Amazing Nutrition
for the Brain

Medical Report

Nutrition Main Page

Product Availability Can Benefit Millions

There is an impressive body of scientific and clinical research that has been conducted on phosphatidylserine(PS) in the microbiological neurochemical, animal study and human clinical study areas. Both animal studies and human clinical trials verify the positive effects of PS upon memory and learning performance functions. In layman's terms, PS has the effect of improving memory and cognitive (learning and problem-solving)functions. It has been shown to significantly improve such functions as remembering names and numbers, remembering frequently misplaced items and improving the learning of new tasks and knowledge. Memory performance appears to begin to improve to a noticeable and statistically significant degree starting in about 2 weeks, if PS is taken daily.

Prior to the 1992 introduction of PS concentrated from soy lecithin, the only commercially available PS was derived from cow's brain. The problem with cow's brain PS was the danger of virus contamination("mad cow's disease") which made it impossible to get government approval to sell freely.

The manufacturer of the Memoraid TM formulation was the first company in the world to produce phosphatidylserine derived from vegetable matter - the common foodstuff soy lecithin, The availability of a PS product derived from a plant source therefore eliminated the greatest roadblock to this product being available to the general public - the danger of viral contamination. PNK International.,Inc. is one of the first companies to introduce this plant PS formulation to the world market and Memoraid TM is the first plant PS brand available to multiple national markets outside Europe.

Now consider the implications of the availability of the Memoraid TM PS product in terms of the huge potential consumer base in America and other markets.

Phosphatidylserine is an unusual nutritional supplement in that it is one of the few products that is backed by over twenty human clinical studies conducted by universities, medical schools and hospitals. Over half of these trials were "double blind" clinical which means they were conducted strictly like those studies conducted to approve new drugs. These studies prove that phosphatidylserine(PS) improves memory and cognitive functions in older adults.

These clinical studies mostly focused on persons whose cognitive and memory function had already deteriorated to the point where they could be clinically diagnosed as suffering from senile dementia or Alzheimer's Disease. What is extremely important in assessing the commercial potential of the Human Potential Products Memoraid TM product is its broader market potential for a larger more healthy population. Memoraid TM is appropriate for introduction not only to individuals in the early stages of senile dementia or Alzheimer's disease. Consider the product's appeal for a larger, often younger and otherwise brain healthy population defined by the broader concept of " Age-Associated Memory Impairment" or AAMI.

Memory function naturally deteriorates in humans from about the age of 30 years as the brain physically ages. For instance, there is an increasingly diminished activity of acetylcholine which is a neurotransmitter (allowing the individual brain cells to "talk" with each other). Acetylcholine is known to be involved in learning and memory. Animal studies show that phosphatidylserine(PS) increases acetylcholine in the brain and also prevents nerve-cell deterioration.

The concept of memory function improvement in otherwise healthy individuals is therefore key in highlighting Memoraid TM as the basis for a wholly natural over-the-counter nutritional supplement with a broad consumer appeal base.

The US Census Bureau showed that in 1994 there were 53.1 million people in the USA aged 40-59 years. The majority of these individuals are daily in the work force and subject to the tremendous strains and pressure that now require almost constant adaptation and the learning of new skills. The same census figures show that there are 28.7 million American aged 60-74 years of age, and 13million aged 75+ years. These older Americans are the most susceptible to Age-Associated Memory Impairment at the same time that the changing economic and governmental environments in which they live are becoming less supportive. The premium on continued independence and staying in the work force longer marks the ability to cognitively function even more important today for these older Americans.

The proportion older people is rising steadily at a time when society is growing more complex and hostile to the mature adult. The need to maintain and prolong independence has never been more important. This independence often requires working as long as possible as well as prolonging the ability to maintain one? s own home and daily life routine.

The key ingredients in Memoriad TM can improve and maintain memory and mental function, and promote positive emotional balance. Memoraid TM can be particularly rewarding for older men and women who are neurologically healthy. The more capable persons are to deal with the demands of daily living the more rich will be their life. Enhancement and maintenance of memory function are vital for independent life now and into the retirement years.

For less fortunate individuals and families whose loved ones are entering a state of senile dementia or Alzheimer's Disease, the issues of independence are more basic. Memoriad TM is not a cure for such maladies, which are progressive diseases of the brain. However, a number of clinical studies do show that persons who suffer the early stages of senile dementia can be helped by PS as found in Memoraid TM. Improvement is particularly dramatic in terms of being able to again perform the most essential daily functions such as dressing, feeding oneself and taking care of own toilet needs. It is difficulties in these areas which often require the relocation of the afflicted individual to a care facility such as a nursing home.

The workplace of today represents for many persons unprecedented demands, challenges and new kinds of stress. Competitive pressures on a global scale, corporate downsizing and complex new technologies are all very potent agents of change. As we approach the 21st Century the pace of change and uncertainty will only continue to accelerate.

This reality requires men and women to learn new skills and manage more complex tasks. At the same time they must absorb and process vastly increased data and knowledge. Memoraid TM can help the business man and woman of middle years to adapt and increase productivity. Learning and memory function flexibility is crucial. Evens for healthy persons the natural aging of the brain causes progressive deterioration of the memory and learning functions. This process starts from around 30 years of age and continues into old age. The result is that by the time the average person reaches age 65 they have lost as much as half of their memory retention ability. Memoraid TM PS supplements your body's natural PS with the result that you are able to learn new tasks and routines more quickly and thoroughly.

Memoraid TM is the essential all-natural brain nutrient for men and women in business. Memoraid TM to learn and focus like yesterday!

 

Unique Features of Memoraid TM

Memoraid TM is backed by a double-blind clinical study which revealed significant cognitive function improvement and improvement in mood. (See pages 10-11).

Memoraid TM is the only soy lecithin formulation which has been on the market since 1992. It represents a 4-year history of proven stability, integrity and safety.

Memoraid TM is manufactured using a wholly natural enzymatic process which does not use induced catalyst bacteria. It is therefore very clean and completely void of possible microbiological contamination as are competitive products. Also unlike the competition our manufacturing process makes make no use of artificial chemical solvents. Memoraid TM therefore contains no hexane (a chemical solvent).

Memoraid TM is the only formulation which delivers high percentage of phosphatidic acid (PA) in addition to the 100mg of PS in each capsule. Its other key ingredients are amino acid L-serine and vitamin C. Included by rational design, these secondary key ingredients make the Memoraid TM unique and are implicated in both anecdotal (beta site) and clinical study conclusions as to memory function and mood improvement characteristics.

 

Key Ingredient - Phosphatidic Acid (PA)

Phosphatidylserine (PS) and Phosphatidic Acid (PA) are naturally occurring phospholipids which are biochemically linked through the activity of the enzyme phospholipase D. PS has been thoroughly investigated with relation to neurological functions and it is now well documented that oral consumption of PS can rectify brain functions like memory, and is of clear beneficial effect in aging subjects. PA has been shown to act as an important activator of various cellular functions and in this respect may counteract tissue deterioration or degradation which take place in aging. It may similarly support tissue building. The biochemical relationship between PS and PA strongly suggests that they are synergistic in their action. The Memoraid TM formulation contains as active ingredients roughly equal amounts of PS and PA. The results of the clinical trial with the Memoraid TM formulation strongly suggest that this combination is superior to PS alone. Other active ingredients which are included in Memoraid TM are amino acid L-serine and vitamin C.

 

Selected References - Phosphatidic Acid:

$Liscovitch,M.and Chalifa, V. (1994) Signal - activated Phospholipase D. in Signal-activated Phospholipases. (R.G. Landes Comp.),p.31

$Moolenaar W.H. et.al (1992) Lysophosphatidic Acid: A Bioactive Phospholipid with Growth-like Properties. Rev.Physiol. Biochem. Pharmacol. 119, p. 47.

$Cano,E. et.al. (1992) Regulation of IL-2 Response by Phosphatidic Acid.. Eur.J. Immunol..22,1883.

$Moritz, A. et.al (1992) Phosphatidic Acid is a Specific Activator of Phosphatidyl inositol - 4 Phosphate Kinase. J. Biol. Chem. 267, p. 7207.

$Metz,S.A. et.al. (1990) Stimulation of Insulin Release by Phospholipase D. A Potential Role for Endogenous Phosphatidic Acid in Pancreatic Islet Function. Biochem. J. 270, p. 427.

$Lavie, Y. and Liscowitch, M. (1990) Activation of phospholipase D by sphingoid bases in NG108-15 neural-derived cells. J. Biol. Chem. 265(7), pp. 3868-72.

 

Clinical Backing for Phosphatidylserine (PS)

Phosphatidylserine (PS) is a naturally occurring phospholipid nutrient. PS is essential to the functioning of all the cells of the body where it is found in the membrane (or outer surface) of the cell. However the body concentrates most of the PS in the brain where its abundance reflects its proven involvement in an assortment of nerve cell functions, including synaptic activity and nerve transmitter release. Clinical studies have strongly suggested that PS can support brain functions that tend to deteriorate with the natural aging of the brain. Until recently PS was only available from Cow's brain and in commercial soy lecithin only in trace amounts (about 0l.2-0.5% by weight). However starting in 1992 a plant source for PS was developed based upon Israeli research. This PS is derived from the recognized and widely used foodstuff - soy lecithin. Soy lecithin itself is derived from soy beans.

This contribution of PS at the level of the individual brain cell is expressed in the overall performance of the brain. Human clinical trails starting in the early 1980's have clearly and consistently indicated that is PS is taken as a dietary supplement, it can benefit a range of cognitive functions. We have records of over 20 human studies of PS, of which 13 were conducted double-blind. "Double-blind" is the type of clinical trail that pharmaceutical companies conduct which testing a new drug. The scientific evidence for the effectiveness of PS as a nutritional supplement is therefore strong, widespread and convincing.

U.S. Census data indicates that there are more than 40 million people in America over 59 years of age. More than half of these are likely experiencing impaired capacity to recall names and numbers, to manipulate words or to concentrate and stay focused on tasks. Progressive loss of mental functions can have a negative effect on productivity in the workplace, diminish lifestyle independence, increase frustration and lessen self-esteem of aging adults.

 

Double-Blind Clinical Trials With PS

The two key aspects of higher-level mental functions are memory and cognition. (Cognition is defined as the ability to think and reason). It is inevitable that as humans age they lose some sharpness and speed in these functions, which have been found to decline during middle-age and later life. This decline is inevitable and is associated with the natural aging of the brain. As nerve cell density falls both in terms of the number of cells and also in the density of the synaptic connections within the cell network of the brain, so declines cognition and memory. It is therefore a process that occurs even in other wise healthy individuals.

This decline can begin as early as the third decade of life and over the adult life span healthy individuals can lose as much as half of their ability to perform every day tasks related to memory and cognition. The good news is that clinical trials conducted in the US, Europe and Israel indicate that taking PS as a dietary supplement can play an important part in the support of mental functions in the aging brain.

Among the clinical trials conducted with PS, most were conducted with subjects who had experienced losses in memory, judgment and abstract thought to a degree that could be objectively measured by testing. These subjects also sometimes were diagnosed as having suffered changes in personality and behavior. The basis for the clinical trials was to define categories of affected functions and then using test to measure them. These changes were recorded on the tests over time within both the group that was receiving PS daily and those who were receiving a placebo (sugar pill). We will summarize 3 of the more important and substantive of these clinical studies.

1993 Study (Israel), Gindin et.al. This study was conducted by Dr. J. Gindin and his associates of the Geriatric Institute for Education and Research, Kaplan Hospital (Rehovot, Israel). This double-blind clinical study used to PS formulation found in Memoraid TM.

This study focused upon 57 subjects aged 60-80 years and was conducted as a randomized double-blind study. Subjects were divided into PS treatment and placebo groups, and the treated group was given daily doses of 300mg [3 capsules Memoraid TM] for a period of 3 months. Individuals who were clinically diagnosed as depressed were excluded, as were those suffering from any active or recent major disease or who were taking medications such as sedatives, tranquilizers, or others that influence memory. Subjects were assessed in terms of cognitive function and mood prior to the study, and after taking the PS (or placebo) for 12 weeks.

Gindin,J.et.al., 1992. The effect of plant phosphatidylserine on age associated memory impairment and mood in the functioning elderly. The Gerontologist. Vol. 33.

 

This results of the clinical study showed that individuals who had higher cognition and memory scores before the test exhibited the most significant improvement after taking PS for 3 months. These individuals who were basically healthy, but experienced some difficulty with memory in their daily lives, showed significant improvement in terms of several components of memory and cognition functions.

These were characterized by the researchers as showing "highly significant change" after taking the Memoraid TM formulation:

(A) memorizing stories

(B) visual memory

(C) memorizing numbers

(D) memorizing pairs of words

(E) counting backwards

(F) saying the alphabet

(G) processing information

 

Their conclusion was that PS has a particularly strong and positive affect on individuals who suffer from some age-associated memory impairment, but for whom this impairment has not yet reached the degenerative state. This study therefore confirms the proposition that PS is suggested as being effective in the enhancement, or rollback, of memory and cognitive deterioration while maintaining mental function.

Mood was also assessed after PS administration using the List of Depressive Symptoms test. The results of mood assessment showed that the placebo group experienced a significant increase in depressive symptoms whereas those who took the PS revealed no significant change. The course of the study included the onset of winter, when older persons are most susceptible to develop feelings of depression. The onset of these "winter blues" was completely blocked among ALL INDIVIDUALS in the study who were taking the Memoraid TM formulated PS.

1991 Study (USA), Crook et.al. This study was conducted by Dr. T. Crook of the Memory Assessment Clinics (Bethesda, Maryland) along with clinicians from the Vanderbilt University School of Medicine (Nashville Tennessee) and the Stanford University School of Medicine(Palo Alto, California).

149 persons aged 50-75 were studied. PS was given at a daily dosage of 300mg per day [3 Memoraid TM capsules] versus a placebo, for a period of 3 months. The subjects were tested at the beginning of the study, then after 3 weeks, 6 weeks, 9 weeks, 12 weeks and then 4 weeks after they stopped taking the PS. The subjects?compliance with taking the treatment was good and there were no side effects reported. By the first evaluation period at 3 weeks trends were noted in three of the five primary variables, all favorable for PS:

(A) learning names and faces

(B) recalling names and faces

(C) facial recognition

 

These trends were not however substantiated for the trail's entire 3 months. To achieve a more meaningful assessment the researchers focused on a sub-group of 57 persons who were relatively more memory-impaired and older, with an average age of 64.3 years. They seemed to benefit more from taking the PS, and were found to have improved significantly in terms of the above three variables by the end of the test period. The improved facial recognition also continued 4 weeks after they had stopped taking PS. This group of older persons also demonstrated significant improvement in terms of

(D) misplaced objects recall

(E) telephone number recall

(F) ability to concentrate while reading, conversing, doing tasks

(G) paragraph recall

Crook,T.H. et.al.1991. Effects of phosphatidylserine in age- associated memory impairment. Neurol. 41:644-649.

 

In addition, to these improvements, this older group of subjects showed overall improvement in cognitive status after 12 weeks of taking PS, as determined by interview. The researchers concluded that PS might prove clinically valuable for older persons suffering from some loss of mental function. As their models, they took the " learning names and faces" factor where PS improved the older sub-group's performance by an average of two points. The researchers calculated that for this parameter of higher mental function, PS had "rolled back the clock" by roughly 12 years. In other words, from being at a cognitive age of 64 years, the subjects were restored, on average, to a cognitive age of 52!

1992 Study (USA), Crook et.al. This study was conducted by Dr. Crook's Memory Assessment Clinics along with clinicians from the Vanderbilt University School of Medicine (Nashville, Tennessee).

51 persons from age 55-85 were studied, with average age of 71. This study was also double-blind with a daily dosage of 300mg PS [3 capsules of Memoraid TM]. Subjects were given PS or a placebo for 3 months. Assessments were conducted at 3, 6, 9 and 12 weeks.

Crook,T.H. et.al., 1992. Effects of phosphatidylserine in Alzheimer s disease. Pschopharmacol.Bull. 28:61-66.

By the end of three months the subjects who had taken PS showed statistically significant improvements in terms of:

 

recall of the location of frequently misplaced objects

recall of details of events from the previous day

recall of details of events from within the past week

memory for names of familiar persons and clinical staff

 

As in the 1991 study, the researchers again identified a subgroup who derived additional benefits from taking PS. This subgroup had relatively mild cognitive impairment, as compared with the entire test group. Th3e individuals within this group who took the PS significantly benefited on the variables above and on 2 others:

 

ability to maintain concentration

two measures of overall improvement in cognitive status

 

When tested against a psychiatric rating scale, this subgroup of mildly impaired individuals improved on 5 of the 7 cognitive functions. On 4 of these 5 functions, improvement was noticeable as early as 3 weeks after starting to take PS. As in the two previous studies, these results suggest that PS can benefit particular aspects of cognitive functioning in those persons who are still only mildly impaired.

 

* * *

 

Selected European Double-Blind Clinical Studies with PS

 

Palmieri, G. et,al., 1987. "Double-blind Controlled trail of phosphatidylserine in subjects with senile mental deterioration." Clin. Trials J. 24: 73-83.

Amaducci, L. et.al 1988. "Phosphatidylserine in the dosing of Alzheimer's disease: results of a multicenter study." Psychopharmacol. Bull. 24: 130-134.

Cenacchi, B. et.al. 1993. "Cognitive decline in the elderly: A double-blind, placebo-controlled multicenter study on efficacy of phosphatidylserine administration." Aging Clin. Exp. Res. 5:123-133.

Delwaide, P.J. et.al. 1986. "Double-blind randomized controlled study of phosphatidylserine in demented subjects." Acta Neurol. Scana.. 73: 136-140.

Engel, R.R. et.al. 1992 "Double-blind cross-over study of phosphatidylserine vs. Placebo in subjects with early cognitive deterioration of the Alzheimer type." Eur. Neuropsychopharmacol. 2: 149-155.

Villardita, C. et.al. 1987. "Multicentre clinical trial of brain phosphatidylserine in elderly subjects with mental deterioration." Clin. Trials J. 24: 84-93.

 

Safety of Memoraid TM

As discussed earlier, phosphatidylserine (PS) has been used in a large number of clinical studies - at least 23 to date. It has emerged from this wide-ranging clinical scrutiny with an excellent safety record. No danger is evident from long-term use of PS. Cenacchi and his associates reviewed laboratory findings from 130 subjects who ingested 300mg of PS for 60 days during clinical trials. They found that uric acid levels were lowered but that this was clinically insignificant. In his larger 1993 study involving 425 subjects for 6 months, Cenacchi concluded that "... dverse effects were very few, and clinically unimportant. These observations are remarkable in the light of the large number of subjects enrolled in this study, who represent a sample of the geriatric population commonly encountered in clinical parctice." [emphasis added]

A review of the other clinical studies confirms Cenacchi's observations that no clinically significant adverse reactions were observed. In rare cases individuals may suffer mild nausea if they take a larger single dose of PS. However, this effect can be minimized by taking Memoraid TM with meals. Taking Memoraid TM before going to bed may delay falling to sleep.

Toxicology studies were also conducted on rats and dogs which indicate that PS is safe taken orally. Dogs fed 70 grams of PS per day (233 times human dose), for a year, suffered no apparent damage.

Cenacci, B.et.al. 1987. Human tolerability of oral phosphatidylserine assess through laboratory examinations. Clin. Trials. 24: 125-130.

Cenacchi, B. et.al. 1993. Cognitive decline in the elderly: A double-blind, placebo-controlled multicenter study on efficacy of phosphatidylserine administration. Aging Clin. Exp.Res. 5: 131.

Heywood,R. et.al. Toxicology of a pohosphatidylserine preparation from bovine brain(BC-PS). Clin. Trials j. 24: 25-32.

 

Memoraid TM Product Specifications

 

HARMONIZED TARIFF SYSTEM (HTS)CLASSIFICATION

" Neuro-Nutrition TM " and " Memoraid TM " is classified under the HTS as "2923.20.2000 Lecithin and Other Phosphoaminolipids".

PRODUCT CODE

Each bottle of Memoraid TM bears the UPC bar code ident 11310 57771.

GENERAL SPECIFICATIONS

General: Memoraid TM contains soy lecithin enriched with phosphatidylserine by enzymatic processing. Memoraid TM is produced in a tablet containing 545mg of formulation, including 100mg of phosphatidylserine.

Composition per each Capsule:

 

Ingredient

Weight

Phosphatidyl serine (PS)

100 mg

other Phospholipids and Glycerides (incl. PA)


230 mg

Vitamin C

12 mg

Amino acid L-serine

50 mg

Magnesium Stearate

45 mg

Corn Starch

91 mg

Silicon Dioxide

17 mg

Total:

545 mg

 

Accuracy tolerance of each ingredient is in range +5%

 

Moisture (maximum): 1.0%

Appearance: light brown Oval Capsule

 

MICRO BIOLOGICAL ANALYSIS

 

Total colony forming units (CFU): <1000/gram

Yeast: 100 CFU/gram max.

Mold: 100 CFU/gram max.

Coliforms: <10 per gram

E. Coli None Detected

Salmonella None Detected

Staphylococcus None Detected

 

MATERIALS

All Materials used in the production are common in foodstuffs:

 

Lecithin: Granulated soy lecithin for human consumption, a world-wide registered foodstuff.

L-serine: This is an essential amino acid in human nutrition, recognized as a foodstuff according to E.E.C. regulations. L-serine occurs naturally in large amounts in the human body and is consumed daily in large quantities from any foodstuff which includes proteins such as cheese, meat, eggs, nuts, etc.

Phospholipase D: Freshly prepared before each production from the inner leaves of Savoy cabbage as described by Eibl and Kovatchev.

Salts and beffers: Include sodium and calcium chloride and carbonate.

"GREEN" RATING

Memoraid TM contains neither artificial preservatives nor chemical solvents.

BOTTLE FILL

Sixty (60) Capsules, each 545mg. Net weight of contents is 32.7 grams.

SHELF LIFE

Two (2) years at temperature below (<) 35 C.

CONSUMER DOCUMENTATION

The label on each bottle of Memoraid TM is clearly stamped with Production Lot Number and Expiration Date (month/year).

SAFETY SEALED

Each bottle is delivered with a study, integral safety seal ring to prevent tampering. This 360 degrees plastic ring must be removed with deliberate force, using both hands, in order to unseal and open the bottle. Once open, the bottle is not child resistant.

RECOMMENDED USE

Two to three tablets of Memoraid TM, delivering 200-300mg of phosphatidylserine, daily, as a nutritional supplement.

HAZARD SUMMARY

All ingredients of the product are biologically compatible and do not bear any known explicit toxic potential. There are no known counterindications to use of Memoraid TM by individuals suffering specific complaints such as cardiovascular disease or diabetes. The product has no fire or explosion hazard and is chemically inert.

TRADEMARKS

Neuro-Nutrition TM and Memoraid TM are registered in the United States of America and Korea as trademarks of WESTWOOD Industries & PNK International., Inc. Salt Lake City, Utah, USA.

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