Wednesday, July 16, 2014

Does Borage Seed Oil contain PAs (Pyrrolizidine Alkaloids)?

Borage Oil does NOT contain detectable levels of PAs (Pyrrolizidine Alkaloids), because they are not co-extracted from the seed along with the oil. In the definitive study "Pyrrolizidine Alkaloid Content in Crude and Processed Borage Oil from Different Processing Stages" published in the highly reputable Journal of the American Oil Chemists Society [JAOCS, Vol. 80, no. 10 (2003)] it was stated:

"The pyrrolizidine alkaloid content of crude borage oil and borage oil from different processing stages was determined by GC-MS. The results showed that no pyrrolizidine alkaloids were present above a detection limit of 20 ppb. The reduction factors for pyrrolizidine alkaloids at various stages in the oil refining process were determined by means of spiking experiments using the commercially available pyrrolizidine alkaloid crotaline. It was shown that the pyrrolizidine content in crude borage oil was reduced overall by a factor of about 30,000 in the refining process."

Based on the scientific evidence, since manufacturers use refined borage seed oil their Borage Oil products would never be expected to contain any measurable PAs (at the current 20 parts-per-billion detection level).

Monday, June 23, 2014

John Oliver's take on "Unregulated" Dietary Supplements

Another salvo in the War on Vitamins and Dietary Supplements:

John Oliver was funny, but not remotely fair or accurate. Some of the more grievous false examples (in my opinion):

• He assumed no new laws or regulations have been implemented since DSHEA (the Dietary Supplement Health & Education Act of 1994)
o Untrue, and some have been championed by industry; some examples:
 The 2002 Anti-Bioterrorism law's food safety regulations
 The implementation of mandatory Good Manufacturing Practices regulations and increasing numbers of FDA audits over the past 4 years
 Bans on steroids and their precursors
 A mandatory Adverse Event Reporting law
 The more recent Food Safety Law

• He showed old news reports speculating that the botanical ephedra killed 155 people, asserting that these deaths occurred because of DSHEA tying FDA’s hands
o FDA was admittedly unable to substantiate any deaths
o FDA was able to ban ephedra under DSHEA anyway based on a solely theoretical one death per year from billions of doses taken, despite two FDA expert panels unable to validate any deaths

• He claimed that FDA and FTC are powerless to act because of DSHEA, Hatch and Harkin
o The number of enforcements have been rapidly increasing
 Warning letters, recalls, even seizures
o The number of FDA inspections has been rapidly increasing

• He showed how many citizens supported DSHEA in 1993-1994, but asserted that they were misled by industry champions Senators Hatch and Harkin, who received donations from the then relatively tiny $2 billion industry
o He implied that Hatch and Harkin did it solely for the money
o He implied that Hatch and Harkin still block all regulation; see above for contrary examples
 some of the more recent laws were supported by industry and even sponsored by Hatch and/or Harkin)

• He assumed that dietary supplements are largely unregulated because of not enough regulation, rather than their relatively good safety record versus drugs or even other foods
o He promoted pre-market approval of products and claims, similar to a failed Canadian strategy that cut product selection without enhancing safety
o He cited DNA testing of botanicals failing 1/3 of products tested, without mentioning that this is actually a proposed but not yet validated assay technology disputed by herbal authorities as far too premature to use as a standard

This does not address his criticisms of Dr. Oz, who can defend himself.

Link to show:

Monday, June 16, 2014

Prebiotics (fiber) may improve metabolic factors in obese people

This is not new to me, but another study confirms that low levels of bifidobacteria are associated with obesity. This has been shown for newborns as well as adults. Consuming prebiotic fiber, i.e. inulin or FOS, can promote the growth of bifidobacteria that reduce the likelihood of obesity and its resulting symptoms/risks.

Obesity may have a microbial component. Adding prebiotic fiber plus bifidobacteria may shift metabolism toward a leaner, healthier equilibrium.

Wednesday, February 12, 2014

Facts About Xylitol

Because of recent confusion and mis-statements by some bloggers, I'd like to report some facts about the sugar alcohol, Xylitol:

Like all sugar alcohols, unabsorbed (versus undigested) material is hygroscopic (attracts water) as it passes through the GI tract. This makes them potentially laxative at various doses; as always, moderation is the key.
o For xylitol, the common threshold is at 30-50 grams a day (1-2 ounces).
o For erythritol, an alternative sugar alcohol, there is practically no laxative effect since it is predominantly absorbed.

Xylitol is naturally found in plums, raspberries, and cauliflower; it is a naturally occurring sweetener that the body can handle.

Xylitol can be made from xylan; a fiber found in many plants including:
o corn husks, cobs, and stalks (corn bobs are the leading commercial source)
o certain hardwoods like birch and beech (relatively small commercial production is done in Europe for Scandinavian trees)
o rice, oat, wheat and cotton seed hulls (possible, but not a typical commercial source)
o various nut shells (possible, but not a typical commercial source)
o straw (possible, but not a typical commercial source)
o sugar cane (possible, but not a typical commercial source)

Xylitol does not require insulin.

Xylitol improves bone and tooth density, protects tooth enamel.

Xylitol has fewer calories than sugar; only about 2.4 calories per gram versus 4 for sugar.

Most xylitol is produced in China.
o However, GMO corn is not allowed for food production in China.
o There are some IP (documented as from non-GMO corn) supplies and others tested as non-GMO (the corn sources are tested before production, though IP is not in place yet).
o GMOs have not been found in xylitol from corn, despite unsubstantiated speculation from bloggers.
o China’s food safety laws have been expanded dramatically in recent years, and in some cases now exceed US standards.

Xylitol can be toxic to dogs, but so is chocolate. Pets can’t always eat our foods, but that doesn’t imply that these foods are somehow harmful to humans. This is a “straw man” argument that fades upon examination.

Monday, January 06, 2014

Most vitamin studies are flawed by poor methodology

In a new published analysis, researchers at the Linus Pauling Institute of Oregon State University report that many large clinical trials of vitamin supplements, especially antioxidants like vitamin C, have flawed methodologies that make them 'useless' in determining the real value of such nutrients.

It is on the basis of such flawed studies created by researchers that are uninformed as to the nature of nutrients that their studies may conclude that vitamins are of no value or may even be harmful.

Of course, common sense tells us that essential nutrients cannot be inherently useless or harmful in reasonable doses, but those are messages that we repeatedly hear in the media reports.  Such flawed science leads to the equally flawed calls for vitamins to be regulated as drugs, adding a new logical error in failing to consider the vast difference in safety between nutrients and drugs.

Drugs are typically synthetic, isolated substances that are foreign to the body and don't act like nutrients, and it is this foreignness of drug properties that make them inherently toxic to the body. That toxicity is the legal basis of regulating drugs as controlled substances, and the failure to demonstrate toxicity of nutrients, except in studies with such flawed methodogies as we are discussing, makes calls to regulate vitamins as drugs hollow and illogical.

A report on that article:

The original peer-reviewed publication in a peer-reviewed nutrition journal:

Thursday, December 26, 2013

The Top Ten Vitamin Myths of 2013

The Top Ten Vitamin Myths of 2013
  1. All multivitamins are exactly the same, so a study on any one product is applicable to all other multis (ignoring variations of number of nutrients, the dose and form of each one, any supporting substances, the delivery form and excipients is good science)
  2. People take multivitamins primarily to prevent/treat cancer and heart disease (therefore any lack of definitive proof of efficacy against these diseases means that people should immediately stop taking vitamins, and all research on multivitamins is futile and should be halted even though they still are proven to prevent deficiency diseases and supply nutrients needed to preserve joint health, eyesight, healthy cholesterol and blood lipids, reduce cardiovascular risk factors, prevent birth defects, etc.)
  3. Our food supply is perfect and unchanging, as are our eating habits, making multivitamins unnecessary (Although USDA food tables were drafted around 1940, it’s okay to ignore changes in soil, seed, agriculture, food processing, how much processed and fast food we consume, the detoxification burden of environmental contaminants, and our lifestyles when telling Americans that they don’t need to supplement their diets to ensure adequate basic nutrition)
  4. Definitive answers of nutrient safety/efficacy can be found by “data mining” older studies (the practice of another team applying a “secondary data analysis” to certain fields within previously published studies in which nutrient values were reported but were not the intended research subject (“lacking depth”), and therefore all relevant variables for the nutrient(s) were probably not identified nor properly controlled as they should be in primary research)
  5. Perfect classic control groups can exist in nutrient research (obviously, this would require subjects who don’t ingest any vitamins or minerals from food  or supplements (or sunlight for vitamin D), had their serum levels at the beginning of the study measured and equalized, and had identified/controlled all co-factors that influence those nutrient levels in the body)
  6. Editorials in medical journals accurately and impartially reflect the true state of science regarding nutrient research (by honestly addressing shortcomings and limitations of the reports instead of adding their spin to well-publicized controversial articles appearing in their journal)
  7. Media coverage of vitamin controversies is always  balanced and put into proper perspective (utilizing reporters and editors who know the topic, really research stories, and present comprehensive reports)
  8. Researchers who make political statements in their reports should still be regarded as unbiased experts in nutrient study design and execution (for example, when they inaccurately state that dietary supplements are “unregulated” simply because they are not regulated as drugs it raises questions of impartiality, as well as exposing basic ignorance of the topic they claim to be experts on)
  9. A single study, especially if blending data from several other studies, can be regarded as Definitive (especially data-mining secondary data analyses that look for possible associations but lack the depth of original design to control all variables)
  10. A single study can reasonably claim to contradict decades of rigorous research (especially when it is a preliminary study not designed to screen all relevant factors that would allow it to demonstrate cause-and-effect and dose-dependent relationships)
None of these statements are true, in my opinion, but in my experience still appear to be typical operating procedures in the brave new world of research and reporting that we live in today. Questionable studies may have been designed based on questionable models, often due to ignorance or unconscious bias - even if well-intentioned

Peer reviewers for medical journals may have their own biases, ignorance, or motives for allowing statistically significant reports based on fundamentally flawed designs to be published, or for not questioning some studies' conclusions for poorly matching the reported data. 

For example, I have actually seen supplement studies reporting a conclusion that the supplements weren't effective even when the subgroup that actually followed protocol and took the supplements had success. If the overall failure of the supplements in the study were actually attributable to non-compliance subjects, that shouldn't be interpreted as the supplements being ineffective, failing the test. 

Some controversial studies are heavily marketed, even enlisting reporters to write stories based partially on sound bites and press releases in advance of embargoed reports' publication dates. Authors of controversial studies may become celebrity "experts" in the field, with their famous work widely cited by succeeding authors and being sought for media interviews during future controversies. Often, expert criticism of their work - and even failure to replicate the results in subsequent reports, a hallmark of the Scientific Method self-correcting the scientific record - typically is ignored; perhaps in light of their celebrity status.   

©2013 by Neil E. Levin, CCN, DANLA; may be cited with full attribution

Wednesday, November 06, 2013

How Important is it to have "Human Strain" Probiotics?

“Human Strain” Probiotics

The origin of a strain simply specifies from what source that particular strain - often part of a blend - was first isolated. Its origin is related to establishing intellectual property and a chain of custody, but not to any possible health benefits. There are all kinds of organisms, both desirable and undesirable, in our guts, but microbiologists do not consider the first identified/isolated source to be predictive of the health benefits that any particular strain (substrain) will provide to people.

So touting a “human source” or “soil organism” is actually a marketing game, not a valid scientific argument, and in fact is an anti-scientific message. Just because an organism was obtained from human feces (or rarely, saliva), perhaps because the person actually obtained it by eating fermented foods or even from contact with soil, doesn’t mean that it has probiotic properties…or even different properties than eating it in that yogurt or directly consuming those soil organisms. We all probably have some small quantity of E coli and Salmonella in our bowels; should they therefore be promoted as “human strain” probiotic bacteria? Obviously not…

In the scientific literature the benefits of a probiotic strain (or blend) depends solely on its technical qualities: proper identification of the specific strain (substrain), its stability in a consumer product, its bile and acid resistance, its ability to colonize and persist in the human GI tract, and any specific health effects it provides as measured in both test tube and human clinical trials when given to a human being. None of these qualities depend on its original sourcing. Specific label claims relating to substrains of probiotics depend totally on the body of clinical evidence of how that substrain provides benefits to people.

Look for the addition of a third name to the Latin binomial (2-word Latin name) of a strain to indicate a specific substrain, as in “Lactobacillus acidophilus La-14” or “Bifidobacterium lactis BL-04”.

If a company is touting the origin of their strain(s) rather than their proven clinical health benefits, then they may have no clinically validated strains and are just trying to promote theoretical rather than demonstrated benefits. Why would they promote strains based on irrelevant historical factors related to the strain's discovery rather than providing evidence of their product's demonstrated health benefits if they do have clinically relevant strains?

Smart consumers will look for evidence-based label claims, such as clinical trials utilizing their particular strain to assure that a probiotic product will have some credible evidence of being health promoting.