NCT Number: NCT03368690
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.
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Notify Me7 year–64 year
All sexes
Interventional
Not applicable
Taipei Medical University - Shuang Ho Hospital, New Taipei City, Taiwan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
At the treatment period (0th to 4th week of the experiment), subjects with ADHD will receive 1~3 capsules of polyphenolic extract from pine bark (25mg or 50 mg Oligopin per capsule) according to their body weight and age. 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.
At the treatment period (0th to 4th week of the experiment), subjects with ADHD will receive 1~3 capsules of polyphenolic extract from pine bark (25mg or 50 mg Oligopin per capsule) according to their body weight and age. 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.
Time frame: at the start of the experiment and at the 4th, 7th and 10th week
It is used to evaluate the inattention, impulsivity and hyperactivity for children and adolescent with ADHD as rated by parents and teachers. When Inattention/Hyperactivity-impulsivity subscales approach P85, the participants are going to the next steps.
When subjects took Oligopin that scores decrease significantly than beseline on inattention.
Time frame: at the start of the experiment and at the 4th, 7th and 10th week
It is used to evaluate the inattention, impulsivity and hyperactivity for adult with ADHD as rated by participants. The scores of ASRS-V1.1 more than 17, that can be going to the next steps.
When subjects took Oligopin that scores decrease significantly than beseline on impulsivity and hyperactivity.
Time frame: at the start of the experiment and at the 4th, 7th and 10th week
It is used to evaluate the inattention, impulsivity and vigilance for subjects with ADHD. T-score > 60 approach clinical standard.
In the part of inattention, during supplementation of PE all sub-items were no difference when compared with baseline and sub-items of commissions were lower than placebo group (p<0.05). Hyperactivity results were the same with part of inattention.
Time frame: at the start of the experiment and at the 4th, 7th and 10th week
Use Wechsler memory test to evaluate performance progressing in concentration and impulse control for adults
Among the result of WMS, there were no significant difference in each period.
Time frame: at the start of the experiment and at the 4th, 7th and 10th week
Use Wisconsin card test to evaluate performance progressing in concentration, impulse control for adults
Among the results of WCST, there were no significantly difference between each group.
Time frame: at the start of the experiment and at the 4th, 10th week
Serum AST,ALT and bilirubin-total are in units per liter.
there were no difference in each group.
Time frame: at the start of the experiment and at the 4th, 10th week
Serum BUN,Creatine and urine acid are in milligram per deciliter
there were no difference in each group.
Time frame: at the start of the experiment and at the 4th, 10th week
Serum HDL-Cho, LDL-Cho, triglyceride and total cholesterol are in milligram per deciliter
there were no difference in each group.
Time frame: at the start of the experiment and at the 4th, 10th week
Serum WBC in 1000/uL , RBC in 1000000/uL, hemoglobin in gram per deciliter, hematocrit in percentage , MCV in femtoliter , MCH in picogram, MCHC in gram per deciliter, platelet in 1000/uL ; neutrophils, lymphocytes, monocytes, eosinophils and basophils are in percentage.
there were no difference in each group.
Time frame: at the start of the experiment and at the 4th, 10th week
Serum iron, ferritin and TIBC are in microgram per deciliter
there were no difference in each group.
Time frame: at the start of the experiment and at the 4th, 10th week
Thiobarbituric acid-reactive substance, glutathione/oxidized glutathione ratio ,and plasma 8-isoprostane.
During PE supplementation, plasma TBARS level was significantly lower than placebo group (p < 0.05), and there was no significant difference between baseline and PE group.
During PE supplementation, GSH / GSSG ratio in red blood cells was significantly higher than baseline and placebo group (p < 0.05), but there was no significantly difference between baseline and placebo group.
After 4 weeks of supplementation PE and Placebo, the results of plasma 8-isoprostane level were shown in Figure 7C. There was no significantly difference in each group.
Time frame: at the beginning, 4th, 7th and 10th of the experiment
To analyze nutrition status of participants.
the frequency of staple foods, vegetables, fruits and milk intake insufficient in one day.
Time frame: at 2nd , 4th, 6th and 10th week of study
To analyze nutrition status of participants.
The intake of carbohydrates and fat of three major nutrients was insufficient and protein was excessive.
In terms of vitamins, vitamin B1, vitamin B2, vitamin E consumed appropriately, vitamin B6, vitamin A consumed excessively, Vitamin C was insufficient.
In micronutrients, calcium and iron was insufficient, and sodium, zinc and magnesium consumed in moderation.
Taipei Medical University
Other
Effects of Polyphenolic Extract From Pine Bark on the Inattention and Hyperactivity in Patients With Attention Deficit Hyperactivity Disorder Based on the Antioxidative Status.
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