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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Group | Placebo Comparator | Participants received placebo once daily for 8 weeks. |
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| PS Capsule Group | Experimental | Participants received phosphatidylserine capsule with DHA once daily for 8 weeks. |
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| PS Sachet Group | Experimental | Participants received phosphatidylserine sachet without DHA once daily for 8 weeks. |
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| PS Plus Group | Experimental | Participants received higher-dose phosphatidylserine with DHA once daily for 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Placebo formulation identical in appearance and administration to active supplements. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Attention and Executive Function Scores (MOXO and Stroop Tests) | 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). | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in MOXO Attention Score | Change from baseline to 8 weeks in attention performance measured by MOXO d-CPT. | Baseline and 8 weeks |
| Change in MOXO Impulsivity Score | Change from baseline to 8 weeks in impulsivity measured by MOXO d-CPT. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Aydin University, Department of Child and Adolescent Psychiatry, Istanbul, Turkey | Istanbul | Istanbul | 34295 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010718 | Phosphatidylserines |
| ID | Term |
|---|---|
| D020404 | Glycerophospholipids |
| D010712 | Phosphatidic Acids |
| D005994 | Glycerophosphates |
| D010743 | Phospholipids |
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Participants were randomly assigned to one of four parallel groups receiving placebo or different phosphatidylserine formulations, with or without DHA, and followed over an 8-week intervention period.
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Participants, investigators, and outcome assessors were blinded to group assignments. Placebo and active formulations were identical in appearance and administration.
| Phosphatidylserine-Omega3 | Dietary Supplement | Capsule containing 100 mg phosphatidylserine and 17.78 mg DHA administered once daily for 8 weeks. |
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| Phosphatidylserine-Omega3 | Dietary Supplement | Sachet formulation containing 117.78 mg phosphatidylserine without DHA administered once daily for 8 weeks. |
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| DHA Omega-3 | Dietary Supplement | Capsule containing 150 mg phosphatidylserine and 26.67 mg DHA administered once daily for 8 weeks. |
|
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| Baseline and 8 weeks |
| Change in MOXO Hyperactivity Score | Change from baseline to 8 weeks in hyperactivity measured by MOXO d-CPT. | Baseline and 8 weeks |
| Change in Stroop Reaction Time | Change from baseline to 8 weeks in reaction time measured by the Stroop test. | Baseline and 8 weeks |
| Change in Stroop Error Scores | Change from baseline to 8 weeks in error rates measured by the Stroop test. | Baseline and 8 weeks |
| Change in Stroop Correction Counts | Change from baseline to 8 weeks in correction counts measured by the Stroop test. | Baseline and 8 weeks |
| D008563 |
| Membrane Lipids |
| D008055 | Lipids |