Clinical Study Νο 1
The Clinical Study: “A novel oral nutraceutical formula of omega-3 and omega-6 fatty acids with vitamins (PLP10) in relapsing remitting multiple sclerosis: a randomised, double-blind, placebo-controlled proof-of-concept clinical trial” was performed from July 2007 until December 2010, according to the global standards of clinical research for the disease and with the participation of 80 patients with relapsing multiple sclerosis. The study design and the medical protocol included many innovations leading to the preparation of the formulation. Unlike anything else available, this formulation (with the code PLP10) is a nutraceutical (with natural biomolecules), administered orally, can be co-administered with all other available treatments, showed great therapeutic effect in reducing the frequency of relapses (flares) of the disease but mainly on the progression of the disability of patients. Moreover, it is potentially able to trigger remyelination, neuroprotection and mainly free of side effects.
Due to the multiple ingredients consisting the formulation has the ability to influence a holistic treatment of the disease and is able to affect the total known biological and biochemical network of pathogenic/pathogenetic events and mechanisms that cause the disease, including the biochemical mechanisms responsible for remyelination and restoration of neurons (healing). In more detail, the formulation by the code PLP10, versus placebo showed significant healing abilities for the sample of patients in the study, reducing the frequency of relapses of the disease up to 72% and the possibility of disability progression up to 86% without any severe side effects. The formulation itself, as well as the new therapeutic philosophy of holistic approach to the disease by systems medicine through systems Biology is a formidable light-beam for persons suffering with this incurable chronic disease and not only. There are multiple scientific evidence for use of the formulation for other neurodegenerative diseases such as Parkinson’s, Alzheimer’s etc. Finally, the profile and safety of the intervention/formulation PLP10 makes it engaging enough for usage as a prevention food supplement formula for diseases of the central nervous system in general, and more specifically for patients with the Clinically Isolated Syndrome (CIS), i.e. with the first stroke of MS or even for chronic neurodegenerative diseases such as Alzheimer’s disease, the greatest scourge of mankind today.
Clinical Study Νο 2
The aim of the present study was to examine the effects of a high-dose omega-3 and omega-6 fatty acids supplementation, in combination with antioxidant vitamins, on cognitive function and functional capacity of older adults with mild cognitive impairment (MCI), over a 6-month period in a randomized, double-blind, placebo-controlled trial. Forty-six older adults with MCI (age: 78.8 ± 7.3 years) were randomized 1:1 to receive either a 20 mL dose of a formula containing a mixture of omega-3 (810 mg Eicosapentaenoic acid and 4140 mg Docosahexaenoic acid) and omega-6 fatty acids (1800 mg gamma-Linolenic acid and 3150 mg Linoleic acid) (1:1 w/w), with 0.6 mg vitamin A, vitamin E (22 mg) plus pure γ-tocopherol (760 mg), or 20 mL placebo containing olive oil. Participants completed assessments of cognitive function, functional capacity, body composition and various aspects of quality of life at baseline and following three and six months of supplementation.
Clinical Study Νο 3
Patients with multiple sclerosis (MS) are characterized by, among other symptoms, impaired functional capacity and walking difficulties. Polyunsaturated fatty acids (PUFAs) have been found to improve MS patients’ clinical outcomes; however, their effect on other parameters associated with daily living activities need further investigation. The current study aimed to examine the effect of a 24-month supplementation with a cocktail dietary supplement formula, the NeuroaspisTM PLP10, containing specific omega-3 and omega-6 PUFAs and specific antioxidant vitamins on gait and functional capacity parameters of patients with MS. Fifty-one relapsing-remitting MS (RRMS) patients with low disability scores (age: 38.4 ± 7.1 years; 30 female) were randomized 1:1 to receive either a 20 mL daily dose of the dietary formula containing a mixture of omega-3 and omega-6 PUFAs (12,150 mg), vitamin A (0.6 mg), vitamin E (22 mg), and γ-tocopherol (760 mg), the OMEGA group (n = 27; age: 39 ± 8.3 years), or 20 mL placebo containing virgin olive oil, the placebo group (n = 24; age: 37.8 ± 5.3 years). The mean ± SD (standard deviation) Expanded Disability Status Scale (EDSS) score for the placebo group was 2.36 and for the OMEGA group 2.22. All enrolled patients in the study were on Interferon-β treatment. Spatiotemporal gait parameters and gait deviation index (GDI) were assessed using a motion capture system. Functional capacity was examined using various functional tests such as the six-minute walk test (6MWT), two sit-to-stand tests (STS-5 and STS-60), and the Timed Up and Go test (TUG). Isometric handgrip strength was assessed by a dynamometer. Leg strength was assessed using an isokinetic dynamometer. All assessments were performed at baseline and at 12 and 24 months of supplementation. A total of 36 patients completed the study (18 from each group). Six patients from the placebo group and 9 patients from the OMEGA group dropped out from the study or were lost to follow-up. The dietary supplement significantly improved the single support time and the step and stride time (p < 0.05), both spatiotemporal gait parameters. In addition, while GDI of the placebo group decreased by about 10% at 24 months, it increased by about 4% in the OMEGA group (p < 0.05). Moreover, performance in the STS-60 test improved in the OMEGA group (p < 0.05) and there was a tendency for improvement in the 6MWT and TUG tests. Long-term supplementation with high dosages of omega-3 and omega-6 PUFAs (compared to previous published clinical studies using PUFAs) and specific antioxidant vitamins improved some functional capacity and gait parameters in RRMS patients.
