ADHDNCT03368690
Therapeutic Effects of Pine Bark Extracts in Attention Deficit Hyperactivity Disorder
A study testing Oligopin® in people with ADHD, run by Taipei Medical University at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 64 years
- Conditions the study is for
- ADHD
- What is being tested?
- Oligopin®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 2 sitesTaiwan
- Study dates
- 28 Oct 2017to 23 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
- 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.
Who cannot join
- Children or adolescent treated with ADHD drugs, antihypertensive drugs and dietary supplements
- Adults treated with antihypertensive drugs and dietary supplements
- Nervous system diseases (including brain or other central nervous system diseases, e.g. epilepsy)
- Autism spectrum disorder
- Intellectual disability
- Other mental disorders (e.g. Schizophrenia, Bipolar Disorder, Major depressive disorder, Anxiety Disorder, Personality disorders, Conduct disorder, Tourette Syndrome.)
- Hepatic, renal, gastrointestinal and cardiovascular disorders
- Biochemical abnormality
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Taipei Medical University - Shuang Ho Hospital
New Taipei City, 23561
Taiwan Adventist Hospital
Taipei, 10556
About this study
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.
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.
Read the 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.
- Conditions
- ADHD
- Being tested
- Oligopin®, Placebo
- Keywords
- pine barkextract, antioxidant, ADHD, catecholamine
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oligopin®Dietary supplement
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Oligopin® | Experimental | 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 Receives: Dietary Supplement: Oligopin® |
| Placebo | Placebo comparator | Placebo treatment ( identical capsules containing maltodextrin and magnesium stearate ) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV)
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.
Measured: at the start of the experiment and at the 4th, 7th and 10th week
Adult ADHD Self-Report Scale-V1.1 (ASRS-V1.1) or Individual Subjective Perception Job Stress Scale (ISPJSS)
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.
Measured: at the start of the experiment and at the 4th, 7th and 10th week
Conners' Continuous Performance Test (CPT-III)
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.
Measured: at the start of the experiment and at the 4th, 7th and 10th week
Wechsler Memory Scale , WMS-III
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.
Measured: at the start of the experiment and at the 4th, 7th and 10th week
Wisconsin Card Sorting Test, WCST
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.
Measured: at the start of the experiment and at the 4th, 7th and 10th week
Secondary outcomes (8)
Liver function
Serum AST,ALT and bilirubin-total are in units per liter.
there were no difference in each group.
Measured: at the start of the experiment and at the 4th, 10th week
Kidney function
Serum BUN,Creatine and urine acid are in milligram per deciliter
there were no difference in each group.
Measured: at the start of the experiment and at the 4th, 10th week
Lipid profile
Serum HDL-Cho, LDL-Cho, triglyceride and total cholesterol are in milligram per deciliter
there were no difference in each group.
Measured: at the start of the experiment and at the 4th, 10th week
Hematology
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.
Measured: at the start of the experiment and at the 4th, 10th week
Iron status
Serum iron, ferritin and TIBC are in microgram per deciliter
there were no difference in each group.
Measured: at the start of the experiment and at the 4th, 10th week
Antioxidative status
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.
Measured: at the start of the experiment and at the 4th, 10th week
Food frequency questionnaire
To analyze nutrition status of participants.
the frequency of staple foods, vegetables, fruits and milk intake insufficient in one day.
Measured: at the beginning, 4th, 7th and 10th of the experiment
Three-day dietary record.
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.
Measured: at 2nd , 4th, 6th and 10th week of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start28 Oct 2017
- Primary completion21 Jun 2019
- Study completion23 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368690
- Sponsor's protocol ID
- N201706026
- Status last verified
- Jun 2019
- First submitted
- 14 Aug 2017
- Last updated
- 18 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03368690
- Acronym / sponsor ID
- N201706026
- Conditions
- ADHD
- Keywords
- pine barkextract, antioxidant, ADHD, catecholamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 28 Oct 2017 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 23 Aug 2019 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oligopin® | Experimental | Dietary Supplement: Oligopin®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 |
| Placebo | Placebo comparator | Other: PlaceboPlacebo treatment ( identical capsules containing maltodextrin and magnesium stearate ) |
Who may qualify
- Ages
- 7 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
- 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.
Key exclusion criteria (8 listed)
- Children or adolescent treated with ADHD drugs, antihypertensive drugs and dietary supplements
- Adults treated with antihypertensive drugs and dietary supplements
- Nervous system diseases (including brain or other central nervous system diseases, e.g. epilepsy)
- Autism spectrum disorder
- Intellectual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oligopin®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. | Dietary supplement | Oligopin® |
| PlaceboAt 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. | Other | Placebo |
Primary outcome
Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV)
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.
Adult ADHD Self-Report Scale-V1.1 (ASRS-V1.1) or Individual Subjective Perception Job Stress Scale (ISPJSS)
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.
Conners' Continuous Performance Test (CPT-III)
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.
Wechsler Memory Scale , WMS-III
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.
Wisconsin Card Sorting Test, WCST
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.
8 secondary outcomes
Liver function
Time frame: at the start of the experiment and at the 4th, 10th week
Kidney function
Time frame: at the start of the experiment and at the 4th, 10th week
Lipid profile
Time frame: at the start of the experiment and at the 4th, 10th week
Hematology
Time frame: at the start of the experiment and at the 4th, 10th week
Iron status
Time frame: at the start of the experiment and at the 4th, 10th week
Antioxidative status
Time frame: at the start of the experiment and at the 4th, 10th week
Food frequency questionnaire
Time frame: at the beginning, 4th, 7th and 10th of the experiment
Three-day dietary record.
Time frame: at 2nd , 4th, 6th and 10th week of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oligopin® in people with ADHD, run by Taipei Medical University at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV) (time frame: at the start of the experiment and at the 4th, 7th and 10th week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019; AzTrials last refreshed its copy on 6 Nov 2026.