Is there a catch? With so many benefits is it just too good to be true? I expect that many of you reading this are asking that very question. I would and I have!
I posed this question when I was part of the team that introduced glucosamine and several other botanical medicines. I question all my patients as to how they’re doing and any possible side effects, even when prescribed what are considered the safest of natural medicines.
If I didn’t constantly question safety, I wouldn’t be doing my job. I am very pleased to tell you that as far as I can tell, inositol and Calcium/Magnesium IP6 (hereafter simply referred to as IP6) is a very safe product. A clinical setting is not the best place to test safety, but it is a good situation in which to screen for strange reactions, none of which I have yet to see.
Safety testing is best left to regulatory bodies as they consider evidence on a broad scale. Inositol is the “I” in IP6 and therefore the molecule from which IP6 is made. Inositol has been granted the GRAS status, which means it is Generally Regarded As Safe and is perhaps your greatest assurance of safety.
So many physicians consider medication for their patients using a benefit versus risk analysis, as they have come to expect that there is a down side to almost any medication.
This is simply because most drugs are new molecules and as such the body perceives them as foreign or toxic, which then leads to side effects. I would guess that most physicians would have trouble even conceiving of a medication that only produced positive results.
To make that leap many physicians would have to think of this molecule as a nutrient providing calcium, magnesium and inositol. However IP6 and inositol are much more, due largely to the fact that the phosphorylated inositols are necessary for communication within our cells. In addition, the shape of the molecule enables it to function as both a chelator and potent antioxidant.
GRAS (Generally Regarded As Safe)
As inositol and the phosphorylated inositols (IP1, IP2, IP3, IP4, IP5, IP6) are necessary and present in our blood, within all our cells and in several food sources, it’s easy to see how a GRAS designation was achieved.
The safety issue is really one of dose. How much can one take or how much should one take? These are the real questions. With the typical dosages of 1 or 2 grams daily, there is really very little need to be concerned.
Dosage becomes a concern when a patient has a very poor prognosis and wants to take as much as possible. This is a tough call. We know from a Harvard study researching kidney stones that took place more than 40 years ago, that a dose of 8.8 grams daily in divided doses resulted in no side effects or problems for patients taking the medicine for up to 2 years.
Can we give more safely? I don’t really know, but suspect based on statistics that showed that South African blacks receive up to 40.8 grams of IP6 daily when consuming 680 grams of corn, that yes, perhaps we can go higher. However, there is an important distinction to keep in mind when comparing a food versus a supplement source of IP6. As a supplement the absorption is much higher, especially if taken between meals.
The Finnish people offer further evidence as to safety. According to Weisburger et al., 1993: “The Finnish people …… because of a high cereal insoluble fiber intake, and these populations do not display any signs of mineral or vitamin deficiencies leading to abnormal growth and development”. To appreciate the importance of the above observation, one needs only to realize that “a high cereal insoluble fiber intake” implies a large amount of IP6 is being consumed.
IP6 and Bones
The most consistent concern that I hear, is a fear that the molecule could potentially cause osteoporosis because of its mineral binding or chelating properties.
This fortunately need not be a concern and in fact the opposite should be the case, if one is using the correct form of IP6 and Inositol.
The IP6 Health brand is bound to 6 atoms of calcium and magnesium, whereas IP6 can be bound to iron or sodium etc. In essence rather than deplete calcium, the right IP6 will deliver a substantial amount of calcium and magnesium.
And new research published in Dec 2008 suggests that IP6 consumption is one of the most, if not the most important nutrient for bone health. The research showed that the higher the IP6 or phytate consumption, the higher the bone density.
To further put the bone density issue to rest, one only needs to realize what happens to IP6 once ingested. The majority of the molecule is actually broken down to carbon dioxide (CO2) and expired out the lungs.
When exchanged as a gas there is no way for the metabolized or broken down molecule to bind minerals. An elaborate study was conducted to investigate IP6 breakdown and helped to establish this very point.
Researchers painstakingly grafted radioactive carbon14 (C14) into young wheat plants as part of inositol molecules, which the wheat then converted to C14 containing IP6. Then the radioactive IP6 was given to rats as part of their food.
Being radioactive the researchers were now able to trace the IP6 movement within the rats. They found that over half of the absorbed IP6 left via the lungs as CO2. At the same time the researchers varied the calcium in the rat’s diet. Amazingly the lower the calcium in the diet the more IP6 was absorbed, as if bodies instinctively know what to do.
Binding of minerals does take place, as evidenced by the ability of IP6 to influence calcium oxalate kidney stone formation. However, only a very small percentage (some estimates are 1 to 3%) actually exits via the kidneys.
Even if we assume that the higher or 3% of IP6 leaves via the kidneys, it works out that for every 33 atoms of calcium or magnesium brought into the body by IP6, only one can be removed by being bound and taken out via the urine. In other words, at the very least, the molecule brings in 33 times as much calcium and magnesium as it can take out.
One needs to keep in mind that in addition to leaving via the lungs or exiting via the kidneys that in fact, much of the IP6 is taken up and used by our cells.
IP6 is Ingested and Injected in Diagnostic Imaging
In terms of acute toxicity, the use of IP6 in several diagnostic imaging techniques provides further evidence as to its safety. There is little chance these techniques would allow IP6 to be ingested or injected if it was not found to be safe. In use for over 30 years, IP6 is now used extensively around the planet in diagnostic radiology.
IP6 is bound to various molecules such as Technetium 99, helping them to travel to various organs such as the spleen or liver.
I have found little reason to be concerned about toxicity or side effects from IP6 at normal daily dosages of 1 or 2grams, but I am cautious of its use in two primary instances. The first is with pregnancy.
Many drugs are not tested on pregnant women just in case a problem occurs, because if problems do occur, the lawsuits could be enormous. The result is that physicians often have to use their clinical judgment when it comes to prescribing during pregnancy.
When it comes to IP6, even though most women receive some in their diets, the fact is that IP6 has not been tested as a supplement during pregnancy. As an example, rather than use IP6 in supplemental form during her pregnancy, I encouraged my wife to eat IP6 containing foods such as corn.
The other instance in which I typically have patients discontinue or reduce their IP6 intake is when they are on blood thinners or are scheduled for surgery. IP6 does not “thin the blood” per se, but instead inhibits platelet aggregation or “stickiness” so that less clotting occurs in the blood vessels.
This is normally a desired effect, since it is believed that decreased platelet aggregation can help to prevent heart disease. However, in the case of a surgery, one must be careful to avoid anything that can cause excess bleeding.
Inositol is “I” in IP6 and is often referred to as the “mother” of IP6. It also provides the base structure for the IP6 molecule.
They are combined together in the IP6 Health formula, as they have been proven in a number of research studies to complement and augment each other’s effects. The Physicians’ Desk Reference Family Guide to Nutrition and Health (1995) says that inositol has not been found to be toxic at any dosage level. Michael Lesser, M.D. has stated that: “as much as 50grams (50.000milligrams) has been taken by mouth with no ill effect.”