White Coat Underground

CardioFuel—another magic pill

I get a lot of email asking me about various alternative therapies and supplements. A recurring theme on this blog has been the hyperbolic claims of alternative practitioners and supplement makers, and while I can’t answer every email, I can at least address some of them in the blog. Supplements are often marketed using unsupported health claims to which is appended the Quack Miranda Warning, essentially allowing the makers to say that the pill will have such and such a benefit, while simultaneously denying any responsibility for the claim.  Since the FDA isn’t examining these claims, it’s worth while to ask our own questions.

The latest email concerned a product called CardioFuel. Let’s take a closer look at this stuff.

According to the distributor:

CardioFuel is the most profound energy producing supplement on the market today! It does something like no other can: Increase energy at the most basic metabolic level, by increasing ATP (the biochemical energy unit of transfer) production. More ATP means more energy reserves to overcome chronic disease, beat the competition, and handle the everyday stressors of today’s fast paced world!

So to be taken seriously, there should be evidence that this product: 1) increases ATP, 2) increases “energy reserves”, and 3) helps overcome chronic disease and “the competition”.

First, it is not possible to directly measure ATP in a human being under normal clinical conditions, so any claims about this must be an inference from markers of ATP metabolism, or a guess. We’ll see what the literature says about this below.

Second, we need an operational definition of “energy reserves”. Does this mean fat stores? Glycogen stores? These things are measurable to an extent.  Finally, we can do a literature search to see if CardioFuel or an acceptable analog has been tested for its effect on relevant outcomes.

First, what is ATP?  
ATP is adenosine triphosphate, a biological molecule with many functions, among them the transfer of energy.  ATP is produced in several ways, most famously in the Krebs cycle, a complicated biochemical process which premeds are mercilessly forced to memorize.  ATP contains three phosphate bonds, and the third bond contains a great deal of energy, energy that the body uses to fuel many biochemical processes.  Each molecule of ATP contains a d-ribose moiety, a simple sugar upon which the molecule is built.  One of the claims being made by the CardioFuel folks is that if we ingest more d-ribose, we can make more ATP and be more “energetic”.  
First, ATP synthesis, like most biochemical processes, is subject to feedback regulation; ATP production and its byproducts feed back to reduce further ATP production. Second, it is not clear to me that simply providing more of this particular substrate would significantly boost ATP production.  But with my limited knowledge of biochemistry, it seems like an interesting question to investigate.  

CardioFuel claims that its “ATP boosting” properties are  not just from ribose, but also from other molecules such as carnitine and coenzyme Q10.  There is nothing in the published literature that I can find to support these claims. 
From my perspective as a physician, I want to see results.  Regardless of what is posited to happen at the cellular level, I want to see outcomes studies supporting the claims that d-ribose, or preferably CardioFuel itself actually does what is claimed, which the marketer further specifies:
 
I created CardioFuel to help my patients who suffer serious energy-depleting chronic diseases, such as: heart disease (PVD), diabetes, neuromuscular disease, fibromyalgia, lung disease, Chronic Fatigue Syndrome, kidney disease, HIV/AIDS, etc. These diseases deplete ATP, which CardioFuel rapidly replaces, dramatically improving health, vitality, and Quality of Life (QOL).

A PubMed search for “CardioFuel” turned up nothing.  Of the ingredients claimed to boost energy, d-ribose is the one with the most literature—literature which is not favorable.  There are a number of pilot studies looking at d-ribose in exercise.  For example, one study of twelve cyclists found that, “D-ribose supplementation has no impact on anaerobic exercise capacity and metabolic markers after high-intensity cycling exercise.”  A slightly larger study of rowers compared dextrose (d-glucose) with ribose and found that, “…the dextrose group showed significantly more improvement at 8 weeks than the ribose group.”  Another small study found that,” ribose had no effect on performance when taken orally, at the dose suggested by the distributor.”

Since I couldn’t find literature specific to CardioFuel, and my literature search failed to find significant support for claims of the ingredients of CardioFuel, I went to the CardioFuel website for further guidance.  Tellingly, there are no references to studies of CardioFuel itself but only for its purported ingredients. There are some chaotic lists of incomplete references.  For example, for coenzyme Q10, some of the references are listed, some just quoted without citation, and there is little data related to the claims of CardioFuel.  The section on “elite athletes” addresses ribose directly, but not with outcomes studies.  

I can find no support for the claims made by the sellers of CardioFuel.  But under the Dietary Supplement Health and Education Act of 1994 they are allowed to make these claims as long as they use the Quack Miranda Warning.  I couldn’t find such a warning on any page of the website so I guess I must assume that all of the claims made by the company are verifiable.  I can’t seem to verify them myself, but the data must be somewhere.  Right?

Comments

  1. #1 Marc Ullman
    February 10, 2010

    I agree completely with PalMd’s objection to the notion that anyone could market a product with claims that it can cure serious conditions such as energy-depleting chronic diseases, such as: heart disease (PVD), diabetes, neuromuscular disease, fibromyalgia, lung disease, Chronic Fatigue Syndrome, kidney disease, HIV/AIDS, etc.

    However, the notion that these claims have been made legal by DSHEA is wrong. Dietary supplements are only permitted to make claims relating to the structure or function of the body. Under the Federal Food, Drug and Cosmetics Act products claiming that they treat, cure, mitigate or prevent disease are regulated as drugs (and have been since 1938 – nothing in DSHEA changed this). Companies marketing illegal, unapproved new drugs masquerading as supplements are subject to harsh enforcement action including criminal sanctions such as those imposed on the purveyors of a similar fraud in a prosecution in Springfield Missouri on February 8. http://www.ky3.com/news/local/83825797.html

    On January 19, a company selling steroids masquerading as dietary supplements also plead guilty to a criminal violation of the FDCA also for selling unapproved new drugs.
    http://www.nytimes.com/2010/01/21/business/21steroids.html

    Perhaps it is time for concerned physicians like PalMD to stop reflexively blaming a law that they don’t really understand and take the time to register their objections to the sale of these illegal products with their local FDA.

  2. #2 llewelly
    February 10, 2010

    Everything the body does – whether it’s running or walking, dancing or climbing, or even fighting off a cold – requires energy. Even eating requires energy. Now we know that Michael Phelps, the young swimmer who won a ridiculous number of medals in 2008, requires nearly 4.5 times as much energy per day as a normal person. And we know dragsters are faster than street cars in part because they consume energy much faster.

    Therefor it stands to reason that high energy foods or supplements enable the body to perform better. Thus, it is important to prefer foods with the highest possible energy density. Thus, I recommend a diet of pure bacon fat, as much as you can consume. Not only will this provide with enormous amounts of energy (far more than those childish “energy drinks”), it tastes like the food of the gods.

  3. #3 llewelly
    February 10, 2010

    Disclaimer: I hope no one takes the pure bacon fat diet seriously. Consuming more energy than you use contributes to all sorts of problems – heart disease, stroke, diabetes, etc, because it results in obesity. This is why you should never trust the marketeers of foods, drinks, pills, or whatever, which claim to provide “energy” – if those things really did provide energy, they would make you fat – unless you had a lifestyle that required that energy. In addition – in order for your body to process fat safely, you need a sound variety of other foods. I suspect a diet of pure bacon fat would actually make you very sick long before it would make you obese.

  4. #4 Abel Pharmboy
    February 10, 2010

    That’s actually a major offense for the site to be lacking the FDA dietary supplement disclaimer. You’re right, too: it’s missing on every single page.

  5. #5 Kim
    February 11, 2010

    @llewelly: Not only would a diet of pure bacon fat make you sick and bored, it wouldn’t be all that great for performance, either.

  6. #6 PalMD
    February 11, 2010

    Don’t discourage him, Kim. I wanna see him pull it off.

  7. #7 Greg Laden
    February 11, 2010

    if we ingest more d-ribose, we can make more ATP and be more “energetic”.

    It is very fortunate that the way life works on this planet does not involve this particular feedback mechanism!! (for most things.)

    I love the bacon advice, but this is of course one of the great examples of an “Urban Myth” that is true… when you eat fat, the body literally transfer to fat directly to your hips/stomach (wherever you are laying down your fat), without stopping go.

    I recommend instead 100% pure cane sugar ingested with a serving spoon and a side of Gatorde.

  8. #8 leigh
    February 11, 2010

    the “add more reactants, get more products” line works pretty reliably in a test tube, but affairs in cells and organisms are far more complicated. the oversimplification of biochemistry is great if you’ve got a profit margin to reach, not so great if you are looking for results.

  9. #9 The Perky Skeptic
    February 11, 2010

    I am interested in the bacon fat diet and would like to subscribe to your newsletter. ;D

  10. #10 James Sweet
    February 11, 2010

    Can the bacon fat be packaged in pill form?

  11. #11 PalMD
    February 11, 2010

    @Ullman

    Perhaps I misunderstood. I’ve been going by info that I, as a non-lawyer, can find and understand.

    http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm103340

    It may not be possible always to draw a bright line between structure/function and disease claims. You should look at the objective evidence in your labeling to assess whether a claim explicitly or implicitly is a disease claim. For example, a statement may not mention a disease but may refer to identifiable characteristic signs or symptoms of a disease such that the intended use of the product to treat or prevent the disease may be inferred. It is important that you keep in mind two things. First, the context of the statement, decided from information on the label and in other labeling, will determine if the statement is considered to be a disease claim. Second, dietary supplements may not bear disease claims, explicit or implied, unless the claim has undergone premarket review by FDA and has been authorized or approved under the rules for health claims or drugs, as appropriate. To assist you in deciding whether a claim is or isn’t a disease claim, the new regulation contains a definition for disease, and then includes 10 criteria intended to help clarify the types of claims that may be made for dietary supplements without prior authorization or approval by FDA. We are providing that disease definition and an explanation of the 10 criteria below…

    Since CardioFuel makes specific disease claims, and is marketed as a supplement, this would seem to be “a bad thing”, but once again, IANAL.

  12. #12 Marc Ullman
    February 11, 2010

    @PalMD

    They may be marketed as “dietary supplements” but they are illegal, unapproved new drugs. I totally agree that this kind of marketing is a bad thing, and don’t think I suggested otherwise.

    My point is, and remains, this has nothing to do with DSHEA. FDA can shut these people down if it is of a mind to. They could even go to jail for this.

  13. #13 PalMD
    February 11, 2010

    But if they were to have the standard disclaimer on the page, would that make a difference?

  14. #14 Marc Ullman
    February 11, 2010

    The “structure function disclaimer” is mandatory for use with all legal claims on dietary supplement labels and labeling.

    Failure to use the disclaimer can render an otherwise legal label/advertisement in technical violation. However, it does not provide immunity for otherwise illegal claims.

  15. #15 gaiainc
    February 11, 2010

    Personally, I think that a duck fat diet would be a much better idea than the bacon fat diet. According to Alton Brown, duck fat is liquid love and I have a hard time disagreeing. So good… so yummmy…

  16. #16 ponderingfool
    February 11, 2010

    the third bond contains a great deal of energy, energy that the body uses to fuel many biochemical processes.
    ***************************
    Not so much the bond itself. Breaking the bond “costs” energy. The products formed (ADP & Pi) and their interaction with the solvent are the reason for the net energy released.

  17. #17 Arnold T Pants
    February 11, 2010

    1. I eat bacon fat to help me beat the competition.
    2. Has CardioFuel sued Pal yet?

  18. #18 daedalus2u
    February 12, 2010

    ATP is probably the best regulated molecule in your body, better regulated than nitric oxide even (and that is saying a lot). It is simply nonsense to think that you can change the regulation of something like ATP (which is made and regulated in each different cell according to that individual cell’s individual needs) by changing your diet. Complete nonsense, cells evolved to regulate ATP billions of years ago. ATP was probably the first thing that regulation evolved to control.

    There are 3 ATP parameters that are important, concentration, production rate and consumption rate. The production and consumption are equal because the concentration doesn’t change very much. Over the course of a day, your body makes about 100 pounds of ATP. Each molecule of glucose that is fully oxidized produces 38 molecules of ATP.

    Physiology uses the ATP concentration to regulate stuff. When you feel like you have the most energy actually occurs when you have a low ATP concentration. Muscle can consume ATP down to very low levels, at levels that kill muscle cells. The reason physiology has evolved this way is because when you don’t have enough ATP, the most important thing to be able to do is run away from a predator. If an organism can’t do that, it can’t survive. That is why muscle can work itself to death.

    To produce ATP at the maximum rate, the ATP concentration needs to be low. Low ATP stimulates mitochondria to produce ATP at their maximum rate. Low ATP also turns off non-essential systems. That is known as ischemic preconditioning. In the short term, lots of stuff can be turned off, to give you a few more molecules of ATP, protein synthesis, disposal of damaged proteins, healing, etc. None of those things are non-essential in the long term. Turning them off long term leads to degeneration.

    What actually regulates the ATP levels in cells is nitric oxide. NO is diffusible between cells, so whole tissue compartments operate “in sync”. Oxidative stress causes low NO, that is necessary to disinhibit cytochrome c oxidase to reduce O2 at a high rate. Low NO also causes low ATP (via sGC) and triggers ischemic preconditioning. It takes high NO to turn off ischemic preconditioning. If you don’t turn off ischemic preconditioning, then you are SOL.

    One of the major fats in lard (28%) is tripalmitin, which is a C-16 saturated lipid. When it is fully oxidized it produces 409 molecules of ATP. It melts at 66 C. Another is tristearin (12%), C-18 melts at 72 C. The most abundant is triolein (47%), it melts at -4 C. Some of the lipids are transesterified, that is they have different fatty acids attached to the glycerin. Keeping them liquid at body temperature is important. Lard melts at about 30 C. That is why cold blooded organisms have body fat that is more unsaturated, unsaturated fats have lower melting points. Plant oils have really low melting points, and often it is the freezing of the lipids that is what kills them from cold stress.

  19. #19 Egaeus
    February 12, 2010

    Butbutbut…Dr. Oz was just saying today that d-ribose gave you energy, and he’s a doctor!