Effectiveness of Neuroplasticity-Targeted Supplements on Neuroinflammatory Markers, ADHD Symptom Severity, and Clinical Scores in Children
Effectiveness of Neuroplasticity-Targeted Supplements on Neuroinflammatory Markers, ADHD Symptom Severity, and Clinical Scores in Children: A Randomized Controlled Trial
연구 개요
상태
상세 설명
Attention Deficit Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder characterized by inattention, hyperactivity, and impulsivity. Emerging evidence suggests that neuroinflammation, altered gut microbiota, and impaired neuroplasticity may contribute to ADHD pathophysiology. Nutritional interventions that target these mechanisms may provide additional therapeutic benefit.
This study is a randomized, placebo-controlled, parallel-group clinical trial designed to investigate whether supplementation with prebiotics, probiotics, omega-3 fatty acids, and vitamin B1 can improve ADHD symptoms and related biological markers in children. Sixty-eight participants aged 6 to 12 years with DSM-5 confirmed ADHD will be enrolled and randomly assigned in equal numbers to one of four intervention groups: (1) prebiotics plus probiotics, (2) omega-3 fatty acids plus vitamin B1, (3) combined supplementation, or (4) placebo.
The intervention duration will be 12 weeks. ADHD symptoms and behavioral scores will be assessed at baseline and after treatment using validated rating scales, including Conners 3 and Vanderbilt ADHD forms. Blood samples will be collected at baseline and week 12 for measurement of inflammatory and neuroplasticity biomarkers, including interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-alpha), brain-derived neurotrophic factor (BDNF), short-chain fatty acids (SCFA), Claudin-5, and complete blood count parameters.
The primary objective is to determine the effect of supplementation on ADHD symptom scores. Secondary objectives include comparison of treatment groups for biomarker changes and evaluation of associations between biological markers and clinical outcomes. Results may help identify safe adjunctive nutritional strategies for children with ADHD.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Dr Dur E Shawar, PhD*
- 전화번호: 03348405894
- 이메일: shehwar88@gmail.com
연구 연락처 백업
- 이름: Prof Dr Inayat Shah, PhD
- 전화번호: 03321431414
- 이메일: inayat.shah@kmu.edu.pk
연구 장소
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KPK
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Peshawar, KPK, 파키스탄, 25000
- 모병
- Khyber Teaching Hospital
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연락하다:
- Dr Dur e
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연락하다:
- Dr Inayat Khan
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- DSM-5 confirmed ADHD diagnosis
- Age 6-12 years
- Medication-free or on stable stimulant medication (≥1 month)
Exclusion Criteria:
- Antibiotic use in last 4 weeks
- Gastrointestinal disorders
- Neurological comorbidities (e.g., epilepsy)
- Severe food allergies
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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Participants will receive inulin powder 6 grams orally once daily for 12 weeks as a prebiotic supplement intended to support beneficial gut microbiota.
다른 이름들:
Participants will receive a probiotic supplement containing Acidophilus Bifidus 2 × 10^11 CFU orally once daily for 12 weeks.
다른 이름들:
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실험적: 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.
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Participants will receive omega-3 fatty acid supplementation containing EPA 650 mg and DHA 540 mg orally once daily for 12 weeks.
다른 이름들:
Participants will receive thiamine (vitamin B1) 10 mg orally once daily for 12 weeks.
다른 이름들:
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실험적: 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.
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Participants will receive inulin powder 6 grams orally once daily for 12 weeks as a prebiotic supplement intended to support beneficial gut microbiota.
다른 이름들:
Participants will receive a probiotic supplement containing Acidophilus Bifidus 2 × 10^11 CFU orally once daily for 12 weeks.
다른 이름들:
Participants will receive omega-3 fatty acid supplementation containing EPA 650 mg and DHA 540 mg orally once daily for 12 weeks.
다른 이름들:
Participants will receive thiamine (vitamin B1) 10 mg orally once daily for 12 weeks.
다른 이름들:
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위약 비교기: Placebo Group
Participants will receive matching placebo supplements orally for 12 weeks.
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Participants will receive matching placebo supplementation orally once daily for 12 weeks.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Parent and Teacher ADHD Rating
기간: Baseline and Week 12
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Change in Attention-Deficit/Hyperactivity Disorder (ADHD) symptom severity measured using the Conners 3 Parent and Teacher ADHD Rating Scales. The Conners 3 assesses inattention, hyperactivity/impulsivity, executive functioning, learning problems, aggression, and peer relations. Raw scores are converted to T-scores, with higher scores indicating greater symptom severity and functional impairment. Scale Information: T-score range: approximately 40-90 Higher scores indicate worse ADHD symptoms. |
Baseline and Week 12
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Neuroinflammation Markers (IL-6, TNF-α)
기간: Baseline and Week 12
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Change in serum levels of pro-inflammatory cytokines interleukin-6 and tumor necrosis factor-alpha measured by ELISA
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Baseline and Week 12
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Neuroplasticity Markers (BDNF, Claudin-5)
기간: Baseline and Week 12
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Change in brain-derived neurotrophic factor (BDNF) and blood-brain barrier tight junction protein claudin-5 measured by ELISA
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Baseline and Week 12
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Short-Chain Fatty Acids (SCFA)
기간: Baseline and Week 12
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Change in gut microbiota-derived metabolites (e.g., butyrate) measured by ELISA
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Baseline and Week 12
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Complete Blood Count (CBC)
기간: Baseline and Week 12
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Change in blood cell counts (e.g., white blood cells, red blood cells, platelets)
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Baseline and Week 12
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ADHD Diagnostic Parent and Teacher Rating
기간: Baseline and Week 12
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Change in ADHD symptom severity measured using the Vanderbilt ADHD Diagnostic Parent and Teacher Rating Scales. The symptom assessment includes 18 ADHD items corresponding to DSM criteria for inattentive and hyperactive-impulsive symptoms. Total symptom scores range from 0 to 54, with higher scores indicating greater ADHD symptom severity. Scale Information: Minimum score: 0 Maximum score: 54 Higher scores indicate worse ADHD symptoms. |
Baseline and Week 12
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공동 작업자 및 조사자
수사관
- 수석 연구원: Dr Dur E Shawar, PhD*, Khyber Medical University Peshawar, Pakistan
- 수석 연구원: Prof Dr Inayat Shah, PhD, Khyber Medical University Peshawar, Pakistan
- 수석 연구원: Prof Dr Omer Malik, PhD, Khyber Medical University Peshawar, Pakistan
- 수석 연구원: Dr Madiha Khattak, PhD, Khyber Medical College
간행물 및 유용한 링크
일반 간행물
- Allahyari P, Abbas Torki S, Aminnezhad Kavkani B, Mahmoudi Z, Mousavi Hoseini MS, Moradi M, Alami F, Keshavarz Mohammadian M, Bahoo Sele Bani S, Abbasi Mobarakeh K, Shafaei H, Khoshdooz S, Hajipour A, Doaei S, Gholamalizadeh M. A systematic review of the beneficial effects of prebiotics, probiotics, and synbiotics on ADHD. Neuropsychopharmacol Rep. 2024 Jun;44(2):300-307. doi: 10.1002/npr2.12437. Epub 2024 Apr 16.
- Levy Schwartz M, Magzal F, Yehuda I, Tamir S. Exploring the impact of probiotics on adult ADHD management through a double-blind RCT. Sci Rep. 2024 Nov 5;14(1):26830. doi: 10.1038/s41598-024-73874-y.
- Yin X, Liu W, Feng H, Huang J, Wang Q, Zhang Q, He J, Wang R. Bifidobacterium animalis subsp. lactis A6 attenuates hippocampal damage and memory impairments in an ADHD rat model. Food Funct. 2024 Mar 4;15(5):2668-2678. doi: 10.1039/d3fo04665f.
- Checa-Ros A, Jerez-Calero A, Molina-Carballo A, Campoy C, Munoz-Hoyos A. Current Evidence on the Role of the Gut Microbiome in ADHD Pathophysiology and Therapeutic Implications. Nutrients. 2021 Jan 16;13(1):249. doi: 10.3390/nu13010249.
- Sayed SZ, Hassan ZO, Abdelraheem WM, Refaat RS, Abuelela IS. Is there a link between peripheral inflammation and blood brain barrier integrity in children with attention-deficit/hyperactivity disorder? A case-control study. BMC Pediatr. 2024 Nov 26;24(1):769. doi: 10.1186/s12887-024-05254-4.
- Steckler R, Magzal F, Kokot M, Walkowiak J, Tamir S. Disrupted gut harmony in attention-deficit/hyperactivity disorder: Dysbiosis and decreased short-chain fatty acids. Brain Behav Immun Health. 2024 Jul 27;40:100829. doi: 10.1016/j.bbih.2024.100829. eCollection 2024 Oct.
- Young GS, Conquer JA, Thomas R. Effect of randomized supplementation with high dose olive, flax or fish oil on serum phospholipid fatty acid levels in adults with attention deficit hyperactivity disorder. Reprod Nutr Dev. 2005 Sep-Oct;45(5):549-58. doi: 10.1051/rnd:2005045.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 신경계 질환
- 정신 질환
- 병리학적 과정
- 염증
- 신경 발달 장애
- 주의력 결핍 및 파괴적 행동 장애
- 병리학적 상태, 징후 및 증상
- 신경 염증성 질환
- 과잉 행동을 동반한 주의력 결핍 장애
- 황 화합물
- 유기 화학 물질
- 이종 사이 클릭 화합물, 1- 링
- 이종 사이 클릭 화합물
- 지방산
- 지질
- 티아 졸
- Azoles
- 식이 보조제
- 음식
- 다이어트, 음식 및 영양
- 생리 학적 현상
- 음식과 음료
- 식이 탄수화물
- 탄수화물
- 피리 미딘
- 중합체
- 거대 분자 물질
- 다당류
- 녹말
- 글루칸
- 지방산, 불포화
- 바이오 폴리머
- 과당
- 유화
- 식이 지방
- 지방
- 식이 지방, 불포화
- 티아민
- 프로바이오틱스
- 이눌린
- 생선 기름
- 지방산, 오메가 -3
기타 연구 ID 번호
- KMU/DIR/CTU/2026/02
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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