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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 adolescents (aged 6-14 years) experiencing clinical and sub-clinical levels of hyperactivity and inattention: study protocol ACTRN12610000978066.
Nutr J. 2013 Jul 16; 12:100.NJ

Abstract

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.

Authors

No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23866813

Citation

Kean, James D., et al. "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 Adolescents (aged 6-14 Years) Experiencing Clinical and Sub-clinical Levels of Hyperactivity and Inattention: Study Protocol ACTRN12610000978066." Nutrition Journal, vol. 12, 2013, p. 100.
Kean JD, Camfield D, Sarris J, et al. 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 adolescents (aged 6-14 years) experiencing clinical and sub-clinical levels of hyperactivity and inattention: study protocol ACTRN12610000978066. Nutr J. 2013;12:100.
Kean, J. D., Camfield, D., Sarris, J., Kras, M., Silberstein, R., Scholey, A., & Stough, C. (2013). 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 adolescents (aged 6-14 years) experiencing clinical and sub-clinical levels of hyperactivity and inattention: study protocol ACTRN12610000978066. Nutrition Journal, 12, 100. https://doi.org/10.1186/1475-2891-12-100
Kean JD, et al. 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 Adolescents (aged 6-14 Years) Experiencing Clinical and Sub-clinical Levels of Hyperactivity and Inattention: Study Protocol ACTRN12610000978066. Nutr J. 2013 Jul 16;12:100. PubMed PMID: 23866813.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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 adolescents (aged 6-14 years) experiencing clinical and sub-clinical levels of hyperactivity and inattention: study protocol ACTRN12610000978066. AU - Kean,James D, AU - Camfield,David, AU - Sarris,Jerome, AU - Kras,Marni, AU - Silberstein,Richard, AU - Scholey,Andrew, AU - Stough,Con, Y1 - 2013/07/16/ PY - 2012/08/22/received PY - 2013/06/10/accepted PY - 2013/7/23/entrez PY - 2013/7/23/pubmed PY - 2015/3/31/medline SP - 100 EP - 100 JF - Nutrition journal JO - Nutr J VL - 12 N2 - 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. SN - 1475-2891 UR - https://www.unboundmedicine.com/medline/citation/23866813/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_adolescents__aged_6_14_years__experiencing_clinical_and_sub_clinical_levels_of_hyperactivity_and_inattention:_study_protocol_ACTRN12610000978066_ L2 - https://nutritionj.biomedcentral.com/articles/10.1186/1475-2891-12-100 DB - PRIME DP - Unbound Medicine ER -