Tokyo, June 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061887) titled 'A single-center randomized controlled trial evaluating the effect of perinatal maternal dietary intervention on child neurodevelopment' on June 13.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - The Jikei University School of Medicine

Condition: Condition - Pregnant women in late pregnancy to one month postpartum and their infants Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Aim1:To investigate whether a perinatal dietary intervention with appropriate intake of carbohydrates,lipids,vitamins,and minerals specifically a low fat diet centered on rice and mixed grains,miso soup,fish and seafood,soy products,mushrooms,vegetables,fruits,seaweed,and dairy products promotes infant neurodevelopment,assessed primarily using the Ages and Stages Questionnaires,Third Edition (ASQ-3). In addition, we aim to examine whether the intervention improves language development assessed by the Japanese version of the MacArthur Communicative Development Inventories(CDI) and reduces the Modified Checklist for Autism in Toddlers (M-CHAT) as secondary outcomes.

Aim 2:To investigate the effects of maternal dietary patterns during the perinatal period, mode of delivery, and exposure to antibiotics on the establishment of the infant gut microbiota.

Aim 3:To investigate how maternal diet affects infant neurodevelopment through breast milk composition and gut microbiota, including analyses by delivery mode and multi-omics approaches.

Aim 4:To identify biomarkers associated with child neurodevelopment by collecting cord blood samples and conducting multi-omics analyses. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants will receive dietary guidance from late pregnancy to one month postpartum, encouraging a diet centered on rice and mixed grains, miso, seafood, green and yellow vegetables, seaweed, soy products, fruits, and mushrooms, while limiting processed meats, fried foods, beef and pork, commercially prepared side dishes, and eating out. During hospitalization, the use of processed meats will be avoided, and elemental formula will be used when supplementing breast milk with infant formula. Interventions/Control_2 - No restriction group During hospitalization, the use of processed meats will be avoided, and elemental formula will be used when supplementing breast milk with infant formula.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1.Planned delivery at the Maternal and Perinatal Center of The Jikei University Hospital. 2.Residence within Tokyo's 23 wards and ability to attend follow-up visits at the pediatric outpatient clinic of the Maternal and Perinatal Center of The Jikei University Hospital for health checkups or vaccinations until 18 months of age. Even if continued visits become difficult,communication via email must be possible. 3.The mother has no allergy to rice. Key exclusion criteria - 1.Less than 36 weeks of gestational age 2.Breastfeeding is unavailable by medical reasons 3.Having serious conditions needing admission to NICU 4.Having some conditions needing admission to GCU and charged pediatrician judged the infant hard to participate in this trial. 5.Any other cases in which the principal investigator or study investigators determine that participation in this study is inappropriate. 6.Withdrawal of consent. 7.Strong preference for assignment to the intervention group. Target Size - 120

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 20 Day Date of IRB - 2025 Year 11 Month 20 Day Anticipated trial start date - 2026 Year 06 Month 13 Day Last follow-up date - 2030 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070800

Disclaimer: Curated by HT Syndication.