Effect of Pycnogenol® on attention-deficit hyperactivity disorder (ADHD)

Study protocol for a randomised controlled trial

Annelies A.J. Verlaet, Berten Ceulemans, Helene Verhelst, Dirk Van West, Tess De Bruyne, Luc Pieters, Huub F.J. Savelkoul, Nina Hermans

Research output: Contribution to journalArticleAcademicpeer-review

5 Citations (Scopus)

Abstract

Background: Methylphenidate (MPH), the first choice medication for attention-deficit hyperactivity disorder (ADHD), is associated with serious adverse effects like arrhythmia. Evidence on the association of ADHD with immune and oxidant-antioxidant imbalances offers potential for antioxidant and/or immunomodulatory nutritional supplements as ADHD therapy. One small randomised trial in ADHD suggests, despite various limitations, therapeutic benefit from Pycnogenol®, a herbal, polyphenol-rich extract. Methods: This phase III trial is a 10-week, randomised, double-blind, placebo and active treatment controlled multicentre trial with three parallel treatment arms to compare the effect of Pycnogenol® to MPH and placebo on the behaviour of 144 paediatric ADHD and attention-deficit disorder (ADD) patients. Evaluations of behaviour (measured by the ADHD-Rating Scale (primary endpoint) and the Social-emotional Questionnaire (SEQ)), immunity (plasma cytokine and antibody levels, white blood cell counts and faecal microbial composition), oxidative stress (erythrocyte glutathione, plasma lipid-soluble vitamins and malondialdehyde and urinary 8-OHdG levels, as well as antioxidant enzyme activity and gene expression), serum zinc and neuropeptide Y level, urinary catecholamines and physical complaints (Physical Complaints Questionnaire) will be performed in week 10 and compared to baseline. Acceptability evaluations will be based on adherence, dropouts and reports of adverse events. Dietary habits will be taken into account. Discussion: This trial takes into account comorbid behavioural and physical symptoms, as well as a broad range of innovative immune and oxidative biomarkers, expected to provide fundamental knowledge on ADHD aetiology and therapy. Research on microbiota in ADHD is novel. Moreover, the active control arm is rather unseen in research on nutritional supplements, but of great importance, as patients and parents are often concerned with the side effects of MPH. Trial registration: Clinicaltrials.gov number: NCT02700685. Registered on 18 January 2016. EudraCT 2016-000215-32. Registered on 4 October 2016.

Original languageEnglish
Article number145
Number of pages9
JournalTrials
Volume18
DOIs
Publication statusPublished - 2017

Fingerprint

Attention Deficit Disorder with Hyperactivity
Randomized Controlled Trials
Methylphenidate
Antioxidants
Placebos
Therapeutics
pycnogenols
Behavioral Symptoms
Neuropeptide Y
Microbiota
Polyphenols
Feeding Behavior
Malondialdehyde
Leukocyte Count
Research
Oxidants
Vitamins
Multicenter Studies
Catecholamines
Glutathione

Keywords

  • ADD
  • ADHD
  • Antioxidant
  • Behaviour
  • Catecholamines
  • Immunity
  • Oxidative stress
  • Polyphenols
  • Pycnogenol®

Cite this

Verlaet, A. A. J., Ceulemans, B., Verhelst, H., Van West, D., De Bruyne, T., Pieters, L., ... Hermans, N. (2017). Effect of Pycnogenol® on attention-deficit hyperactivity disorder (ADHD): Study protocol for a randomised controlled trial. Trials, 18, [145]. https://doi.org/10.1186/s13063-017-1879-6
Verlaet, Annelies A.J. ; Ceulemans, Berten ; Verhelst, Helene ; Van West, Dirk ; De Bruyne, Tess ; Pieters, Luc ; Savelkoul, Huub F.J. ; Hermans, Nina. / Effect of Pycnogenol® on attention-deficit hyperactivity disorder (ADHD) : Study protocol for a randomised controlled trial. In: Trials. 2017 ; Vol. 18.
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Effect of Pycnogenol® on attention-deficit hyperactivity disorder (ADHD) : Study protocol for a randomised controlled trial. / Verlaet, Annelies A.J.; Ceulemans, Berten; Verhelst, Helene; Van West, Dirk; De Bruyne, Tess; Pieters, Luc; Savelkoul, Huub F.J.; Hermans, Nina.

In: Trials, Vol. 18, 145, 2017.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - Effect of Pycnogenol® on attention-deficit hyperactivity disorder (ADHD)

T2 - Study protocol for a randomised controlled trial

AU - Verlaet, Annelies A.J.

AU - Ceulemans, Berten

AU - Verhelst, Helene

AU - Van West, Dirk

AU - De Bruyne, Tess

AU - Pieters, Luc

AU - Savelkoul, Huub F.J.

AU - Hermans, Nina

PY - 2017

Y1 - 2017

N2 - Background: Methylphenidate (MPH), the first choice medication for attention-deficit hyperactivity disorder (ADHD), is associated with serious adverse effects like arrhythmia. Evidence on the association of ADHD with immune and oxidant-antioxidant imbalances offers potential for antioxidant and/or immunomodulatory nutritional supplements as ADHD therapy. One small randomised trial in ADHD suggests, despite various limitations, therapeutic benefit from Pycnogenol®, a herbal, polyphenol-rich extract. Methods: This phase III trial is a 10-week, randomised, double-blind, placebo and active treatment controlled multicentre trial with three parallel treatment arms to compare the effect of Pycnogenol® to MPH and placebo on the behaviour of 144 paediatric ADHD and attention-deficit disorder (ADD) patients. Evaluations of behaviour (measured by the ADHD-Rating Scale (primary endpoint) and the Social-emotional Questionnaire (SEQ)), immunity (plasma cytokine and antibody levels, white blood cell counts and faecal microbial composition), oxidative stress (erythrocyte glutathione, plasma lipid-soluble vitamins and malondialdehyde and urinary 8-OHdG levels, as well as antioxidant enzyme activity and gene expression), serum zinc and neuropeptide Y level, urinary catecholamines and physical complaints (Physical Complaints Questionnaire) will be performed in week 10 and compared to baseline. Acceptability evaluations will be based on adherence, dropouts and reports of adverse events. Dietary habits will be taken into account. Discussion: This trial takes into account comorbid behavioural and physical symptoms, as well as a broad range of innovative immune and oxidative biomarkers, expected to provide fundamental knowledge on ADHD aetiology and therapy. Research on microbiota in ADHD is novel. Moreover, the active control arm is rather unseen in research on nutritional supplements, but of great importance, as patients and parents are often concerned with the side effects of MPH. Trial registration: Clinicaltrials.gov number: NCT02700685. Registered on 18 January 2016. EudraCT 2016-000215-32. Registered on 4 October 2016.

AB - Background: Methylphenidate (MPH), the first choice medication for attention-deficit hyperactivity disorder (ADHD), is associated with serious adverse effects like arrhythmia. Evidence on the association of ADHD with immune and oxidant-antioxidant imbalances offers potential for antioxidant and/or immunomodulatory nutritional supplements as ADHD therapy. One small randomised trial in ADHD suggests, despite various limitations, therapeutic benefit from Pycnogenol®, a herbal, polyphenol-rich extract. Methods: This phase III trial is a 10-week, randomised, double-blind, placebo and active treatment controlled multicentre trial with three parallel treatment arms to compare the effect of Pycnogenol® to MPH and placebo on the behaviour of 144 paediatric ADHD and attention-deficit disorder (ADD) patients. Evaluations of behaviour (measured by the ADHD-Rating Scale (primary endpoint) and the Social-emotional Questionnaire (SEQ)), immunity (plasma cytokine and antibody levels, white blood cell counts and faecal microbial composition), oxidative stress (erythrocyte glutathione, plasma lipid-soluble vitamins and malondialdehyde and urinary 8-OHdG levels, as well as antioxidant enzyme activity and gene expression), serum zinc and neuropeptide Y level, urinary catecholamines and physical complaints (Physical Complaints Questionnaire) will be performed in week 10 and compared to baseline. Acceptability evaluations will be based on adherence, dropouts and reports of adverse events. Dietary habits will be taken into account. Discussion: This trial takes into account comorbid behavioural and physical symptoms, as well as a broad range of innovative immune and oxidative biomarkers, expected to provide fundamental knowledge on ADHD aetiology and therapy. Research on microbiota in ADHD is novel. Moreover, the active control arm is rather unseen in research on nutritional supplements, but of great importance, as patients and parents are often concerned with the side effects of MPH. Trial registration: Clinicaltrials.gov number: NCT02700685. Registered on 18 January 2016. EudraCT 2016-000215-32. Registered on 4 October 2016.

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KW - ADHD

KW - Antioxidant

KW - Behaviour

KW - Catecholamines

KW - Immunity

KW - Oxidative stress

KW - Polyphenols

KW - Pycnogenol®

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DO - 10.1186/s13063-017-1879-6

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VL - 18

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 145

ER -