Therapeutic Effects of Pine Bark Extracts in Attention Deficit Hyperactivity Disorder

Taipei Medical University

Status: Completed

Conditions: ADHD

Treatments: Dietary Supplement: Oligopin®; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03368690

N201706026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 7 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

32 participants in 2 patient groups, including a placebo group

Oligopin®

Experimental group

Description:

Dietary supplement, Polyphenolic extract from pine bark. This group receives a nutritional supplement for a period of 10 weeks. Children and adolescent 20-50 kg body weight: 25 mg Oligopin®/day; \> 50 kg body weight: 50 mg Oligopin®/day Adults 40-60 kg body weight: 100 mg Oligopin®/day; \> 60 kg body weight: 150 mg Oligopin®/day

Treatment:

Dietary Supplement: Oligopin®

Placebo

Placebo Comparator group

Description:

Placebo treatment ( identical capsules containing maltodextrin and magnesium stearate )

Treatment:

Other: Placebo