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.

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.

People with blood clotting disorders who are not under medical supervision.

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.

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.

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:

* The International Society for the Study of Fatty Acids and Lipids
** Fod Standards Agency

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.

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.

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.

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.

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.

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.