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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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ClinicalTrials.gov Identifier: NCT03368690
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : September 18, 2018
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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 : August 30, 2017
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : June 30, 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: Change baseline four weeks of the experiment. ]
    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.

  2. Adult ADHD Self-Report Scale-V1.1 (ASRS-V1.1) or Individual Subjective Perception Job Stress Scale (ISPJSS) [ Time Frame: Change baseline four weeks of the experiment. ]
    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.

  3. Conners' Continuous Performance Test (CPT-III) [ Time Frame: Change baseline four weeks of the experiment. ]
    It is used to evaluate the inattention, impulsivity and vigilance for subjects with ADHD. T-score > 60 approach clinical standard.


Secondary Outcome Measures :
  1. Liver function [ Time Frame: Change baseline four weeks of the experiment. ]
    Serum AST,ALT and bilirubin-total are in units per liter

  2. Kidney function [ Time Frame: Change baseline four weeks of the experiment. ]
    Serum BUN,Creatine and urine acid are in milligram per deciliter

  3. Lipid profile [ Time Frame: Change baseline four weeks of the experiment. ]
    Serum HDL-Cho, LDL-Cho, triglyceride and total cholesterol are in milligram per deciliter

  4. Hematology [ Time Frame: Change baseline four weeks of the experiment. ]
    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.

  5. Iron status [ Time Frame: Change baseline four weeks of the experiment. ]
    Serum iron, ferritin and TIBC are in microgram per deciliter

  6. Antioxidative status [ Time Frame: Change baseline four weeks of the experiment. ]
    Thiobarbituric acid-reactive substance and glutathione/oxidized glutathione ratio.

  7. Dietary history [ Time Frame: Change baseline four weeks of the experiment. ]
    To analyze nutrition status of participants.

  8. 24 hour recall method [ Time Frame: Change baseline four weeks of the experiment. ]
    To analyze nutrition status of participants.

  9. Food frequency questionnaire [ Time Frame: Change baseline four weeks of the experiment. ]
    To analyze nutrition status of participants.

  10. Three-day dietary record. [ Time Frame: Change baseline four weeks of the experiment. ]
    To analyze nutrition status of participants.



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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


Contacts
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Contact: Suh-Ching Yang +886-2-2736-1661 ext 6553 sokei@tmu.edu.tw

Locations
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Taiwan
Taipei Medical University - Shuang Ho Hospital Recruiting
New Taipei City, Taiwan, 23561
Contact: I-Cheng Lin    886-2-22490088 ext 79212    12023@s.tmu.edu.tw   
Taiwan Adventist Hospital Recruiting
Taipei City, Taiwan, 10556
Contact: Alex Su    886-2-27718151 ext 2692    alexhsu588@yahoo.com.tw   
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, 2018
Last Verified: September 2018
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:
Polyphenolic extract from pine bark, Antioxidant, Attention deficit/hyperactivity disorder.

Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms