Methyl Donor-Rich Diet in the Postpartum Period

NCT07887178 | Recruiting

• 1 other identifier: 2026/119
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression (PPD); Breastfeeding; Maternal Nutrition; Infant Development

Keywords

Methyl Donors; Methyl Donors-Rich Diet; Postpartum Period; Maternal Depression; Breastfeeding Success; Infant Weight; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  At baseline and after 8 weeks of dietary intervention.

Study Arms (2)

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.

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.

Interventions

Methyl Donor-Rich Dietary Intervention BEHAVIORAL

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.

Methyl Donor-Rich Dietary Intervention Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Orhaneli Merkez Aile Sağlığı Merkezi

Bursa, Orhaneli̇, 16000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum; Breast Feeding

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 15, 2026
• First Posted: October 21, 2026
• Study Start: May 21, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-09

Locations

TU (1)