A randomized controlled trial investigating the effects of PCSO-524?, a patented oil extract of the New Zealand green lipped mussel (Perna canaliculus), on the behaviour, mood, cognition and neurophysiology of children and a
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- 作者：James D Kean (3)
David Camfield (3)
Jerome Sarris (3) (3)
Marni Kras (3)
Richard Silberstein (3)
Andrew Scholey (3)
Con Stough (3) - 关键词：Lyprinol ; Omega XL ; ADHD ; Hyperactivity ; Impulsivity ; Omega 3?s ; Marine oil extract ; RCT
- 刊名：Nutrition Journal
- 出版年：2013
- 出版时间：December 2013
- 年：2013
- 卷：12
- 期：1
- 全文大小：717 KB
- 参考文献：1. Biederman J: Attention-deficit/hyperactivity disorder: a selective overview. / Biol Psychiatry 2005,57(11):1215-220. CrossRef
2. American Psychiatric Association: / Diagnostic and statistical manual of mental disorders DSM-IV-TR. 4th edition. Washington: American Psychiatric Publishing; 2000.
3. Wolraich ML, Wibbelsman CJ, Brown TE, / et al.: Attention-deficit/hyperactivity disorder among adolescents: a review of the diagnosis, treatment, and clinical implications. / Pediatrics 2005,115(6):1734-746. CrossRef
4. Curtis LT, Patel K: Nutritional and environmental approaches to preventing and treating autism and attention deficit hyperactivity disorder (ADHD): a review. / J Alter Complem Med 2008,14(1):79-5. CrossRef
5. Millichap JG: Etiologic classification of attention-deficit/hyperactivity disorder. / Pediatrics 2008,121(2):358-65. CrossRef
6. Richardson AJ: The importance of omega-3 fatty acids for behaviour, cognition and mood. / Scandinavian J Nutri Narings skning 2003,47(2):92-8. CrossRef
7. Di Michele F, Prichep L, John ER, Chabot RJ: The neurophysiology of attention-deficit/hyperactivity disorder. / Int J Psychophysiol 2005,58(1):81-3. CrossRef
8. Chabot RJ, Di Michele F, Prichep L, John ER: The clinical role of computerized EEG in the evaluation and treatment of learning and attention disorders in children and adolescents. / J Neuropsychiatry Clin Neurosci 2001,13(2):171-86. CrossRef
9. Dvorakova M, Jezova D, Blazicek P, / et al.: Urinary catecholamines in children with attention deficit hyperactivity disorder (ADHD): modulation by a polyphenolic extract from pine bark (pycnogenol). / Nutr Neurosci Jun-Aug 2007,10(3-):151-57. CrossRef
10. Chabot RJ, Serfontein G: Quantitative electroencephalographic profiles of children with attention deficit disorder. / Biol Psychiatry 1996,40(10):951-63. CrossRef
11. Clarke AR, Barry RJ, McCarthy R, Selikowitz M: Electroencephalogram differences in two subtypes of attention-deficit/hyperactivity disorder. / Psychophysiology 2001,38(2):212-21. CrossRef
12. Lazzaro I, Gordon E, Whitmont S, / et al.: Quantified EEG activity in adolescent attention deficit hyperactivity disorder. / Clin EEG Electroencephalogr 1998,29(1):37-2.
13. Richardson AJ: Clinical trials of fatty acid treatment in ADHD, dyslexia, dyspraxia and the autistic spectrum. / Prostaglandins Leukotri Essential Fatty Acids 2004,70(4):383-90. CrossRef
14. Ward PE: Potential diagnostic aids for abnormal fatty acid metabolism in a range of neurodevelopmental disorders. / Prostaglandins Leukot Essent Fatty Acids 2000,63(1-):65-8. CrossRef
15. Sinn N, Bryan J: Effect of supplementation with polyunsaturated fatty acids and micronutrients on learning and behavior problems associated with child ADHD. / J Dev Behav Pediatr 2007,28(2):82-1. CrossRef
16. Voigt RG, Llorente AM, Jensen CL, Fraley JK, Berretta MC, Heird WC: A randomized, double-blind, placebo-controlled trial of docosahexaenoic acid supplementation in children with attention-deficit/hyperactivity disorder. / J Pediatr 2001,139(2):189-96. CrossRef
17. Sarris J, Kean J, Schweitzer I, Lake J: Complementary medicines (herbal and nutritional products) in the treatment of attention deficit hyperactivity disorder (ADHD): a systematic review of the evidence. / Complem Therap Med 2011,19(4):216-27. CrossRef
18. Cimera R: / Making ADHD a gift: teaching Superman how to fly. Vol 16 edition. Lanham: Scarecrow Press, Inc; 2002.
19. El-Sayed E, Larsson JO, Persson HE, Santosh PJ, Rydelius PA: “Maturational lag-hypothesis of attention deficit hyperactivity disorder: an update. / Acta Paediatrica Int J Paediat 2003,92(7):776-84. CrossRef
20. Biederman J, Faraone SV: Attention-deficit hyperactivity disorder. / Lancet 2005,366(9481):237-48. CrossRef
21. Schmeichel BE, Zemlan FP, Berridge CW: A selective dopamine reuptake inhibitor improves prefrontal cortex-dependent cognitive function: potential relevance to attention deficit hyperactivity disorder. / Neuropharmacology 2013,64(0):321-28. CrossRef
22. Wallis D, Russell HF, Muenke M: Review: genetics of attention deficit/hyperactivity disorder. / J Pediatr Psychol 2008,33(10):1085-099. CrossRef
23. Swanson JM, Kinsbourne M, Nigg J, / et al.: Etiologic subtypes of attention-deficit/hyperactivity disorder: brain imaging, molecular genetic and environmental factors and the dopamine hypothesis. / Neuropsychol Rev 2007,17(1):39-9. CrossRef
24. McCann D, Barrett A, Cooper A, / et al.: Food additives and hyperactive behaviour in 3-year-old and 8/9-year-old children in the community: a randomised, double-blinded, placebo-controlled trial. / Lancet 2007,370(9598):1560-567. CrossRef
25. Spencer RC, Klein RM, Berridge CW: Psychostimulants act within the prefrontal cortex to improve cognitive function. / Biol Psychiatry 2012,72(3):221-27. CrossRef
26. Simonoff E, Taylor E, Baird G, / et al.: Randomized controlled double-blind trial of optimal dose methylphenidate in children and adolescents with severe attention deficit hyperactivity disorder and intellectual disability. / J Child Psychol Psychiatry 2013,54(5):527-35. CrossRef
27. Schachter HM, Pham B, King J, Langford S, Moher D: How efficacious and safe is short-acting methylphenidate for the treatment of attention-deficit disorder in children and adolescents? / A meta-analy Canadian Med Assoc J 2001,165(11):1475-488.
28. Sonuga-Barke EJS, Coghill D, Wigal T, Debacker M, Swanson J: Adverse reactions to methylphenidate treatment for attention-deficit/hyperactivity disorder: structure and associations with clinical characteristics and symptom control. / J Child Adol Psychopharmacol 2009,19(6):683-90. CrossRef
29. Kemper KJ, Vohra S, / et al.: The use of complementary and alternative medicine in pediatrics. / Pediatrics 2008,122(6):1374-386. CrossRef
30. Rucklidge JJ, Johnstone J, Kaplan BJ: Nutrient supplementation approaches in the treatment of ADHD. / Expert Rev Neurother 2009,9(4):461-76. CrossRef
31. Karpouzis F, Bonello R, Pollard H: Chiropractic care for paediatric and adolescent attention-deficit/hyperactivity disorder: a systematic review. 2010, 1746-340.
32. Dyerberg J: Linolenate-derived polyunsaturated fatty acids and prevention of atherosclerosis. / Nutr Rev 1986,44(4):125-34. CrossRef
33. Burgess JR, Stevens L, Zhang W, Peck L: Long-chain polyunsaturated fatty acids in children with attention- deficit hyperactivity disorder. / Am J Clin Nutr 2000,71(1 SUPPL):327S-330S.
34. Kidd PM: Omega-3 DHA and EPA for cognition, behavior, and mood: clinical findings and structural-functional synergies with cell membrane phospholipids. / Altern Med Rev 2007,12(3):207-27.
35. Freeman MP, Hibbeln JR, Wisner KL, / et al.: Omega-3 fatty acids: evidence basis for treatment and future research in psychiatry. / J Clin Psychiatry 2006,67(12):1954-967. CrossRef
36. Fontani G, Corradesschi F, Felici A: European journal of clinical investigation. / Eur J Clin Investig 2005,35(11):691-99. 2005 CrossRef
37. Hickman RW: Perna canaliculus (Gmelin) in New Zealand. In / Estuarine and marine bivalve mollusk culture. Edited by: Menzel W. Boca Raton, FL: CRC Press; 1991:325-34.
38. Croft J: / Relief from arthritis: a safe and effective treatment from the ocean. Wellingbororough, Northampton, UK: Thorsons Publishers Ltd; 1980.
39. Sinclair AJ, Murphy KJ, Li D: Marine lipids: overview “news insights and lipid composition of Lyprinol- / Allerg Immunol (Paris). 2000,32(7):261-71.
40. Emelyanov A, Fedoseev G, Krasnoschekova O, Abulimity A, Trendeleva T, Barnes PJ: Treatment of asthma with lipid extract of New Zealand green-lipped mussel: a randomised clinical trial. / Eur Respir J 2002,20(3):596-00. CrossRef
41. Whitehouse MW, Macrides TA, Kalafatis N, Betts WH, Haynes DR, Broadbent J: Anti-inflammatory activity of a lipid fraction (lyprinol) from the NZ green-lipped mussel. / Inflammopharmacology 1997,5(3):237-46. CrossRef
42. Cobb CS, Ernst E: Systematic review of a marine nutriceutical supplement in clinical trials for arthritis: the effectiveness of the New Zealand green-lipped mussel perna canaliculus. / Clin Rheumatol 2006,25(3):275-84. CrossRef
43. Walker-Bone K: ‘Natural remedies-in the treatment of osteoarthritis. / Drugs Aging 2003,20(7):517-26. CrossRef
44. Morelli V, Naquin C, Weaver V: Alternative therapies for traditional disease states: osteoarthritis. / Am Fam Physician 2003,67(2):339-44.
45. Kosuge T, Tsuji K, Ishida H, Yamaguchi T: Isolation of an antihistaminic substance from green-lipped mussel (Perna canaliculus). / Chemical Pharmacology Bulletin 1986, 34:4825-828. CrossRef
46. Whitehouse MW, Macrides TA, Kalafatis N: Anti-inflammatory activity of a lipid fraction (Lyprinol) from the NZ Green-lipped mussel. / Infammopharmacol 1997, 5:237-46. 1997 CrossRef
47. Macrides T, Kalafatis N: Lipid extract having anti-inflammatory activity. 2002.
48. Lau CS, Chiu PKY, Chu EMY, / et al.: Treatment of knee osteoarthritis with Lyprinol?, lipid extract of the green-lipped mussel - A double-blind placebo-controlled study. / Prog Nutr 2004,6(1):17-1.
49. Brien S, Prescott P, Coghlan B: Systematic review of the nutritional supplement perna canaliculus (green-lipped mussel) in the treatment of osteoarthritis. / Quarter J Med 2008, 101:167-79. 2008 CrossRef
50. Whitehouse MW, Roberts MS, Brooks PM: Over the counter (OTC) oral remedies for arthritis and rheumatism: how effective are they? / Inflammopharmacology 1999,7(2):89-05. CrossRef
51. Conners CK: A teacher rating scale for use in drug studies with children. / Am J Psychiatry 1969,126(6):884-88.
52. Conners CK: Symptom patterns in hyperkinetic, neurotic, and normal children. / Child Development 1970,41(3):667-82. CrossRef
53. Loo SK, Barkley RA: Clinical utility of EEG in attention deficit hyperactivity disorder. / Appl Neuropsychol 2005,12(2):64-6. CrossRef
54. Llorente AM, Voigt R, Jensen CL, Fraley JK, Heird WC, Rennie KM: The test of variables of attention (TOVA): internal consistency (Q 1 vs. Q2 and Q3 vs. Q4) in children with attention deficit/hyperactivity disorder (ADHD). / Child Neuropsychol 2008,14(4):314-22. CrossRef
55. Terry PC, Lane AM, Lane HJ, Keohane L: Development and validation of a mood measure for adolescents. / J Sports Sci 1999,17(11):861-72. 1999/01/01 CrossRef
56. Conners CK, Sitarenios G, Parker JDA, Epstein JN: The revised Conners-parent rating scale (CPRS-R): factor structure, reliability, and criterion validity. / J Abnor Child Psychol 1998,26(4):257-68. CrossRef
57. Kennedy DO, Dodd FL, Robertson BC, / et al.: Monoterpenoid extract of sage (Salvia lavandulaefolia) with cholinesterase inhibiting properties improves cognitive performance and mood in healthy adults. / J Psychopharmacol 2011,25(8):1088-100. CrossRef
58. Kennedy DO, Haskell CF: Vitamins and cognition: what is the evidence? / Drugs 2011,71(15):1957-971. CrossRef
59. Kennedy DO, Haskell CF, Robertson B: Improved cognitive performance and mental fatigue following a multi-vitamin and mineral supplement with added guarana (Paullinia cupana). / Appetite 2008, 50:506-13. 2008 CrossRef
60. Reay JL, Kennedy DO, Scholey AB: The glycaemic effects of single doses of Panax ginseng in young healthy volunteers. / Br J Nutr 2006, 96:639-42. 2006
61. Reay JL, Scholey AB, Kennedy DO: Panax ginseng (G115) improves aspects of working memory performance and subjective ratings of calmness in healthy young adults. / Hum Psychopharmacol 2010,25(6):462-71. CrossRef
62. Scholey AB, Harper S, Kennedy DO: Cognitive demand and blood gllucose. / Physiol Behav 2001,73(4):585-92. 2001 CrossRef
63. Scholey AB, Kennedy DO: Cognitive and physiological effects of an “energy drink- an evaluation of the whole drink and of glucose, caffeine and herbal flavouring fractions. / Psychopharmacology 2004,176(3-):320-30. 2004 CrossRef
64. McNair DM, Lorr M, Droppleman LF: / Revised manual for the profile of mood states. San Diego, CA: Services EaIT; 1992.
65. Terry PC, Lane AM, Fogarty GJ: Construct validity of the profile of mood states - adolescents for use with adults. / Psychol Sport Exer 2003,4(2):125-39. CrossRef
66. Barry RJ, Clarke AR, Johnstone SJ, Oades RD: Electrophysiology in attention-deficit/hyperactivity disorder. / Int J Psychophysiol 2005,58(1):1-. CrossRef
67. Barry RJ, Clarke AR, McCarthy R, Selikowitz M, Brown CR: Event-related potentials in children with attentiondeficit/hyperactivity disorder and excess beta activity in the EEG. / Acta Neuropsychologica 2009,7(4):249-63.
68. Clarke AR, Barry RJ, Dupuy FE, / et al.: Behavioural differences between EEG-defined subgroups of children with attention-deficit/hyperactivity disorder. / Clin Neurophysiol 2011,122(7):1333-341. CrossRef
69. Clarke AR, Barry RJ, Dupuy FE, McCarthy R, Selikowitz M, Heaven PCL: Childhood EEG as a predictor of adult attention-deficit/hyperactivity disorder. / Clin Neurophysiol 2011,122(1):73-0. CrossRef
70. Clarke AR, Barry RJ, McCarthy R, Selikowitz M: Age and sex effects in the EEG: Differences in two subtypes of attention-deficit/hyperactivity disorder. / Clin Neurophysiol 2001,112(5):815-26. CrossRef
71. Clarke AR, Barry RJ, McCarthy R, Selikowitz M, Clarke DC, Croft RJ: EEG activity in girls with attention-deficit/hyperactivity disorder. / Clin Neurophysiol 2003,114(2):319-28. CrossRef
72. Regan D: / Human brain electrophysiology: evoked potentials and evoked magnetic fields in science and medicine. East Norwalk, Connecticut 06855: Appleton & Lange Publishing Company; 1989.
73. Silberstein RB, Ciorciari J, Pipingas A: Steady-state visually evoked potential topography during the wisconsin card sorting test. / Electroencephalogr Clin Neurophysiol 1995,96(1):24-5. CrossRef - 作者单位：James D Kean (3)
David Camfield (3)
Jerome Sarris (3) (3)
Marni Kras (3)
Richard Silberstein (3)
Andrew Scholey (3)
Con Stough (3)
3. Department of Psychiatry, University of Melbourne, Melbourne, Australia - ISSN：1475-2891
文摘
Background The prevalence rate of attention-deficit/hyperactivity disorder (ADHD) within Western cultures is between 5% and 12%, and is the most common psychiatric illness among school-aged children, with an estimated 50% of these children retaining ADHD symptoms for the rest of their lives. Children with ADHD have lower blood levels of long-chain Poly Unsaturated Fatty Acids (LC PUFAs) compared with children without ADHD, and following PUFA supplementation, have shown improvements in ADHD-related symptoms. One highly promising marine based LC PUFA preparation is the Omega-3-rich Lyprinol/Omega XL which is a natural formulation containing standardised lipid extract of the New Zealand green lipped mussel (Perna canaliculus) known as PCSO-524? which contains a unique combination of free fatty acids, sterol esters, polar lipids and carotenoids. It is this unique combination of marine lipids that may assist in correcting the decreased levels of LC PUFA levels in children with symptoms of ADHD. The compound is a mixture belonging to a lipid group called sterol esters (SE). The fatty acids in the SE fraction are mainly myristic acid, palmitic acid, palmitoleic acid, stearic acid, oleic acid, linoleic acid, eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA). Lyprinol/Omega XL has previously been shown to contain a potent group of Omega-3 lipids that block the 5 - lipoxygenase metabolic pathway responsible for inflammation in the body. Methods A randomized double blind placebo controlled trial will be utilized to assess the effects of 14?weeks administration of Lyprinol/Omega XL versus placebo in 150 children aged 6 to 14?years with high levels of hyperactivity and inattention. Additionally, a range of cognitive, mood and central electrophysiological measures will be undertaken during the 14?week supplementation trial. The primary outcome measure, the Conners-Parent Rating Scales will be completed initially at baseline, then in weeks 4, 8, 10, 14 and then again at 4?weeks post-administration (week 18). The results will contribute to our understanding of the efficacy of marine based Omega-3?s with high anti-inflammatory actions on inattention and hyperactivity in children aged 6 to 14?years.