Dr. James Kelley, MD - Utilizing the Fasting Mimicking Diet

Dr. James Kelley, MD
Consulting Medical Science Liaison, L-Nutra

James brings both clinical and business experience to L-Nutra. His background is in the development of early stage medical and biotechnology, in addition to working with and educating physicians, nurses and other healthcare professionals.

James completed his M.D. at The Ohio State University, and was the inaugural Research Fellow at the Ohio Health Research and Innovation Institute. He finished his MBA at the University of Southern California Marshall School of Business. He has worked with the USC Alfred Mann Institute for Biomedical Engineering, the Lloyd Grief Center for Entrepreneurial Studies, and the Stevens Institute of Technology. He holds a Bachelor’s degree in Cell Biology from the University of Virginia, and completed his Neuroscience Masters coursework at Miami University.

Prior to joining the L-Nutra team, he was the head of Inventor Services at The Innovation Institute, a partnership with the Cleveland Clinic Innovations group focused on developing and commercializing new and innovative healthcare solutions.

TRANSCRIPT

Dr. Pompa:
Welcome, Dr. Jim. I appreciate you taking time for this interview.

Dr. Kelley:
Thanks for having me. I’m really excited to join you.

Dr. Pompa:
Yeah. Well this is one of my favorite topics, fasting in any capacity. Anyone watching this I’m sure knows that this is one of my favorite topics in the world. I’ll tell you what, fasting mimicking diet is taking the nation, the world, by storm. For our viewers who have never heard what the heck a fasting mimicking diet is, perhaps you should explain that. You’re one of the leading doctors in this and have been for a while, so maybe you start with explaining how you got involved in this, but what the heck is a fasting mimicking diet anyway?

Dr. Kelley:
Yeah. Those are all great questions. Just by way of background, I’m an MD-MBA, I did a lot of work in [inaudible 00:00:49] funding, patenting, research and launching bringing new medical stuff to market. I spent a couple years at the Cleveland Clinic Innovations Group, but while I was completing my MBA at the University of Southern California, I had the pleasure of meeting Dr. Longo, Dr. Valter Longo, the founder of the fasting mimicking diet, and at the time was working with him to help write the business plan for longevity centers. Then I went about my way, launched a couple medical companies, learned a lot more about sports medicine and nutrition, and then a couple years later got approached by Dr. Longo to come on board and help launch the company, which is now L-Nutra, the founders of the prolonged fasting mimicking diet. I’ve since transitioned into the medical science liaison role, but I’ve been here since the launch.

Basically what it is, the reason I felt so compelled to leave the Cleveland Clinic Innovations Group and come join this is specifically because of what I see us doing in our preclinical research and now in the general wellness sector around really improving lives.

What fasting mimicking diets are and what fasting is in general as I’m sure many of you are already familiar, you’ve probably heard of intermittent fasting, well, it turns out if you do a prolonged fast, and we’ll go into much greater depth when we talk at the seminar, but essentially the concept is you take a couple days away from food, you turn off the body’s nutrient sensing pathways. If you turn off those pathways, you turn on the cellular cleanup pathways, specifically autophagy and apoptosis. Those are cellular cleanup through both repair and replacing damaged tissue with brand new stem cells. The concept of it is basically if you take enough days away, you start the process. You take a couple more days away, you clean it all up and you boost your circulating stem cells. That’s the theory that seems to be proven in animal models and we’re gathering data in humans and some of our clinical trials have already demonstrated that. We’re very excited that over five days you can essentially sort of push a reset button on the body.

But the really interesting part is what Dr. Longo figured out is that these pathways that sense nutrition are not on, off switches. There’s a certain amount of food that I can still give you if it’s the exact perfect ratio and this is what we’ve spent at this point almost 40 million dollars of federally funded NIH and NCI research money figuring out what those ratios are where I can give you actual food and still be below the threshold that allows you to turn on those cleanup mechanisms, so I can mimic that fast without actually having to fast so I can make it both easier and I help protect lean body mass and a number of other benefits. But again, we’ll go into much greater depth on how it works and why it works and probably how we all evolve for this and how it really does impact basically every cell in the body.

Dr. Pompa:
Yeah, no doubt. I can tell you clinically we have doctors all around the country doing this and I’ll tell you, it’s something that is pretty remarkable to watch and I believe every human needs to go through these times of no food, lack of food like you’re saying. I believe we’re genetically programmed for it. I think you’re seeing in some of the studies. What’s your thoughts on that? Is this something that humans are missing now and now we’re putting this together and here we’re getting results?

Dr. Kelley:
This really is … that’s a great point. It really is sort of looking to the past to discover our future. If you look at, and again, we’ll go into much greater depth later on, because there’s quite a bit of biochemistry and this is what the fascinating research is all showing, but if you look at all the way up from yeast to humans the only way we made it this far was being able to survive between meal A and meal B. So that heavy, heavy, heavy evolutionary pressure to develop some mechanism to not just survive but also optimize when you run out of food so you can go both get to the food and survive but also beat your neighbor there, which will allow you to pass on your DNA so there’s a huge pressure to develop this mechanism. We absolutely did.

Every cell in the body has that mechanism where when resources are scarce, everything gets better, everything optimizes, for the short period of time. If you go longer than a certain amount of time you start to get into the danger zone, but it very much seems that all of our ancestors were correct, all of the major religions incorporate some sort of fasting. The concept of it is rock solid and at this point the research is backing it up to a level where I don’t think you can dispute it. You can’t really dismiss it as a fad anymore. There’s so much evidence that it’s beneficial, not just in healthy people but in potentially, and this is what we’re now exploring, is disease states. Obviously we’re a ways away from making any claims, but we’re very excited about where that’s headed.

Dr. Pompa:
I’ll have you talk about some of the studies, and that’s all you can state is here’s what we’ve found type thing, but I can tell you years ago, gosh, I don’t even remember how many years ago it was now, and there was a gentleman from France, [inaudible 00:05:46] I don’t know how to pronounce his name, if you had French I can’t pronounce it. Italian, I’m okay. Anyway, I found his stuff, and he was basically calling it a partial fast back in the day and basically very similar to the fasting mimicking diet, and found that some people responded better. It was definitely easier and some people, like I said, just depending on their condition, really it was just a better response.

I can tell you this, what you all did by putting this partial calorie low protein, because too high a protein, you break out of this autophagy state you’re describing, this clean up state.

Dr. Kelley:
Yeah, too much insulin or too much protein, yeah.

Dr. Pompa:
Yeah. Too much calories or too much protein or too many carbs even. But you said it, there’s these perfect proportions. But you guys put it in boxes, which was absolutely brilliant, because let me tell you something. Although for years I utilized as a tool partial fasting, it was harder for people than regular fasting and here’s why, because they would start with doing food and they couldn’t stop. But what we found was because they had the box of food, it’s like, this is what I have to eat today. It was a breakthrough because it was easier for people. Even me, because I said I find partial fasting hard because I get in my kitchen, I start doing food, I start not knowing when to stop and it becomes more difficult.

But when I have this box of food, it’s that simple. Five days, five boxes of food. It was brilliant.

Dr. Kelley:
Yeah, that’s exactly what Dr. Longo’s goal was is give you a precise and convenient way to do this. The only reason that the company exists, he didn’t set out as a researcher to create a product, he set out to solve a problem. When he was doing his research he was seeing everybody was dropping out of the pure fast by day two because it was just too difficult and if people tried to make this on their own, like you pointed out, they have trouble getting the ratios right, but beyond that, they just have trouble with the discipline. [crosstalk 00:07:42] essentially of carefully disciplined behavioral modification tool. We’re keeping you busy, we’re telling you exactly how to do it. You can vary it during each day, you just can’t bring anything from day one to day two and day two to day three, etc.

We did the thinking for you. We think it’s really good food. It meats all the ratios of all of our clinical trials. We’re trying to make it as clean as possible. We’re always refining it, but we think we have a great product. So far, we’re seeing really promising results from a general wellness standpoint, a lot of good people sending us a lot of interesting emails. I get a lot of good feedback about what it’s doing to people.

Dr. Pompa:
My team is gonna kill me here. You might kill me. At the seminar, one of the fun things we do at the seminar is we actually … and you’re speaking at the seminar, which is gonna be awesome.

Dr. Kelley:
Very excited about it, yeah.

Dr. Pompa:
You’ll go into depth in a lot of this new studies. By the way, you all just got 44 million dollars plus from the NIH?

Dr. Kelley:
We’re raking it in to … that’s all because they’ve been seeing what the benefits of … because if you think about it again, what we’re doing, the father of medicine, Hippocrates, said, “Let medicine be thy food and food be thy medicine,” and then some time in the 1900s and 2000s we said, “Nope. We’re gonna give you a pill.” Now what we’re doing is saying, “Well, the body was not designed for one pathway to be blocked by one molecule. It’s this whole system that’s carefully orchestrated so we just figured out how to get the right conductor in there.” We’re very excited about that.

Dr. Pompa:
What you should do as a company, right, at my seminar. The answer might be no, but we intermittent fast before, we fast people during the day and we’re teaching them how to look at their blood ketones, etc, and glucose, and then we do a little meal partway through the day. It should be the box of food. You guys should donate a box of the food so people try it.

Dr. Kelley:
I’ll see what I can do.

Dr. Pompa:
All right.

Dr. Kelley:
That is actually the biggest hangup people have. The big concern is they don’t think they’re gonna be able to do it.

Dr. Pompa:
That’s right.

Dr. Kelley:
Even though we give you quite a bit of food, people are concerned it’s just not gonna taste good enough, they aren’t gonna be able to do it, so once they see that this is really good nutritious, well composed food with good flavors and some variety and they know they’re gonna be able to get through the five days, it gets much easier.

Dr. Pompa:
I heard … Listen, I haven’t even had your new bar yet. My kids loved your old bar.

Dr. Kelley:
I think this one’s better and we’re coming out with a couple new flavors over the next coming months. I’m hoping-

Dr. Pompa:
We’re gonna be able to sample those at the seminar?

Dr. Kelley:
I’ll bring you some samples so everybody can indulge.

Dr. Pompa:
Anyways, yeah. We’re putting you on the spot here. I’m excited. I really am. We’ve been teaming up with you all because we believe so strongly, obviously, in fasting but we believe strongly in the ProLon product. We really do. It makes everything easier and the power of the fasting mimicking diet and it really is amazing. Look, there’s many people who water fasting, which I used for years, but it’s too hard. This is safer for metabolic people, for people who are on different medications. There’s many reasons why this has been a godsend for [inaudible 00:10:40]. We’re gonna learn about more of it, but can you … talk a little bit about some of the exciting studies that you’ve done and are doing.

Dr. Kelley:
Sure. [inaudible 00:10:54] obviously a bit careful because none of this has been evaluated by the FDA to diagnose, treat, cure, or prevent any disease, but we do have some really interesting preclinical results in animal models around disease states and the future of this will, and we’re doing human trials in a lot of different states, such as neurodegenerative, we’re looking at Alzheimer’s, Parkinson’s, multiple sclerosis and the impact of fasting, because in our animal trials we demonstrated that you can halt MS progression in animal models of MS. In 85% of mice, you can actually reverse it and in some cases cure it in about 18%. Really exciting results. That’s part of why the government gave us enough money to look at it in humans. I hope I’m not speaking out of turn, but I believe that’s published, that’s open information.

We’re also looking at other trials including some autoimmune conditions, mostly around dietary, ulcerative colitis, Crohn’s, and we’re going to be looking at obviously rheumatoid and lupus. We think there’s a lot of promise around a number of other conditions. Some of the ones I think we may have a big impact in are still being evaluated for whether we can … how we would do those trials, but basically since every cell in the body responds to fasting, every cell in the body is fair game to look at for a lab test and a clinical trial.

Dr. Pompa:
Yeah.

Dr. Kelley:
Very, very exciting preclinical results and in humans we’re starting to get the ball rolling in some of the more important stuff. We’re looking at cancer. Right now, I think we’re about a year away from publishing a really, really interesting paper on fasting in combination with chemotherapy and fasting mimicking diets and showing what it can do for people.

Dr. Pompa:
You know again, I was out at the US fasting summit you all did, USC, I’m sorry, USC Fasting Summit. There was … one scientist after another showing results of their studies with cancer. Just exciting stuff. Again, these are studies. You know, obviously they made it clear what they’re doing in animals and what they’re not only doing in humans.

Dr. Kelley:
And it’s a different product than ProLon [crosstalk 00:12:48].

Dr. Pompa:
It was, it was. It was totally and to be clear, but the principle is solid here. I read … I filed a study and I think I put it in my book. It was on that humans right now are in a constant feast state and to go back to the point we made earlier, we’re not forced to have these times of famine. That’s a mistake, and in this particular study they talked about how they believe that because we are in this constant feast state that it’s leading to problems like cancer.

I think you’re right. They’re … it’s programmed in our DNA and I think a lot of the results is because we’re doing something that we should genetically be doing.

Dr. Kelley:
That’s my philosophy for certain. Yeah. I think variety is the spice of life, it may also be the source of life. I do think that changing of the metabolic guard and letting your body get a variety of states that it was designed to deal with, that’s … visceral fat is your safety net for times of lean and we’re burning through it. We’re getting the body to use it up.

Dr. Pompa:
Absolutely.

Dr. Kelley:
Then in some cases if you’re at your ideal weight, it will replenish it fairly quickly, but that just makes sense. The body wants to refuel the emergency tank. A lot of really interesting stuff. I totally agree with your philosophy. I’m excited to talk to everybody about it and share all the nuances of what we know and what we don’t know.

Dr. Pompa:
We just interviewed Dominic D’Agostino who is doing research with the Defense Department and he was talking about these times of famine and it’s really a time when you get the ketones much higher. Going in, again, he was talking about research that he’s doing on what ketones do for the brain.

Dr. Kelley:
Yeah, beta-hydroxybutyrate, yeah.

Dr. Pompa:
Right. People have to understand it’s very hard oftentimes to hit the therapeutic levels of ketones without doing some type of massive caloric restriction feast or famine states and that was to his point as well. You know, I think an exciting thing for me is the anti-aging topic and I know that we brought up Dr. Valter Longo, who is doing a lot of these studies. He backed into this because I think it was one … and you can tell this story better than I, but his predecessor he was in the Biosphere 2 project. It was basically, okay, all these studies are showing caloric restriction is the key to anti-aging, but yet clinically I can tell you that it doesn’t work. If you’re in a caloric restricted state too long, the body goes into starvation mode and bad things start to happen. That’s kind of what happened in the Biosphere 2 project. It was a fail, but from that, I believe Longo started saying, “Well, what if we did shorter periods of time.”

Dr. Kelley:
Yeah.

Dr. Pompa:
Tell that story, because this really reflects that.

Dr. Kelley:
I’ll save that for the … I gotta … we’ll save that one. You did an excellent teaser so we’ll save that for the whole thing.

Dr. Pompa:
But this is the key to anti-aging in my opinion.

Dr. Kelley:
I’ll tell you, to me the breakthrough was the Laron population in Ecuador. The group with the IGF-1 mutation that doesn’t respond to protein. They never have … they’re about three feet tall so they don’t respond to growth hormones, or they don’t activate growth hormone because protein doesn’t trigger it, but they also have never gotten any cancer or diabetes. These are two age related diseases so we now know that height and growth are related to age and aging, so IGF-1 is a trigger for that pathway.

That’s sort of a little bit of an a-ha of okay, well if IGF-1 is a trigger, can I get some of the benefits of anti-aging by calorically restricting for a very short period of time and a very specific window of caloric restriction and give you all the [inaudible 00:16:21] benefits that are allowing these people to live long, healthy lives without restricting the growth? That’s something we’re doing a lot of research on. The theories look sound and the preclinical research is promising. Mice live about 15% longer, they get less cancer, less heart disease, less autoimmune disease, less diabetes, regenerate nerve tissue. Their immune system appears to function stronger. Now we just have to recreate in humans, because obviously we are not just big mice. We are more complex organisms and our life cycles are longer and more things play into it, so … but I do think fasting is absolutely a huge part of the puzzle and I think we’re making headway into proving it.

Dr. Pompa:
No doubt about it. I appreciate you guys and love all of you and glad to be on your team, I’ll tell you that much.

Dr. Kelley:
We’re glad to have you.

Dr. Pompa:
Yeah, no doubt. Listen, y’all need to be at the seminar [inaudible 00:17:05] rest of the story. But no kidding, you’re going to learn a lot. I have to say this, share this with not just your doctor friends but your friends and family because this is the first time I think we actually have a whole day that the public’s allowed into the seminar so you’ll get to hear this cutting edge new information, man. Dr. James. You’re a wealth of knowledge man, I appreciate it.

Dr. Kelley:
Thanks for having me. I’m looking forward to speaking with all you guys in person. Come on down.

Dr. Pompa:
Yeah. Y’all can get the … you can look at the dates of the seminar right here on this page and also you can sign up for the seminar right here on this page. Do that because you’re not gonna want to miss this. We have so many incredible practitioners and doctors, scientists all here so you need to hear it. Thank you, man. Appreciate you and thanks for being on the team. We’ll see you there.

Dr. Kelley:
Thanks for having me. I’m looking forward to meeting all you guys in person. All right.

Dr. Pompa:
Absolutely.

Dr. Kelley:
Bye.