Differential Cognitive Effects of DHA-Enriched and Standard Phosphatidylserine Formulations in Children With ADHD: A Randomized Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in Attention and Executive Function Scores (MOXO and Stroop Tests)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants, investigators, and outcome assessors were blinded to group assignments. Placebo and active formulations were identical in appearance and administration.
入排标准
- 年龄范围
- 10 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 10-14 years
- •Diagnosis of ADHD according to DSM-5 criteria or clinically significant subthreshold ADHD symptoms
- •Medication-naïve status
- •Ability to complete cognitive assessments (MOXO d-CPT and Stroop test)
- •Informed consent obtained from parents or legal guardians
排除标准
- •Presence of psychiatric disorders requiring pharmacological treatment (e.g., major depressive disorder, severe anxiety disorders, autism spectrum disorder)
- •Neurological or sensory impairments affecting test performance
- •Use of cognitive-enhancing supplements (e.g., omega-3, phosphatidylserine, citicoline) within the previous 8 weeks
- •Severe ADHD requiring immediate pharmacological treatment
研究组 & 干预措施
Placebo Group
Participants received placebo once daily for 8 weeks.
干预措施: Placebo (Other)
PS Capsule Group
Participants received phosphatidylserine capsule with DHA once daily for 8 weeks.
干预措施: Phosphatidylserine-Omega3 (Dietary Supplement)
PS Sachet Group
Participants received phosphatidylserine sachet without DHA once daily for 8 weeks.
干预措施: Phosphatidylserine-Omega3 (Dietary Supplement)
PS Plus Group
Participants received higher-dose phosphatidylserine with DHA once daily for 8 weeks.
干预措施: DHA Omega-3 (Dietary Supplement)
结局指标
主要结局
Change in Attention and Executive Function Scores (MOXO and Stroop Tests)
时间窗: Baseline and 8 weeks
Change from baseline to 8 weeks in cognitive performance assessed using the MOXO continuous performance test (attention, impulsivity, timing, and hyperactivity domains) and the Stroop test (reaction time, error rates, and correction counts).
次要结局
- Change in MOXO Attention Score(Baseline and 8 weeks)
- Change in MOXO Impulsivity Score(Baseline and 8 weeks)
- Change in MOXO Hyperactivity Score(Baseline and 8 weeks)
- Change in Stroop Reaction Time(Baseline and 8 weeks)
- Change in Stroop Error Scores(Baseline and 8 weeks)
- Change in Stroop Correction Counts(Baseline and 8 weeks)
研究者
Çağlar Charles Daniel Jaicks
Assist. Prof. Dr.
Istanbul Aydın University