeding success, and infant weight. Dietary intake will also be assessed.
Detailed description
Postpartum depression is an important public health concern that can affect maternal well-being, breastfeeding, infant care, and early mother-infant bonding. Nutrition is a potentially modifiable factor that may influence maternal mental health during the postpartum period. Folate, vitamin B6, vitamin B12, choline, betaine, and methionine are involved in one-carbon metabolism and may contribute to biological processes relevant to maternal health.
However, studies evaluating the effects of methyl-donor-rich nutrition during the postpartum period on maternal depression and breastfeeding outcomes remain limited. This randomized controlled trial aims to address this gap by evaluating the effects of a methyl-donor-rich dietary intervention on maternal postpartum depression, breastfeeding success, and infant weight.
The study will be conducted at Orhaneli Merkez Aile Sağlığı Merkezi in Bursa, Türkiye. The planned sample size is 100 postpartum women, with 50 participants allocated to the intervention group and 50 to the control group. The sample size was determined using a power analysis with a significance level of 0.05, statistical power of 80%, and an assumed effect size of Cohen's d = 0.60. The minimum required sample size was calculated as 44 participants per group and increased to 50 per group to account for potential losses to follow-up.
Before randomization, participants' dietary intake will be assessed using a three-day dietary record. Daily intakes of folate, choline, betaine, methionine, vitamin B6, and vitamin B12 will be evaluated in relation to the applicable reference intake values. Women whose intake of at least one of these nutrients is below two-thirds of the applicable reference intake and who meet the other eligibility criteria will be eligible for randomization.
Eligible participants will be randomly assigned in a 1:1 ratio to the intervention group or the control group. The intervention group will receive an individualized methyl-donor-rich dietary program and nutrition education for two months. The intervention will focus on increasing the intake of foods rich in the selected nutrients through dietary modification, without the use of supplements. Kitchen scales will be provided to support portion-size education.
The control group will receive standard postpartum care and routine dietary advice.
Maternal postpartum depression will be assessed using the Edinburgh Postnatal Depression Scale (EPDS). Breastfeeding success will be evaluated using the LATCH breastfeeding assessment tool, and infant weight will be assessed according to the study protocol.
The study hypothesizes that mothers receiving the methyl-donor-rich dietary intervention will have lower postpartum depression scores, higher breastfeeding success scores, and more favorable infant weight outcomes than mothers in the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups: a methyl-donor-rich dietary intervention group or a control group receiving standard postpartum care.
| Arm | Type | Receives |
|---|---|---|
| Methyl Donor-Rich Dietary Intervention Group | Experimental | Behavioral: Methyl Donor-Rich Dietary InterventionParticipants will receive an individualized methyl-donor-rich dietary program and nutrition education for two months, focusing on increasing the intake of foods rich in folate, choline, betaine, methionine, vitamin B6, and vitamin B12 through dietary modification without supplements. |
| Control Group | No intervention | –Participants will receive standard postpartum care and routine dietary advice without the individualized methyl-donor-rich dietary intervention. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Women aged 18-40 years.
- Women presenting within the first 15 days after delivery.
- Mothers who had a term delivery (≥37 completed weeks of gestation).
- Mothers who are breastfeeding and whose infants are exclusively breastfed.
- No diagnosed psychiatric disorder or related medication use.
Key exclusion criteria (6 listed)
- Development of serious postpartum complications, such as postpartum hemorrhage or sepsis.
- A maternal or infant health condition requiring prolonged hospitalization.
- Introduction of complementary foods to the infant during the study.
- Maternal smoking or alcohol use.
- Failure to adhere to the dietary intervention.
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 |
|---|---|---|
| Methyl Donor-Rich Dietary InterventionAn individualized methyl-donor-rich dietary program and nutrition education will be provided for two months. The intervention will focus on increasing the dietary intake of folate, choline, betaine, methionine, vitamin B6, and vitamin B12 through food-based dietary modifications without supplementation. Kitchen scales will be provided to support portion-size education. | Behavioural | Methyl Donor-Rich Dietary Intervention Group |
Primary outcome
Postpartum Depression Level (EPDS Score)
Time frame: At baseline and after 8 weeks of dietary intervention.
Maternal postpartum depression level will be assessed using the Edinburgh Postnatal Depression Scale (EPDS). The total EPDS score will be used to evaluate depressive symptoms, with higher scores indicating more severe symptoms.
Breastfeeding Success (LATCH Score)
Time frame: At baseline and after 8 weeks of dietary intervention.
Breastfeeding success will be assessed using the LATCH breastfeeding assessment tool. The total LATCH score will be used to evaluate breastfeeding effectiveness.
Infant Weight
Time frame: At baseline and after 8 weeks of dietary intervention.
Infant weight will be measured in kilograms and compared between the intervention and control groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methyl Donor-Rich Dietary Intervention in people with Postpartum Depression (PPD) and Breastfeeding, run by Istanbul University - Cerrahpasa 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 11 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum Depression Level (EPDS Score) (time frame: At baseline and after 8 weeks of dietary intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2026.