You put something in your mouth and swallow it with the goal of treating a disease. Is it medicine? Or is it food?
Well, if you are using food as medicine, then it can be both. The concept of “food as medicine” doesn’t refer to food that may simply taste like medicine—such as that fruitcake that your friend “gifted” you during the December Holidays. Instead, it’s about food items that may help treat different diseases. A 2021 publication in the Journal of Future Foods defined medical foods as “foods formulated and consumed enterally under medical supervision of physicians and intended for the dietary management of a disease or condition.” The word “enterally” here means that it goes through your intestines, which is where food would end up if you put it in your mouth versus somewhere else like your ear.
As you can see, this definition of medical foods also included the phrases “under medical supervision” and “for the dietary management of a disease or condition.” This makes a medical food different from an enriched or fortified food item, which is when vitamins, minerals, or other stuff that may be beneficial to your health are added to conventional foods. It also makes a medical food different from a nutraceutical, functional food, dietary supplement or anything else designated more for general health rather than for treating specific diseases.
Instead, a medical food is more similar to—but not the same as—medications that are manufactured by pharmaceutical companies. Unlike pharmaceutical drugs, though, a medical food must be entirely comprised of regular food ingredients, you know the stuff that you might normally eat for meals, snacks, dates or Groundhog’s Day celebrations.
This could make medical foods an attractive option for those worried about what synthesized stuff may be in a given pharmaceutical medication and the resulting side effects. As Thomas Weimbs, PhD, a Professor of Molecular, Cellular, and Developmental Biology at the University of California, Santa Barbara, and Chief Scientific Officer for Santa Barbara Nutrients, explained, “Medical foods consist of substances ‘generally recognized as safe’ or GRAS by the United States Food and Drug Administration.” So, what’s designated a medical foods should not have to go through as extensive regulatory processes as drugs do.
Moreover, identifying new medical foods could significantly expand the range of available treatment options for patients. Having more treatment options is typically better. It’s especially important for those with diseases that haven’t been the focus of pharmaceutical companies such as conditions that are less common and less understood by political and business leaders.
It shouldn’t be too surprising that food can serve as medicine. As you probably realize, what you eat can significantly affect your health in both negative and positive ways. This is one of the reasons why that all-bonbon diet is not advisable. In fact, special diets have already long been the mainstay treatments for certain diseases. For example, the primary treatment for phenylketonuria (PKU) is limiting the intake of foods that contain an amino acid called phenylalanine such as meat, dairy, nuts and tofu. That’s because those born with PKU have inherited a gene mutation that prevents an enzyme called phenylalanine hydroxylase (PAH) from converting phenylalanine into stuff that your body can use. As a result, phenylalanine can accumulate to toxic levels, leading to brain damage and other problems.
There are a number of medical foods already on the market such as Lipisorb for AIDS patients with fat malabsorption, Nepro for the nutritional needs of those on dialysis, Oxepa for those with lung injury, Renax for those with end stage renal disease, and Ultrase for those with pancreatic insufficiency. So, here’s some food for thought: are these products just scratching the surface? In other words, how much is food being left on the table when it comes to finding more ways to use food as medicine? Are the right mechanisms really in place to encourage more research in this area and have more such products to reach the market?
Well, Weimbs entered the medical food space inadvertently only after an accidental finding. For years, his research had focused on the mechanisms behind polycystic kidney disease (PKD). PKD is when multiple round, fluid-filled cysts of different sizes develop in your kidneys and grow to the point that they cause damage to and impair the functioning of your kidneys. Over time, this can result in high blood pressure, kidney failure and all sorts of life-threatening problems. Most often, PKD is inherited, although there are non-inherited forms of PKD as well.
One day Weimbs encountered what could be termed a “mice” surprise. A member of his laboratory tried putting mice with PKD on a calorie-restricted diet in order to inhibit a cell-signaling pathway called mammalian target of rapamycin (mTOR). He then found an unexpected effect: the PKD didn’t progress. This led to further experiments showing how diets that can induce ketosis could slow the growth of kidney cysts in PKD in rodents, as described in publication in Cell Metabolism. Ketosis is when you body burns fat rather than glucose to get energy. The breakdown of fat results in compounds called ketones, hence the name ketosis. Ketosis can result when you starve yourself or consume a diet that is very low in carbohydrates resulting in dearth of sugar in the bloodstream to burn.
Weimbs team found that subjecting rats with PKD to intermittent fasting led to lower blood blood glucose levels and ketosis, resulting in increased levels of β-hydroxybutyrate (BHB). These rats ended up having smaller cysts and improved kidney function. Such findings prompted Weimbs to explore using BHB to treat PKD, which ultimately resulted in a product called KetoCitra that’s being produced by Santa Barbara Nutrients. The Santa Barbara Nutrients website describes KetoCitra as “the FIRST non-prescription product specifically designed for the dietary management of chronic kidney disease (including the genetic form polycystic kidney disease).”
As Weimbs indicated, “KetoCitra contains two main ingredients, BHB and citric acid. BHB is a potent signaling molecule, a potent anti-inflammatory. Citric acid is part of the kidney’s normal defense against kidney stones. ” Even though you probably don’t usually ask the server at a restaurant, “What are your citric acid specials today,” citric acid does occur naturally in numerous foods, especially citrus fruits—hence the name—with lemons and limes having particularly high concentrations. “Medical foods are much less expensive to put together,” Weimbs related. “You don’t have to do the same kind of clinical trials that are required for drugs. As a result, it’s less expensive to get a medical food to market than a drug to market, which can cost around $1.5 billion. The cost for a medical food can be about a hundred times less.”
With clinical trial costs being so high, pharmaceutical companies may be reluctant to develop drugs for conditions that don’t seem to have a big, guaranteed financial return. This can leave in the lurch patients who have conditions that don’t get that much attention. Ask the typical American about PKD and they may think that you are referring to someone’s initials or Pi Kappa Delta. When Glenn Frommer, the CEO and Founder of Milkbox Partners, was diagnosed with PKD a decade ago, he had never heard of the condition before. He was also told, “that there was nothing I could do about it. That it was only a matter of time before I would require dialysis and be on the kidney transplant list.” He would not accept this and began “looking for every potential avenue,” in his words.
Frommer started getting involved with different foundation and groups including the PKD Foundation and connected with different doctors, nutritionists and dieticians to find ways to better manage his condition. He eventually became a vegetarian and altered his diet in different ways. During a four-month period over the Summer of 2022, he rode his bicycle from San Francisco, California to Cape Cod, Massachusetts, in an effort to raise PKD awareness and funds for the PKD Foundation and PKD research. This included stopping by at different universities where scientists were conducting such research. In the process, he met Weimbs.
So how is Frommer now, years after he was told that there was nothing he could do? Well, if Frommer’s cross-country ride is any indication, he’s remained very active and managed to defy the more dire prognoses that he initially received. Frommer credited what he described as taking a more “proactive approach to treatment of disease.”
Expanding the use of “food as medicine” seems like a no-brainer. But there are still a lot obstacles baked-in to our country’s current health systems. Weimbs pointed to the lack of support for research into potential medical foods: “Often funding agencies are very focused on pharmaceutical approaches. 90% of clinical trials funded by pharma.” Even after medical foods reach the market, “they may not be reimbursed by health insurance,” Weimbs added. “Many doctors are not familiar with medical foods. They are often hesitant, because medical foods are not FDA approved [in the same way that drugs are].”
Moreover, as Timothy Morck, PhD—Founder and President of Spectrum Nutrition a consulting firm for nutrition-related regulatory policy and scientific affairs—noted, the way FDA is regulating medical foods seems outdated and unclear. He elaborated, “Nothing has been formally updated, despite major advances in nutritional science and understanding of physiological processes in the body, healthy or disease-impacted. It is unfathomable to believe that regulatory language governing this important class of food products has not been changed or updated, in 36 years!!!” Morck continued by saying, “But, the FDA still uses the same claim that they have other priorities and insufficient staff.”
Therefore, those interested in medical foods can’t simply rely on word of mouth to find more treatments besides pharmaceutical drugs to put in their mouths. There needs to be significant changes in the systems that govern healthcare such as overhauling how doctors are trained, how insurance reimbursement works and what gets supported by funding agencies and policy makers. Otherwise, those hungering for better ways to manage their medical conditions may not realize that the solution could already be embedded what’s already being eaten.
