Effectiveness of Neuroplasticity-Targeted Supplements on Neuroinflammatory Markers, ADHD Symptom Severity, and Clinical Scores in Children

Conditions

• Attention Deficit Hyperactivity Disorder

Eligibility Criteria

Sex

ALL

Age

6 Years - 12 Years

Healthy Volunteers

Not accepted

Interventions

• Inulin — DIETARY_SUPPLEMENT
  Participants will receive inulin powder 6 grams orally once daily for 12 weeks as a prebiotic supplement intended to support beneficial gut microbiota.
• Probiotic — DIETARY_SUPPLEMENT
  Participants will receive a probiotic supplement containing Acidophilus Bifidus 2 × 10\^11 CFU orally once daily for 12 weeks.
• Omega-3 Fatty Acids — DIETARY_SUPPLEMENT
  Participants will receive omega-3 fatty acid supplementation containing EPA 650 mg and DHA 540 mg orally once daily for 12 weeks.
• Thiamine — DIETARY_SUPPLEMENT
  Participants will receive thiamine (vitamin B1) 10 mg orally once daily for 12 weeks.
• Placebo — OTHER
  Participants will receive matching placebo supplementation orally once daily for 12 weeks.

Study Details

This randomized controlled trial will evaluate the effectiveness of neuroplasticity-targeted supplements on neuroinflammatory markers and ADHD symptoms in children aged 6 to 12 years diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). Participants will be randomly assigned to one of four groups: gut-targeted supplements (prebiotics and probiotics), brain-targeted supplements (omega-3 fatty acids and vitamin B1), combined supplementation, or placebo. The intervention period will last 12 weeks. Primary outcomes include changes in ADHD symptom severity and clinical scores using validated rating scales. Secondary outcomes include changes in biomarkers of neuroinflammation and neuroplasticity, including IL-6, TNF-alpha, BDNF, short-chain fatty acids, and Claudin-5.

Key Dates

First listed

Jun 24, 2026

Start date

Mar 1, 2026

Status verified

Jun 2026

Primary completion

Nov 30, 2026

Completion

Dec 25, 2026

Study Design

Enrollment

68 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Gut-Targeted Supplements Group
  Participants will receive prebiotics (inulin 6 g/day) and probiotics (Acidophilus Bifidus 2 × 10\^11 CFU/day orally) for 12 weeks.
• Experimental: Neuroplasticity-Targeted Supplements Group
  Participants will receive omega-3 fatty acids containing EPA 650 mg and DHA 540 mg daily, plus vitamin B1 (thiamine 10 mg/day orally) for 12 weeks.
• Experimental: Combined Supplements Group
  Participants will receive prebiotics (inulin 6 g/day), probiotics (Acidophilus Bifidus 2 × 10\^11 CFU/day), omega-3 fatty acids containing EPA 650 mg and DHA 540 mg daily, and vitamin B1 (thiamine 10 mg/day orally) for 12 weeks.
• Placebo Comparator: Placebo Group
  Participants will receive matching placebo supplements orally for 12 weeks.

Primary Outcome Measure

Parent and Teacher ADHD Rating [ Time Frame: Baseline and Week 12 ]

Central Contacts

• Dr Dur E Shawar, PhD*
  03348405894
  [email protected]
• Prof Dr Inayat Shah, PhD
  03321431414
  [email protected]

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