More Trials to Come
These results represent a significant milestone for the Weimbs Lab, which has for more than two decades been researching the cell mechanisms that underlie PKD and other renal diseases. A chance discovery made by researchers in the lab — kidney cysts had dramatically shrunk in mouse models that had undergone caloric restriction — led them to pursue the idea that the fasting response known as ketosis might have some impact on the growth of the apparently glucose-dependent cysts.
However as any scientist knows, one needs solid evidence to back up any claims of medical benefit for humans. You need clinical trials.
“If you make a discovery in animals, but you don’t check it in actual people, you’ll never quite know if it’s going to be meaningful,” Weimbs said. “There’s always going to be the doubt, and people are going to say animal experiments don’t always translate to humans.” Money to fund these trials became a challenge, thanks to the prevailing notion that PKD was unrelenting because of its genetic origin.
“And, of course, it’s always hard to find funding for diet interventions, because nobody wants to fund diets; they want to fund drug research,” Weimbs added. Drug companies, which fund most clinical trials, have no interest in a diet, he added.
However, Weimbs, together with Dr. Müller, was able to garner additional funding from the PKD Foundation to conduct the clinical trial in Germany.
“Dr. Müller was able to supplement this with some other funding he had, and we essentially designed this trial together based on the animal results,” Weimbs said. “But really the entire trial was run by his team, so they deserve all the credit and they did a fantastic job. They did everything despite the challenges of COVID.”
With these results, Weimbs and his team are looking ahead to further clinical trials slated to start in the coming year, one in Toronto and the other in Tokyo, to assess the efficacy of a medical food they developed specifically to assist PKD patients in reaching ketosis. Called KetoCitra and available through the Weimbs Lab’s spinoff company Santa Barbara Nutrients, it’s a formulation of the ketone beta-hydroxy-butyrate (BHB) that is generated during fasting, without the other ingredients and fillers that may be present in drugstore versions of BHB. The studies will involve more people — 80 in Toronto and 200 in Tokyo — and follow patients for a year. These trials will investigate the efficacy of the Ren.Nu plant-focused ketogenic diet in conjunction with KetoCitra.
“We want to investigate the longer-term effects,” Weimbs said. “If this trend of kidney volume change we saw in the three-month study holds true, we would expect to see a larger and statistically significant difference there as well.”
Source: bing.com