NCT07521449

Effects of Phosphatidylserine and DHA on Cognitive Performance in Children With ADHD

Differential Cognitive Effects of DHA-Enriched and Standard Phosphatidylserine Formulations in Children With ADHD: A Randomized Placebo-Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Çağlar Charles Daniel Jaicks · Academic / Other
• Sex: All
• Age: 10 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to evaluate the effects of different phosphatidylserine (PS) formulations, with or without docosahexaenoic acid (DHA), on cognitive performance in children diagnosed with attention-deficit/hyperactivity disorder (ADHD) or presenting with clinically significant subthreshold ADHD symptoms. A total of 45 medication-naïve children aged 10-14 years were randomly assigned to one of four groups: placebo, PS capsule (PS + DHA), PS sachet (PS without DHA), or PS Plus capsule (higher-dose PS + DHA). The intervention period was eight weeks. Cognitive performance was assessed at baseline and after the intervention using the MOXO continuous performance test and the Stroop test. The study aimed to compare the effects of different PS formulations on attention, impulsivity, hyperactivity, and executive function.

Detailed description

This prospective, randomized, placebo-controlled clinical trial was conducted to investigate the cognitive effects of phosphatidylserine-based nutritional supplementation in children with ADHD or clinically significant subthreshold ADHD symptoms. Participants were medication-naïve children aged 10-14 years who were diagnosed based on DSM-5 criteria or clinical evaluation supported by standardized rating scales. Eligible participants were randomly assigned in a 1:1:1:1 ratio to one of four groups: placebo, PS capsule (100 mg phosphatidylserine + 17.78 mg DHA), PS sachet (117.78 mg phosphatidylserine without DHA), or PS Plus capsule (150 mg phosphatidylserine + 26.67 mg DHA). All participants received their assigned intervention once daily for eight weeks. Cognitive outcomes were assessed using the MOXO continuous performance test (MOXO d-CPT), which evaluates attention, impulsivity, timing, and hyperactivity, and the Stroop test, which measures executive function, inhibitory control, and cognitive flexibility. The primary objective of the study was to compare changes in cognitive performance across the different intervention groups. The study was conducted in a single-center clinical setting, and all assessments were performed under standardized conditions. The findings were intended to provide insight into the dose- and formulation-dependent cognitive effects of phosphatidylserine supplementation, particularly in combination with DHA, in pediatric ADHD populations.

Conditions

• Attention Deficit Hyperactivity Disorder (ADHD)
• ADHD

Interventions

Type	Name	Description
OTHER	Placebo	Placebo formulation identical in appearance and administration to active supplements.
DIETARY_SUPPLEMENT	Phosphatidylserine-Omega3	Capsule containing 100 mg phosphatidylserine and 17.78 mg DHA administered once daily for 8 weeks.
DIETARY_SUPPLEMENT	Phosphatidylserine-Omega3	Sachet formulation containing 117.78 mg phosphatidylserine without DHA administered once daily for 8 weeks.
DIETARY_SUPPLEMENT	DHA Omega-3	Capsule containing 150 mg phosphatidylserine and 26.67 mg DHA administered once daily for 8 weeks.

Timeline

• Start date: 2023-12-30
• Primary completion: 2024-06-01
• Completion: 2025-06-01
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: Turkey (Türkiye)