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Q. DOES EFALEX ACTIVE 50+ HAVE ANY SIDE EFFECTS?
Side effects are rare and may include nausea, soft stool, diarrhoea or other
gastrointestinal disturbances. The digestive upsets can usually be eliminated by taking the
product with food and/or reducing the dose to one capsule per day and then slowing
increasing the dose up to the maximum. People who take the product on an empty stomach
tend to have more digestive side effects.
Q. CAN I TAKE EFALEX ACTIVE 50+ WITH OTHER MEDICATIONS OR
Consult a qualified health care provider if you are taking anticoagulants or ASA. Anyone
under medical supervision or taking medication should consult their health care provider
before taking any supplement including
Efalex Active 50+®.
Ginkgo biloba may theoretically affect insulin and blood sugar levels. Therefore caution is
advised in patients with diabetes or hypoglycemia, and in those taking drugs, herbs or
supplements that affect blood sugar. Serum glucose levels may need to be monitored and
adjustment may be necessary.
Q. WHO SHOULD NOT TAKE EFALEX ACTIVE 50+?
People with blood clotting disorders who are not under medical supervision.
Q. DO YOU RECOMMEND ANY OTHER PRECAUTIONS WHEN TAKING
EFALEX ACTIVE 50+?
A. DHA -
Omega-3 (EPA+DHA) supplementation using Efalex Active 50+ is a safe form of
therapy. Occasional side effects, at high doses may include transient and short lived
gastrointestinal upsets. Intake of 2 g/day of combined EPA and DHA (i.e. 3.5 times the daily
dose in Efalex Active 50+) is similar to routine consumption in the Japanese population and
well below that of Greenland Inuit, both of whom suffer no ill effects. Moderate increases in
bleeding times, that are lower than those seen with acetylsalicylic acid (ASA/aspirin) therapy,
have been observed in individuals taking 3-4 g/day (nearly seven times the daily dose in
Efalex Active 50+). PS -
Clinical trials to confirm product efficacy have routinely included 300 mg/day of PS in
divided doses of 100 mg each – that is 5 times the daily dose in Efalex Active 50 +. These
studies reported no ill effects. The largest study, which also had the longest treatment
duration (6 months) reported no interaction with any pharmaceutical drugs that were being
used during the trial. However, patients taking antipsychotics, antidepressants, barbiturates,
methyl-dopa, reserpine and bromocriptine were excluded from the study. A trial aimed
specifically at accessing the safety of PS in humans, included up to 600 mg per day in divided
doses of 200 mg each. It reported no ill effects related to standard biochemical and
haematological safety parameters, blood pressure or heart rate and no adverse events were
reported during this trial. Long term toxicity studies using up to 70 g per day for one year
have reported no apparent damage. The United States Food and Drug Administration has
concluded that the use of PS as a dietary supplement is safe and lawful under 21 CFR
101.14 provided that bovine-derived sources, if used, are not derived from bovine tissue from
cattle born, raised or slaughtered in any country where BSE exist. Efalex Active 50+ uses soy
sourced PS. All evidence indicates that PS is safe at much higher doses than those provided
by Efalex Active 50+. Folic Acid and Vitamin B12 -
The National Academies, Institute of Medicine recommends a
Tolerable Upper Intake Level (UL) of 1000 ug/day of folate for males and females 19 years of
age and older – that is twice the daily dose in Efalex Active 50+. They currently do not
recommend an UL for Vitamin B12 because Vitamin B12 has a very low potential for toxicity.
Instead they state that "no adverse effects have been associated with excess vitamin B12
intake from food and supplements in healthy individuals". In fact, the Institute recommends that adults over 50 years of age get most of their vitamin B12 from vitamin supplements or
fortified food because of the high incidence of impaired absorption of B12 from animal foods in
this age group. The Office of Dietary Supplements, National Institute of Health recommends that older adults and vegetarians may benefit from a vitamin B12 supplement or an increased
intake of foods fortified with vitamin B12. In addition, they state that up to 30 percent of adults
50 years and older may have an overgrowth of intestinal flora that prevents normal absorption of vitamin B12 from food. Older individuals are, however, able to absorb the synthetic B12
added to dietary supplements and fortified foods. Therefore, these may be the best sources of vitamin B12 for adults over the age of 50.
Ginkgo biloba -
In large trials where people took 120 - 240 mg daily of Ginkgo biloba for up
to one year there were no serious side effects. Minor side effects included headache, nausea
and intestinal complaints. Ginkgo may interact with anticoagulants. Therefore, it is advised
not to take ginkgo if bleeding disorder exits or together with garlic, high doses of vitamin E,
acetylsalicylic acid, rofecoxib, warfarin, nonsteroidal anti-inflammatory agents, steroids and
trazodone, without monitoring platelet function as medication adjustment may be necessary.
Ginkgo may theoretically affect insulin and blood sugar levels. Therefore caution is advised
in patients with diabetes or hypoglycemia, and in those taking drugs, herbs or supplements
that affect blood sugar. Serum glucose levels may need to be monitored and adjustment may
be necessary. Use of Ginkgo is not recommended during pregnancy or breast feeding due to
lack of reliable scientific studies in this area.
Q. HOW DOES EFALEX ACTIVE 50+ DIFFER FROM OTHER PRODUCTS AIMED
AT MEMORY LOSS?
Efalex Active 50+ contains a unique mixture of ingredients that have independently been
proven to enhance mental function in aging populations. These ingredients address the two
main aspects of brain deterioration, that is, the natural structural wear and tear over time and
the potential further injury associated with vascular damage (stroke). DHA and PS address
the former while the B Vitamins and Gingko biloba benefit the latter.
Q. HOW MUCH DHA DO I NEED?
Currently most people in westernized countries eat only about 100 mg of DHA per day with many consuming significantly less
. Many expert committees and government
agencies now recognize the importance of Omega-3 fatty acids which include both DHA and
its precursor, eicosapentaenoic acid (EPA) and so have published recommendations for their
daily intake as follows:
500 mg EPA+DHA (220 mg being DHA)
500 mg EPA+DHA (120 mg being DHA)
* The International Society for the Study of Fatty Acids and Lipids ** Food Standards Agency
Q. WHAT ROLE DOES DHA PLAY IN BRAIN FUNCTION?
DHA is an important structural component of our bodies and is included in varying
concentrations in all of our cell membranes. It is one of the main fatty acids in our brain.
About 60% of the dry weight of our brain is fat and about 20% of that is DHA. DHA is also the
main component of special cells within our eyes called rod cells that absorb light and allow us
to see. A lack of DHA in either of these areas can impact on the function of these organs
which contributes to poor sight, memory, learning and co-ordination.
Q. WHAT IS PS?
Phosphatidylserine (PS) is a naturally occurring phospholipid (membrane building block)
that is part of our normal diet and is also part of our cell membranes. It is found in relatively
high concentrations in meat and fish, and to a lesser extent in milk products, beans, whole
grains and rice. Within cell membranes, it acts as an anchor to align various protein
molecules relative to their point of action and thereby enables efficient cell function.
Q. HOW MUCH PS DO I NEED?
Over the last twenty years our daily intake of PS has decreased from 250 mg to 180 mg in
a meat rich diet. Those on a reduced fat diet consume about 100 mg daily and vegetarians
eat only 50 mg per day. The effective therapeutic dose in clinical trials involving people with
moderate to severe cognitive decline is 300 mg daily. Providing 62 mg/day of PS in Efalex
Active 50+ brings the average person’s intake up from 180 mg/day to about 242 mg/day
which is near our daily intake from twenty years ago. This dose provides assurance of
sufficient PS to aid prevention of age related cognitive decline in normal populations through long term use.
Q. WHAT ROLE DOES PS PLAY IN BRAIN FUNCTION?
It makes up about 10% of the total phospholipids, but its greatest concentration is found in
myelin from brain tissue. It is the only phospholipid that carries an ionic charge which
enables its unique and essential capacity to anchor proteins within the cell membrane. These
specific PS-protein associations are essential to achieve electrical potential in membranes
and to enable movement of electrically charged particles (ions) within the neuron. Therefore,
it is a brain-specific nutrient because of its relative importance to nerve cell function.
Q. WHAT ROLE DOES VITAMIN B12 AND FOLIC ACID PLAY IN BRAIN
Vitamin B12 and folic acid work together to ensure a healthy supply of blood to the brain
which provides nutrients and oxygen essential to life. They also protect against vascular and
brain cell damage including stroke which can cause dementia.
Vitamin B12 and folic acid impact indirectly on cognitive decline through their effects on blood
homocysteine levels. Homocysteine is a substance produced in the body in association with
cardiovascular disease and its ‘destruction’ is dependent on sufficient levels of vitamin B12
and folic acid. When the levels of homocysteine are too high in the body this can induce
hardening of the arteries which can hamper blood supply to the brain. In addition, high
homocysteine levels are directly toxic to nerve cells. Therefore, keeping homocysteine levels
in check by ensuring sufficient intake of Vitamin B12 and folic acid protects nerve cell damage
resulting from stroke and prevents direct destruction of nerve cells.
Q. WHAT ROLE DOES GINGKO BILOBA PLAY IN BRAIN FUNCTION?
Ginkgo biloba extracts have been widely promoted for a variety of functions including
memory and learning enhancement, and prevention and treatment of age related cognitive
decline and dementia. Preclinical studies strongly support this use, while studies in humans
have lacked statistical requirements to achieve any definitive conclusion. However, the most
compelling evidence indicates that it may be useful as a long term preventative treatment for
dementia with some improvements possible after the development of the condition. Currently,
its mechanism of action is believed to be through multiple means with the exact nature of the
effects yet to be determined.
Nicholas Sitar Nick Sitar received his undergraduate degree in Geological Engineering from the University of Windsor in Windsor, Ontario in 1973, and his Ph.D. in Geotechnical Engineering from Stanford University in 1979. After receiving his Ph.D., he spent two years teaching in the Geological Engineering Program at the University of British Columbia in Vancouver, B.C. He joined the
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