Tag Archives: PREDIMED

Dr. P’s Heart Nuts and The Flawed But Still Relevant PREDIMED Trial

The skeptical cardiologist was somewhat disheartened to read  the New York Times headline today that the  PREDIMED study was flawed. I frequently reference this landmark randomized trial of the mediterranean diet when I’m citing the cardiovascular benefits of nuts and EV olive oil.

Science mag summarizes the problem which prompted a re-analysis of the study:

A months-long inquiry by the Spanish researchers and NEJM staff uncovered that up to 1588 people in the trial hadn’t been properly randomized: Some were assigned to the same diet as someone else in their household (a common feature of diet studies, but not reported in the original paper). Others, who lived in a rural area, were assigned to different diets based on the clinic closest to them—for example, one group had to pick up a liter of olive oil each week. “The investigator realized he couldn’t get people to travel as far as they needed so he made his study ‘cluster randomized,’” by clinic rather than by individual, Drazen says.

The authors reanalyzed their data without those 1588 participants and found that despite the missteps, the conclusion held: Nuts, olive oil, and fatty fish remained a net positive on heart health, though the conclusions came with somewhat less statistical oomph than in the original paper.

Here’s what I wrote about nuts and the PREDIMED study when I first started distributing Dr. P’s Heart Nuts to my patients.

The skeptical cardiologist has finally prepared Dr. P’s Heart Nuts for distribution. IMG_8339The major stumbling block in preparing them was finding almonds which were raw (see here), but not gassed with proplyene oxide (see here), and which did not contain potentially toxic levels of cyanide (see here).

During this search I learned a lot about almonds and cyanide toxicity, and ended up using raw organic almonds from nuts.com, which come from Spain.

I’ll be giving out these packets (containing 15 grams of almonds, 15 grams of hazelnuts and 30 grams of walnuts) to my patients because there is really good scientific evidence that consuming 1/2 packet of these per day will reduce their risk of dying from heart attacks, strokes, and cancer.

IMG_7965The exact components are based on the landmark randomized trial of the Mediterranean diet, enhanced by either extra-virgin olive oil or nuts (PREDIMED, in which participants in the two Mediterranean-diet groups received either extra-virgin olive oil (approximately 1 liter per week) or 30g of mixed nuts per day (15g of walnuts, 7.5g of hazelnuts, and 7.5g of almonds) at no cost, and those in the control group received small nonfood gifts).

After 5 years, those on the Mediterranean diet had about a 30% lower rate of heart attack, stroke or cardiovascular death than the control group.

It’s fantastic to have a randomized trial (the strongest form of scientific evidence) supporting nuts, as it buttresses consistent (weaker, but easier to obtain), observational data.

Despite the statistical flaws PREDIMED is still an important study demonstrating the benefits of nuts.  PREDIMED was the best randomized trial data we had for nuts but there are tons of observational data which are very consistent and show a strong association between increased nut consumption and reduced mortality..

Consequently, I made up a new batch of Dr. P’s Heart Nuts in honor of the survival of PREDIMED and will be distributing them to patients today.

Meditativeterraneanly Yours,

-ACP

Dr. P’s Heart Nuts: Preventing Death In Multiple Ways

The skeptical cardiologist has finally prepared Dr. P’s Heart Nuts for distribution. IMG_8339The major stumbling block in preparing them was finding almonds which were raw (see here), but not gassed with proplyene oxide (see here), and which did not contain potentially toxic levels of cyanide (see here).

During this search I learned a lot about almonds and cyanide toxicity, and ended up using raw organic almonds from nuts.com, which come from Spain.

I’ll be giving out these packets (containing 15 grams of almonds, 15 grams of hazelnuts and 30 grams of walnuts) to my patients because there is really good scientific evidence that consuming 1/2 packet of these per day will reduce their risk of dying from heart attacks, strokes, and cancer.

IMG_7965The exact components are based on the landmark randomized trial of the Mediterranean diet, enhanced by either extra-virgin olive oil or nuts (PREDIMED, in which participants in the two Mediterranean-diet groups received either extra-virgin olive oil (approximately 1 liter per week) or 30g of mixed nuts per day (15g of walnuts, 7.5g of hazelnuts, and 7.5g of almonds) at no cost, and those in the control group received small nonfood gifts).

After 5 years, those on the Mediterranean diet had about a 30% lower rate of heart attack, stroke or cardiovascular death than the control group.

It’s fantastic to have a randomized trial (the strongest form of scientific evidence) supporting nuts, as it buttresses consistent (weaker, but easier to obtain), observational data.

Trademark

I applied for a trademark for my Heart Nuts, not because I plan to market them, but because I thought it would be interesting to possess a trademark of some kind.

The response from a lawyer at the federal trademark and patent office is hilariously full of mind-numbing and needlessly complicated legalese.

Heres one example:

"DISCLAIMER REQUIRED
Applicant must disclaim the wording “NUTS” because it merely describes an ingredient of applicant’s goods, and thus is an unregistrable component of the mark.  See 15 U.S.C. §§1052(e)(1), 1056(a); DuoProSS Meditech Corp. v. Inviro Med. Devices, Ltd., 695 F.3d 1247, 1251, 103 USPQ2d 1753, 1755 (Fed. Cir. 2012) (quoting In re Oppedahl & Larson LLP, 373 F.3d 1171, 1173, 71 USPQ2d 1370, 1371 (Fed. Cir. 2004)); TMEP §§1213, 1213.03(a).

The attached evidence from The American Heritage Dictionary of the English Language shows this wording means “[a]n indehiscent fruit having a single seed enclosed in a hard shell, such as an acorn or hazelnut”, or “[a]ny of various other usually edible seeds enclosed in a hard covering such as a seed coat or the stone of a drupe, as in a pine nut, peanut, almond, or walnut.”  Therefore, the wording merely describes applicant’s goods, in that they consist exclusively of nuts identified as hazelnuts, almonds, and walnuts.

An applicant may not claim exclusive rights to terms that others may need to use to describe their goods and/or services in the marketplace.  See Dena Corp. v. Belvedere Int’l, Inc., 950 F.2d 1555, 1560, 21 USPQ2d 1047, 1051 (Fed. Cir. 1991); In re Aug. Storck KG, 218 USPQ 823, 825 (TTAB 1983).  A disclaimer of unregistrable matter does not affect the appearance of the mark; that is, a disclaimer does not physically remove the disclaimed matter from the mark.  See Schwarzkopf v. John H. Breck, Inc., 340 F.2d 978, 978, 144 USPQ 433, 433 (C.C.P.A. 1965); TMEP §1213.

If applicant does not provide the required disclaimer, the USPTO may refuse to register the entire mark.  SeeIn re Stereotaxis Inc., 429 F.3d 1039, 1040-41, 77 USPQ2d 1087, 1088-89 (Fed. Cir. 2005); TMEP §1213.01(b).

Applicant should submit a disclaimer in the following standardized format:

No claim is made to the exclusive right to use “NUTS” apart from the mark as shown."

I’ve gotten dozens of emails from trademark attorneys offering to help me respond to the denial of my trademark request. Is this a conspiracy amongst lawyers to gin up business?

Nuts Reduce Mortality From Lots of Different Diseases

The most recent examination of observational data performed a meta-analysis of 20 prospective studies of nut consumption and risk of cardiovascular disease, total cancer, and all-cause and cause-specific mortality in adult populations published up to July 19, 2016.

It found that for every 28 grams/day increase in nut intake, risk was reduced by:

29% for coronary heart disease

7% for stroke (not significant)

21% for cardiovascular disease

15% for cancer

22% for all-cause mortality

Surprisingly, death from diseases, other than heart disease or cancer, were also significantly reduced:

52% for respiratory disease

35% for neurodenerative disease

75% for infectious disease

74% for kidney disease

The authors concluded:

If the associations are causal, an estimated 4.4 million premature deaths in the America, Europe, Southeast Asia, and Western Pacific would be attributable to a nut intake below 20 grams per day in 2013.

If everybody consumed Dr. P’s Heart Nuts, we could save 4.4 million lives!

Meditativeterraneanly Yours,

-ACP

If you’re curious about why nuts are so healthy, check out this recent meta-analysis, a discussion of possible mechanisms of the health benefits of nuts complete with references:

Nuts are good sources of unsaturated fatty acids, protein, fiber, vitamin E, potassium, magnesium, and phytochemicals. Intervention studies have shown that nut consumption reduces total cholesterol, low-density lipoprotein cholesterol, and the ratio of low- to high-density lipoprotein cholesterol, and ratio of total to high-density lipoprotein cholesterol, apolipoprotein B, and triglyceride levels in a dose–response manner [4, 65]. In addition, studies have shown reduced endothelial dysfunction [8], lipid peroxidation [7], and insulin resistance [6, 66] with a higher intake of nuts. Oxidative damage and insulin resistance are important pathogenic drivers of cancer [67, 68] and a number of specific causes of death [69]. Nuts and seeds and particularly walnuts, pecans, and sunflower seeds have a high antioxidant content [70], and could prevent cancer by reducing oxidative DNA damage [9], cell proliferation [71, 72], inflammation [73, 74], and circulating insulin-like growth factor 1 concentrations [75] and by inducing apoptosis [71], suppressing angiogenesis [76], and altering the gut microbiota [77]. Although nuts are high in total fat, they have been associated with lower weight gain [78, 79, 80] and lower risk of overweight and obesity [79] in observational studies and some randomized controlled trials [80].

The Name For The Nuts Poll: Part Deux

The results of my request for reader input on naming the mixed nuts based on the PREDIMED study I plan to give out to my patients are hot off the presses.

screen-shot-2016-11-02-at-2-50-42-pm

 

 

The winner of the pre-specified names was “Pearson’s Health Nuts.”

Second place went to my personal favorite “Dr. P’s Stroke-bustin’ Nuts.

However, readers submitted some suggestions not in the poll:

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And I had one patient bring in her suggestion with a design already created!:

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and one sketch out her suggestion on what appears to be a post-it note:

img_7959
I’ll term this heart (symbol)NUTZ in the poll

Consequently, I’m soliciting your input into a revised poll that incorporates some of the newer suggestions.

There is much excitement here at mixed nut central because the non-fumigated raw almonds have arrived!

Polldaddily Yours

-ACP

 

 

 

Raw Almonds From The Gas Chamber or: A PPO Most Investors Should Avoid

In my previous post highlighting the marketing hype, silliness, and duplicity surrounding Kind bars, I revealed that the skeptical cardiologist would soon begin issuing bags of special stroke-busting  nuts to his patients.

I solicited a catchy name for the sacks.

One reader suggested:

“The Snack” or “Snack?” No one will forget that name.. In the center of a small heart shape on the front of the package will be shown the type of nuts (either written or better as a picture.. )

Another:

How about “Pearson’s Health Nuts?” It could refer to both the nuts and the eaters.

Another:

“Nuts About Nuts!”

The logo is a kindly cardiologist, in a lab coat, peering over the top of his glasses, with a stethoscope draped around his shoulders.

Another

Call it Pearson’s delight!!! I always keep a bag of nuts mixed with raisins, m&ms, almonds and cashews. Have done this for last 3 years. But some times I over eat them. But better than junk food..hope this is ok

(Raisins and M & Ms are right out! Too much sugar)

I’ve created a poll that I would appreciate your voting on. I can guarantee this will be less controversial than the Presidential election.

Raw Almonds: Straight From Fumigation

While exploring where to obtain the best walnuts, almonds, and hazelnuts for these “yet to be named” snacks, I discovered that the vast majority of almonds consumed in the US have been pasteurized by fumigation with an organic chemical called propylene oxide (PPO).

Because of two salmonella outbreaks involving almonds from California, the FDA mandated in 2007 that all California almonds had to be pasteurized either by a steam process or by PPO. Since the PPO process is cheaper, the vast majority of non-organic almonds have been sprayed with PPO. Both PPO sprayed and steamed almonds are marketed as “raw.”

Although I’m not fanatical about choosing organic (with the exception of dairy) I really don’t like the idea of eating things that have been sprayed with PPO.  PPO is primarily used to make polyurethane plastics. The CDC says:

“propylene oxide is a direct-acting carcinogen”

Several online sources state that PPO has been banned in “Canada, Mexico, and the European Union” including this Almond fact sheet from cornucopia.org

https://www.cornucopia.org/almond/Almond_Fact_Sheet.pdf

but it’s more accurate to say that these countries have not approved PPO fumigation.

Consequently, I’m getting my almonds from nutsinbulk.com. They are selling almonds from Spain, grown organically, and they promise there will be no PPO consumed.

Once my nuts arrive and I get them in appropriate sacks with appropriate labels, I’ll start handing them out to my patients.

If anyone has advice on creating such labels and sacks feel free to comment below.

Amandinely Yours

-ACP

P.S. Here’s what the CDC says about PPO

Studies in animals have demonstrated that propylene oxide is a direct-acting carcinogen. B6C3F1 mice exposed by inhalation to propylene oxide developed hemangiomas and hemangiosarcomas of the nasal mucosa. F344/N rats exposed to propylene oxide in air developed papillary adenomas of the nasal epithelium. Degeneration of the olfactory epithelium and hyperplasia of the respiratory epithelium were induced in the nasal cavities of Wistar rats exposed to propylene oxide by inhalation. Squamous cell carcinomas of the forestomach developed in rats administered propylene oxide by gavage. Although epidemiologic data are not available from workers exposed to propylene oxide, the findings of cancer and other tumors in both rats and mice treated with propylene oxide meet the criteria established in the Occupational Safety and Health Administration Cancer Policy [Title 29 of the Code of Federal Regulations, Section 1990.112] for regarding propylene oxide as a potential occupational carcinogen. The National Institute for Occupational Safety and Health therefore recommends that occupational exposures to propylene oxide be reduced to the lowest feasible concentration.

Choosing A “Healthy” and “Natural” Snack: Kind Bars Versus Simple Stroke-Busting Nuts

The eternal fiancee’ of the skeptical cardiologist (EFOSC) deserves serious kudos for (among myriad other things) challenging his conventional ideas about heart-healthy food and serving as his dietary muse.

However, the EFOSC seems to have a weakness for what I would consider a highly processed, sugared up, over-priced piece of marketing hype—Kind Bars.

I asked the EFOSC recently why she was so enamored of Kind Bars and she told me “I like that they are convenient, you can find them anywhere, they are not expensive and they taste good and they are low in sugar and they are 100 times better than all the other snack bars on the market that are expensive and have tons of sugar and chemicals and disgusting things in them:

She also points out that for frequent business travelers, the bars are more convenient (and often cheaper) than buying  a bag of nuts in an airport kiosk.

She is not alone.

The Booming “Healthy and Natural” Snack Bar Business

The “healthy” snack bar business has been booming lately.

The WSJ points out

“Bar makers are opening the floodgates on nuts, dried meats, cricket flour and other nutrient and protein-rich ingredients to compete for consumers and command top dollar. Many of these ingredients cost more than those found in a traditional cookie—and as sources of protein, ounce for ounce, some of them cost more than a steak.There are 1,012 nutrition bars on the market now, compared with just 226 a decade ago, according to a tally by Valient Market Research in Philadelphia.”

Consumers, attracted by convenience and a desire for “healthy and natural” food are paying more for snacks like Kind bars which have high profit margins.

“The average bar costs about two dollars, up from just one dollar 10 years ago, a sign of how much more consumers are willing to pay, or “diminishing price sensitivity,” as Valient founder Scott Upham calls it. “The cost of ingredients makes up only 25% of the price, and profit margins for bars tend to hover as high as 40% to 50%, compared with only 20% to 30% for most other packaged foods, says Mr. Upham.”

Stores love them because “they are individually wrapped and have a long shelf life, yet they are popular and turn over fast.”

Are Kind Bars And Their Ilk Healthy?

Interestingly, about a year ago, the FDA issued a “warning letter” to Kind asking the company to remove the term “healthy” from its product labels.

Violation 1a. of that letter fingers Kind Fruit & Nut Almond & Apricot for having 3.5 grams of saturated fat per 40 grams of food (the so-called Reference Amount customarily consumed or RACC) which is more than the 1 gram of saturated fat per RACC allowed if is one is going to describe one’s food as healthy.

This is clearly a ridiculous and out-dated requirement: saturated fats are a diverse category of nutrients, some of which are likely very healthy (see my posts on dairy fat or coconut oil). According to these criteria, foods that are clearly very healthy such as avocados, salmon and nuts, cannot be labeled as healthy.

Kind fought back and challenged the FDA and the FDA backed down.

According to the WSJ:

“The FDA said in a statement to The Wall Street Journal that in light of evolving nutrition research and other forthcoming food-labeling rules, “we believe now is an opportune time to re-evaluate regulations concerning nutrient content claims, generally, including the term ‘healthy.’”

However, I don’t think Kind bars are necessarily a healthy good food choice. I think people buy them because they have been slickly marketed as “healthy” and “natural.”

As Marion Nestle points out, when it comes to food labels, “healthy” and “natural” are marketing terms.  Their purpose is to sell food products.

kin-17113-4
Is this the most annoying advertising blather in existence? Is the EFOSC a KINDAHOLIC with an uncontrollable love for KIND and spreading kindness?

The ingredients in the almond and apricot Kind bar are: Almonds, coconut, honeynon GMO glucose, apricots, apple juice, crisp rice, vegetable glycerine, chicory root fiber, soy lecithin, citrus pectin, natural apricot flavor.

Nutrition: 180 calories, 10 g fat (3.5 g saturated fat), 25 mg sodium, 23 g carbs, 3 g fiber, 13 g sugar, 3 g protein

Basically, the healthy part of this Kind Bar is almonds and coconut, which you could purchase for a hell of a lot less than what you are paying for this processed junk.

And why is it necessary to add “apricot flavor” if there are real apricots in it?

Also, note that the third ingredient is honey and the fourth is non GMO glucose. What on earth is non GMO glucose? Do we really care whether the added sugar you are pumping into your crappy bars is GMO or non GMO?

Some Kind bars are clearly no healthier than a typical Payday candy bar:

img_7567
Is a KIND bar any healthier than these Halloween treats? Is that Jenny in the background, Dr. Pearson’s marvelous medical assistant?

IAs Crains  writes:

“the packaging of the dark chocolate cherry cashew bar advertises the word “Antioxidants.” In other words, the bar isn’t promoted as being low in sugar, so it’s a fair choice to compare with a PayDay.
The Kind bar has 9 grams of fat—1 gram less than PayDay’s bar. The sugar count, at 14 grams, is 2 grams less than PayDay. So far, so good. But this particular Kind product has a total carbohydrate count 1 gram higher than PayDay, and 1 fewer grams of protein. The bar has 2.5 grams of dietary fiber, a fraction more than PayDay.”

The Kind PR machine responds thusly:

“It is not at all a fair comparison to equate KIND’s Dark Chocolate Cherry Cashew bar to a Pay Day,” a company spokesman said. “This completely ignores the nutrient-rich ingredients that are in a KIND bar, not to mention the exponentially lower level of sodium.”

You can buy 24 Payday bars at Sam’s Club for $14, about 61 cents a bar.

To be fair to the EFOSC, she usually only eats Kind bars that have about 5 grams of sugar.

Preventing Stroke and Heart Attack with 30g of “Mixed Nuts” Daily

In a previous post (Nuts, Legumes, Drupes and Mortality)  I summarized the evidence IMG_3593supporting the cardiovascular benefits of consuming various kinds of nuts.

The PREDIMED trial, in particular, showed a remarkable benefit in reducing heart attacks and strokes when patients ate a Mediterranean diet supplemented with 30g mixed nuts per day (15g walnuts, 7.5g almonds and 7.5g hazelnuts). Walnuts and almonds are actually drupes, but hazelnuts are true nuts.

The  Mediterranean diet, including nuts, reduced the risk of cardiovascular diseases (myocardial infarction, stroke or cardiovascular death) by 30% and specifically reduced the risk of stroke by 49% when compared to a reference diet consisting of advice on a low-fat diet (American Heart Association guidelines). The Mediterranean diet enriched with extra-virgin olive oil also reduced the risk of cardiovascular diseases by 30%.

You can buy 454 grams of walnuts or hazelnuts for $14 , and 454 grams of almonds for $10. Thus, for 46 cents for the walnuts, 23 cents for the hazelnuts and 16 cents for the almonds (total 85 cents) you can recreate the snack that the Spaniards ate in PREDIMED.

This compares to Kind bars which retail anywhere from $1.99 to $3.50.

The PREDIMED investigators explain why they chose these specific nuts:

“WALNUTS. Walnuts differ from other nuts in that they are very rich in omega 6 and omega 3 type unsaturated fats. Moreover, the antioxidants they contain are among the most powerful in the plant world. It should be mentioned that, like omega 3 in fish, nut fats possess important beneficial properties for general health and the heart in particular.

ALMONDS. Almonds form part of many traditional desserts and sweets of Arabic origin, such as nougat. Currently, Spain is the second largest producer and consumer of almonds in the world, after the United States. As with hazelnuts and olive oil, almonds are rich in oleic acid. They differ from other nuts in that they contain more fibre, vitamin E, calcium and magnesium.

HAZELNUTS. Hazelnuts, another widely consumed nut in Spain, are very rich in oleic acid. Furthermore, they are nuts that provide a large amount of folic acid, a vitamin very important for regulating the metabolism, a lack of which can lead to thrombosis and an acceleration of degenerative processes such as arteriosclerosis and senile dementia.”

Unfortunately, I can eat neither hazelnuts nor walnuts (tree nut allergy), but I’ve decided to create for my patients little baggies filled with 30 grams of the magical PREDIMED nut mixture. I’ll give these out during office visits as I explain the glories of the Mediterranean diet (I’ll try to forbear elaborating to them the difference between drupes and nuts).

I need a catchy name for these bags-“Pearson’s PREDIMED bags” or “Stroke-busting nuts?”

If any reader or patient has a suggestion, please add it to the comments.

If I choose your suggestion, I’ll provide you with 10 bags of nuts and oodles of glory!

Hopefully, once I start creating the nut bags, the EFOSC will begin to eschew the faux healthiness of Kind bars and embrace the natural and unmarketed goodness of drupes and nuts.

Kindly Yours

-ACP

Somes notes:

A drupe is a type of fruit in which an outer fleshy part surrounds a shell (what we sometimes call a pit) with a seed inside.  Some examples of drupes are peaches, plums, and cherries—but walnuts, almonds, and pecans are also drupes. They’re just drupes in which we eat the seed inside the pit instead of the fruit!

In PREDIMED:

“Every 3 months a supply of 1,350-g walnuts (®California Walnut Commission, Sacramento, Cal), 675-g almonds (®Borges SA, Reus, Spain), and 675 g hazelnuts (®La Morella Nuts, Reus, Spain) is provided to each participant assigned to the MeDiet+Nuts group.”