NCT07887178 Methyl Donor-Rich Diet in the Postpartum Period
| NCT ID | NCT07887178 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istanbul University - Cerrahpasa |
| Condition | Postpartum Depression (PPD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-05-21 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2026-05-21 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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.
Frequently Asked Questions
Who can join the NCT07887178 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Postpartum Depression (PPD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07887178 currently recruiting?
Yes, NCT07887178 is actively recruiting participants. Visit ClinicalTrials.gov or contact Istanbul University - Cerrahpasa to inquire about joining.
Where is the NCT07887178 trial being conducted?
This trial is being conducted at Bursa, Turkey (Türkiye).
Who is sponsoring the NCT07887178 clinical trial?
NCT07887178 is sponsored by Istanbul University - Cerrahpasa. The trial plans to enroll 100 participants.
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