Clinical trial NCT03368690: Therapeutic Effects of Pine Bark Extracts in Attention Deficit Hyperactivity Disorder
Official title: Effects of Polyphenolic Extract From Pine Bark on the Inattention and Hyperactivity in Patients With Attention Deficit Hyperactivity Disorder Based on the Antioxidative Status.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Keywords: pine barkextract, antioxidant, ADHD, catecholamine
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 32
Sex: ALL
Minimum age (years): 7
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: In this study, the investigators will investigate the effects of polyphenolic extract from pine bark on the inattention and hyperactivity in patients with attention deficit hyperactivity disorder (ADHD) based on antioxidative status.

Detailed description: Attention deficit hyperactivity disorder (ADHD) is a disorder characterized by developmentally inappropriate levels of impulsive behavior, hyperactivity and/or inattention. It is one of the most prevalent chronic pediatric neurodevelopmental conditions. The pathology of ADHD may relate to the oxidative stress caused by abnormal neurotransmitters. Therefore, we would like to intervene pine bark extract (PE) which can improve the symptom of inattention and hyperactivity from the psychological assessment and antioxidative status.

20 children and adolescent aged above 7 but under 20 years old and 20 adults aged from 20 to 65 years old with ADHD will be enrolled in this randomized, double-blind, cross-over and placebo controlled 10-weeks period experiment.

At the treatment period (0th to 4th week of the experiment), children and adolescent with ADHD will receive 1\~2 placebo or capsules of polyphenolic extract from pine bark (25mg Oligopin per capsule) according to their body weight. On the other hand, adult with ADHD will receive 2\~3 placebo or capsules of polyphenolic extract from pine bark (50mg Oligopin per capsule). The 5th to 6th week will be the washout period. The control group and Oligopin group will be cross-over at 7th week to 10th week of the experiment. Psychiatric examination and nutrition status evaluation will be carried out in this study. At the beginning, 4th, 7th and 10th week of the study, basic psychiatric examination will be carried out by clinical psychologist. Routine laboratory parameter including liver function, kidney function, lipid profile, antioxidative status and iron status will be investigated at the beginning, 4th and 10th week of the study. The nutrition status evaluation including food frequency questionnaire and three-day dietary record (two days on weekdays, one day on holiday). The food frequency questionnaire will be performed at the beginning, 4th, 7th and 10th of the experiment while three-day dietary record will be performed at 2th, 4th , 8th and 10th of the experiment. We expect that polyphenolic extract from pine bark may improve oxidative status which in turn ameliorate the attention and emotional stability in patients with ADHD.

Eligibility criteria: Inclusion Criteria:

1. Children or adolescent with attention deficit hyperactivity disorder (ADHD) whose age reach 7 but under 20 and were not treated with ADHD drugs, antihypertensive drugs and dietary supplements more than 4 weeks.
2. Adults with attention deficit hyperactivity disorder (ADHD) aged from 20 to 65 and were not treated with antihypertensive drugs and dietary supplements more than 4 weeks.

Exclusion Criteria:

1. Children or adolescent treated with ADHD drugs, antihypertensive drugs and dietary supplements
2. Adults treated with antihypertensive drugs and dietary supplements
3. Nervous system diseases (including brain or other central nervous system diseases, e.g. epilepsy)
4. Autism spectrum disorder
5. Intellectual disability
6. Other mental disorders (e.g. Schizophrenia, Bipolar Disorder, Major depressive disorder, Anxiety Disorder, Personality disorders, Conduct disorder, Tourette Syndrome.)
7. Hepatic, renal, gastrointestinal and cardiovascular disorders
8. Biochemical abnormality

Primary outcomes:
measure: Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV)
timeFrame: at the start of the experiment and at the 4th, 7th and 10th week
measure: Adult ADHD Self-Report Scale-V1.1 (ASRS-V1.1) or Individual Subjective Perception Job Stress Scale (ISPJSS)
timeFrame: at the start of the experiment and at the 4th, 7th and 10th week
measure: Conners' Continuous Performance Test (CPT-III)
timeFrame: at the start of the experiment and at the 4th, 7th and 10th week
measure: Wechsler Memory Scale , WMS-III
timeFrame: at the start of the experiment and at the 4th, 7th and 10th week
measure: Wisconsin Card Sorting Test, WCST
timeFrame: at the start of the experiment and at the 4th, 7th and 10th week
Secondary outcomes:
measure: Liver function
timeFrame: at the start of the experiment and at the 4th, 10th week
measure: Kidney function
timeFrame: at the start of the experiment and at the 4th, 10th week
measure: Lipid profile
timeFrame: at the start of the experiment and at the 4th, 10th week
measure: Hematology
timeFrame: at the start of the experiment and at the 4th, 10th week
measure: Iron status
timeFrame: at the start of the experiment and at the 4th, 10th week
measure: Antioxidative status
timeFrame: at the start of the experiment and at the 4th, 10th week
measure: Food frequency questionnaire
timeFrame: at the beginning, 4th, 7th and 10th of the experiment
measure: Three-day dietary record.
timeFrame: at 2nd , 4th, 6th and 10th week of study
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical University - Shuang Ho Hospital
city: Taipei City
country: Taiwan
facility: Taiwan Adventist Hospital
Study officials:
References: