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Therapeutic Effects of Pine Bark Extracts in Attention Deficit Hyperactivity Disorder

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ClinicalTrials.gov Identifier: NCT03368690
Recruitment Status : Completed
First Posted : December 11, 2017
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Taipei Medical University

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.

Condition or disease Intervention/treatment Phase
ADHD Dietary Supplement: Oligopin® Other: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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.
Actual Study Start Date : October 28, 2017
Actual Primary Completion Date : June 21, 2019
Actual Study Completion Date : August 23, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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

Dietary Supplement: 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.

Placebo Comparator: Placebo
Placebo treatment ( identical capsules containing maltodextrin and magnesium stearate )
Other: Placebo
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.




Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.


  5. 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.



Secondary Outcome Measures :
  1. Liver function [ 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.


  2. Kidney function [ 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.


  3. Lipid profile [ 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.


  4. Hematology [ 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.


  5. Iron status [ 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.


  6. Antioxidative status [ 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.


  7. Food frequency questionnaire [ 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.


  8. Three-day dietary record. [ 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.




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Ages Eligible for Study:   7 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03368690


Locations
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Taiwan
Taipei Medical University - Shuang Ho Hospital
New Taipei City, Taiwan, 23561
Taiwan Adventist Hospital
Taipei City, Taiwan, 10556
Sponsors and Collaborators
Taipei Medical University

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Responsible Party: Taipei Medical University
ClinicalTrials.gov Identifier: NCT03368690     History of Changes
Other Study ID Numbers: N201706026
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Medical University:
pine barkextract, antioxidant, ADHD, catecholamine
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pycnogenols
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Platelet Aggregation Inhibitors