Enzymotec's Sharp●PS™ PLATINUM PS-DHA/EPA conjugation
A promising formulation for ADHD looks to be Enzymotec's Sharp-PS™ PLATINUM PS-DHA/EPA conjugation which isn't yet publicly available. For what it's worth below are some details of an 'internal' [:o] study Enzymotec did on a product called Sharp●PS™ PLATINUM on schoolchildren with ADHD. This product is similar to their Sharp●PS™ GOLD except the PLATINUM version is a unique PS-DHA/EPA conjugation whereas the GOLD version is simply a PS-DHA conjugation. Now the GOLD formulation is available now in Country Life's Sharp Thought™ product as well as being in LEF's Cognitex with NeuroProtection Complex. It may be interesting to try the PLATINUM version (if anyone knows of a source?) though it may not give better results for ADHD than simply taking the same amounts of Fish Oil and Soy-derived Phosphatidyl Serine separately...
http://www.enzymotec.com/Page.aspEnzymotec to expose successful ADHD trial findings
[05,2007] Enzymotec' study on the effect of Sharp●PS™ PLATINUM on ADHD schoolchildren was presented at the 2007 Annual Meeting of the Pediatric Academic Societies (PAS), in Toronto. The study, conducted by Prof. Nachum Vaisman from the Sourasky Tel Aviv Medical Center, Tel-Aviv, Israel, involved over sixty children, divided in 3 groups .
"Providing Sharp●PS™ PLATINUM to these children had a pronounced impact on their Test of variables of Attention (TOVA) scores, inasmuch as 60% of them presented asymptomatic total TOVA score at the end of the intervention" says Dr. Dori Pelled, Enzymotec's CTO.
"We find it very reassuring that the alleviated TOVA results, were highly correlated with the incorporation of this product into the blood components. It seems that conjugation of Omega-3s to phospholipids have a significant beneficial effect on cognitive performance." concludes Dr. Pelled.
Sharp●PS™ PLATINUM is a unique PS-DHA/EPA conjugation, based on Enzymotec's unique line of cognitive products, including : Sharp●PS™ and Sharp●PS™ GOLD , which are already being marketed in the US and elsewhere. Earlier this year , the company has announced of a second, large clinical trial, which will be conducted in Israel and will further evaluate the product efficacy on the same product.
Enzymotec (www.enzymotec.com) is an Israeli biotech company, that seeks to provide branded nutrition companies with a better value proposition in 3 main health areas: CVD management, improving cognitive performance and balanced nutrition for babies.
We do that by taking ingredients, which have already gained market and scientific acceptance, such as: DHA, PS or plant-sterols and enhance their efficacy by mode of conjugation or modification. We also increase their value proposition by investing significant resources in clinical trials, regulatory affairs and patent protection while ensuring highest quality standards.
http://www.nutrition...ok.com/news.phpOmega-3 Enriched Phospholopids Show Promise For Pediatric ADHD Patients
ISRAEL – Pediatric ADHD patients may benefit from omega-3 LC-PUFA conjugated to phospholipids (PL-Omega3) according to a study presented during the 2007 Annual Meeting of the Pediatric Academic Societies (PAS), in Toronto.
The study, conducted by Prof. Nachum Vaisman from the Sourasky Tel Aviv Medical Center, Tel-Aviv, Israel, involved over sixty children, divided into three groups and randomized in a three month, double blind, placebo-controlled study. One group received PL-Omega3 (250 mg/d EPA+DHA and 300 mg/d PS), another received fish oil (250 mg/d EPA+DHA), while the control group received canola. Sustained visual attention and discrimination were objectively measured using the Test of Variables of Attention (TOVA). Omega-3 LC-PUFA incorporation into blood compartments also was analyzed.
The study reported that the PL-Omega3 and fish oil treatment groups showed marked increase in plasma phospholipids omega-3:omega-6 and in EPA:arachidonic acid (AA) ratios.
The TOVA average ADHD index z score improved by 3.35 SD and 1.72 SD for the PL-Omega3 and FO groups, respectively, compared with a decline of -0.42 SD for control patients (P<0.001).
All TOVA indexes under investigation were significantly (P<0.05) improved for PL-Omega3 group (0.75 SD 1.01 SD). Accordingly, in PL-Omega3 (11/18) but not in FO (7/21) a significant (P<0.05) ratio of subjects demonstrated asymptomatic ADHD index score, compared with control (3/21). Interestingly, the increase in EPA:AA ratios was shown to correlate with ADHD index score alterations only for PL-Omega3 group. No Adverse effects were recorded.
"Providing Sharp-PS™ PLATINUM to these children had a pronounced impact on their Test of variables of Attention (TOVA) scores, inasmuch as 60% of them presented asymptomatic total TOVA score at the end of the intervention" said Dr. Dori Pelled, Enzymotec's CTO.
"We find it very reassuring that the alleviated TOVA results, were highly correlated with the incorporation of this product into the blood components. It seems that conjugation of Omega-3s to phospholipids have a significant beneficial effect on cognitive performance." concludes Dr. Pelled.
Sharp-PS™ PLATINUM is PS-DHA/EPA conjugation, based on Enzymotec's line of cognitive products, including: Sharp-PS™ and Sharp-PS™ GOLD, which are already being marketed in the US and elsewhere.
Earlier this year, the company announced a second, large clinical trial, which will be conducted in Israel and will further evaluate the product efficacy on the same product.
For more information, visit www.enzymotec.com
published date: 05-15-2007
The above study sponsored by Enzymotec is in Pubmed now (see abstract below) and the full text can be viewed at
http://www.nutrition...ns/ajcnMay4.pdf.
1: Am J Clin Nutr. 2008 May;87(5):1170-80.
Correlation between changes in blood fatty acid composition and visual sustained attention performance in children with inattention: effect of dietary n-3 fatty acids containing phospholipids.
Vaisman N, Kaysar N, Zaruk-Adasha Y, Pelled D, Brichon G, Zwingelstein G, Bodennec J.
Clinical Nutrition Unit, Tel Aviv Sourasky Medical Center, Tel-Aviv, Israel. vaisman@tasmc.health.gov.il
BACKGROUND: Increasing evidence supports n-3 fatty acid (FA) supplementation for patients with psychiatric disorders, such as attention deficit hyperactivity disorder. However, the exact metabolic fate of dietary eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on different glyceride carriers remains unclear. OBJECTIVE: We investigated whether conjugation of EPA and DHA to phospholipid (PL-n-3) or to triacylglycerol (fish oil; FO) affects their incorporation in blood compartments and influences executive functioning. DESIGN: Children aged 8-13 y with impaired visual sustained attention performance received placebo, 250 mg/d EPA + DHA esterified to PL-n-3 (300 mg/d phosphatidylserine), or FO for 3 mo in a randomized double-blind manner. Main outcome measures included plasma and erythrocyte FA profile and continuous performance test results (Test of Variables of Attention; TOVA). RESULTS: Sixty of the 83 children enrolled completed the interventions (n = 18-21 per group). There was an enrichment of EPA (1.5-2.2-fold), docosapentaenoic acid (DPA; 1.2-fold), and DHA (1.3-fold) in the PL fraction in the plasma of FO- and PL-n-3-fed children. In erythrocytes, only PL-n-3 resulted in a significant reduction (approximately 30%) of very-long-chain saturated FAs (C20-24) and in an increase (1.2- and 2.2-fold, respectively) in linoleic acid and DPA. Total TOVA scores increased in the PL-n-3 (mean +/- SD: 3.35 +/- 1.86) and FO (1.72 +/- 1.67) groups but not in the placebo group (-0.42 +/- 2.51) (PL-n-3 > FO > placebo; P < 0.001). A significant correlation between the alterations in FAs and increased TOVA scores mainly occurred in the PL-n-3 group. CONCLUSION: Consumption of EPA+DHA esterified to different carriers had different effects on the incorporation of these FAs in blood fractions and on the visual sustained attention performance in children. This trial was registered at clinicaltrials.gov as NCT00382616.
PMID: 18469236 [PubMed - in process]
I don't have access to the full text of this study but I do know from cutting and pasting on searches it includes the following passage:
"...In the erythrocyte PLs, an increase ( 230%) in nervonic acid (24:1n–9) concentrations was detected in response to PL-n –3 administration compared with the placebo (P = 0.029) but not the FO (P 0.389) treatment..."
Nervonic Acid was found to be significantly lower in children with ADHD in the following study...
1: J Nutr Biochem. 2004 Aug;15(8):467-72. Links
Dietary patterns and blood fatty acid composition in children with attention-deficit hyperactivity disorder in Taiwan.Chen JR, Hsu SF, Hsu CD, Hwang LH, Yang SC.
Department of Nutrition and Health Sciences, Taipei Medical University, Taiwan.
Nutritional factors may be relative to attention-deficit hyperactive disorder (ADHD), although the pathogenic mechanism is still unknown. Based on the work of others, we hypothesized that children with ADHD have altered dietary patterns and fatty acid metabolism. Therefore, the aim of this study was to evaluate dietary patterns and the blood fatty acid composition in children with ADHD in the Taipei area of Taiwan. The present study found that 58 subjects with ADHD (average age 8.5 years) had significantly higher intakes of iron and vitamin C compared to those of 52 control subjects (average age 7.9 years) (P < 0.05). The blood total protein content in subjects with ADHD was significantly lower than that in control subjects (P < 0.05). On the other hand, children with ADHD had significantly higher blood iron levels compared to the control children (P < 0.05). Additionally, plasma gamma-linolenic acid (18:3 n-6) in children with ADHD was higher than that in control children (P < 0.05). Concerning the composition of other fatty acids in the phospholipid isolated from red blood cell (RBC) membranes, oleic acid (18:1n-9) was significantly higher, whereas nervonic acid (24:1n-9), linoleic acid (18:2n-6), arachidonic acid (20:4n-6), and docosahexaenoic acid (22:6n-3) were significantly lower in subjects with ADHD (P < 0.05). Our results suggest that there were no differences in dietary patterns of these children with ADHD except for the intake of iron and vitamin C; however, the fatty acid composition of phospholipid from RBC membranes in the ADHD children differed from that of the normal children.
PMID: 15302081 [PubMed - indexed for MEDLINE]
Below is the link to Phase II of the above study and I am pretty sure they are using Enzymotec's Sharp-PS™ PLATINUM PS-DHA/EPA conjugation here (Phase II is currently in progress)...
http://clinicaltrials.gov/PS-Omega3 Supplementation to Attention Deficit Hyperactivity Disorder (ADHD) Children (ADHD-3)
This study is not yet open for participant recruitment.
Verified by Tel-Aviv Sourasky Medical Center, June 2008
Sponsors and Collaborators: Tel-Aviv Sourasky Medical Center
Enzymotec
Information provided by: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00700323
Purpose
To assess the effect of phosphatidylserine-omega-3 consumption on the immune system parameters in children suffering from attention and concentration deficits.
Condition Intervention Phase
ADHD
Dietary Supplement: PS-Omega3 conjugate supplementation
Dietary Supplement: placebo
Phase II
MedlinePlus related topics: Attention Deficit Hyperactivity Disorder Dietary Supplements
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Phase 2b Study of PS-Omega3 Conjugate Supplementation to ADHD Diagnosed Children
Further study details as provided by Tel-Aviv Sourasky Medical Center:
Estimated Enrollment: 45
Study Start Date: July 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Patients receiving active product
Dietary Supplement: PS-Omega3 conjugate supplementation
2: Placebo Comparator
Patients receiving placebo
Dietary Supplement: placebo
Eligibility
Ages Eligible for Study: 8 Years to 13 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
Parental written informed consent.
Age: 13≥ years ≥8 (including).
Gender: both male and female.
TOVA computerized test score ≤-1.8 at baseline.
Language: Subjects, parents, and teachers must be able to read, write and speak Hebrew.
Normal weight and height according to Israeli standards.
21 days without any treatment for ADHD symptoms, whether medication or food supplement.
Exclusion Criteria:
History or current diagnosis of any serious systemic (e.g., diabetes, hyper/hypothyroidism, etc.) or neurological condition (e.g., epilepsy, brain tumors, etc.)
Pervasive developmental disorder or Non-Verbal Learning Disability
Any evidence of psychotic disorders, suicidal risk, any current psychiatric co-morbidity that required psychiatric pharmacotherapy.
History of allergic reactions or sensitivity to marine products (seafood), soy or corn as well as any illness, which may jeopardize the participants health or limit their successful trial completion.
Having a sibling already included in the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700323
Contacts
Contact: Nachum Vaisman, Prof' 972-3-697-4807 vaisman@tasmc.health.gov.il
Locations
Israel
Tel-Aviv Sourasky Medical Center
Tel-Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Enzymotec
Investigators
Principal Investigator: Nachum Vaisman, Prof' Tel-Aviv Sourasky Medical Center
More Information
Responsible Party: Enzymotec Ltd. ( Yoni Manor STUDY PROJECT MANAGER )
Study ID Numbers: TASMC-08-NV-263, 263-08-TLV
Study First Received: June 17, 2008
Last Updated: June 17, 2008
ClinicalTrials.gov Identifier: NCT00700323 [history]
Health Authority: Israel: Ministry of Health
Keywords provided by Tel-Aviv Sourasky Medical Center:
ADHD
ADHD diagnosed children
Study placed in the following topic categories:
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
ClinicalTrials.gov processed this record on February 05, 2009
Edited by Visionary7903, 06 June 2009 - 12:13 PM.
