How Thorne Uses Clinical Trials to Make Products

Dr. Amanda Frick:

This is The Thorne Podcast, the show that navigates the complex world of wellness and explores the latest science behind diet, supplements, and lifestyle approaches to good health. I'm Dr. Amanda Frick, the Vice President of Medical Affairs at Thorne and a naturopathic doctor. As a reminder, the recommendations made in this podcast are the recommendations of the individuals who express them and not the recommendations of Thorne. Statements in this podcast have not been evaluated by the Food and Drug Administration. Any products mentioned are not intended to diagnose, treat, cure, or prevent any disease.

Dr. Amanda Frick:

Hi everyone, and welcome to The Thorne Podcast. Thanks for giving us a listen. And if you like what you hear, tell a friend about the show. Joining me once again is Dr. Jennifer Greer, the Director of Medical Education in Thorne's department of Medical Affairs. How are you doing this week, Dr. Greer?

Dr. Jennifer Greer:

I'm doing great this week, thank you. It looks like a beautiful day outside. I'm excited to get out a little later and get some exercise in. How about you?

Dr. Amanda Frick:

I'm doing really, really well. I'm excited. I've started a new book. I've said before, I'm not telling people what I'm reading, but I like it anyway.

Dr. Jennifer Greer:

A new book is always exciting. I love a new book.

Dr. Amanda Frick:

Yeah, it's so weird. It's like moving from one planet to another when you switch book series. I've been reading the same series for a year, and so moving into something new has been a massive struggle, but I'm trying really hard and finally getting there.

Dr. Jennifer Greer:

Very exciting. That moment when you get sucked in and you're fully into it is when you know it's good.

Dr. Amanda Frick:

Yeah, I like a good fiction book. I'm going to do a cheesy little segue here, like “speaking of fiction”… There is so much information out there about health and health and wellness trends and things to do, things not to do. It can be really hard to separate fact from fiction when we're talking about some wellness trends. Is there a health myth or a misconception you've come across that you think needs to be busted and you should just bust it right now?

Dr. Jennifer Greer:

I do have one of these. This one came up recently. I feel like we get asked this question quite frequently. And there seems to be some misconception around it, so I don't know if it's maybe something that's circling on social media that's just not quite accurate or what. But what I want to talk about is vitamin D and vitamin K and why those two things are sometimes recommended to be taken together.

So there seems to be a misconception that vitamin K would affect the absorption of vitamin D. And I want to bust that myth because you don't take them together to affect the absorption of each other, it's because they both affect how your body uses calcium, and they do that in different ways. So vitamin D helps our bodies absorb calcium, and it also helps to change the amount of calcium that's available in the blood based on what our body needs. Whereas vitamin K helps to take calcium from the blood and move it into the bone and keep it out of soft tissue. So often, particularly when we're talking about bone health, people will be recommended to take vitamin D and vitamin K together, and it's because of their relationship to calcium more so than their relationship directly to each other.

Dr. Amanda Frick:

So these evil vitamin D-only supplements on the market are not so evil.

Dr. Jennifer Greer:

Exactly. They are not so evil after all. They have a purpose too.

Dr. Amanda Frick:

Just because we're speaking of vitamin D and talking about it, I mean there are some things that are important about what to choose when you pick your vitamin D supplement, right? Could you just touch on that?

Dr. Jennifer Greer:

Yeah, absolutely. So vitamin D specifically, I think there are a couple of things. One is knowing that you're getting a good clean source of vitamin D. So the raw material of vitamin D is often made in a lactose base. It is often includes certain preservatives that are maybe not so healthy for us to be consuming, but that doesn't necessarily show up on the label for the finished good. It might be on the label for the raw material that the manufacturer gets, but not on the finished product that the consumer is buying. And that's why it's important to know what your supplement company's thoughts and plans and policies are around quality and that they have good quality procedures in place for what sorts of raw materials that they choose. And that they have good quality procedures in place for testing their products and making sure they are free of harmful ingredients.

Dr. Jennifer Greer:

The other thing I would mention with vitamin D is always being aware of the amount that's in there. So vitamin D is important. We need it. Some of us need more than others. At different times of the year we might need more than others. But also, vitamin D does have the ability to be toxic in too high of amounts, and that amount can vary a bit from individual to individual. So something to talk about with your health-care practitioner if you've never taken vitamin D before and you're thinking about it, always good to start with your doctor and go from there.

Dr. Amanda Frick:

More is not always better there.

Dr. Jennifer Greer:

Agreed.

Dr. Amanda Frick:

Well, that was a bonus tidbit. But let's hop into today's main topic, which is how clinical trials guide the way Thorne formulates its products. One of the most important factors when choosing a supplement brand like you were just mentioning, is whether they're using science like clinical studies to guide their formulations, also the clean sourcing that you mentioned. But clinical trials provide the evidence behind the claims and help ensure that what you're putting into your body is doing what it's supposed to do. It's doing what it says it's going to do.

So if you missed our earlier episode on what to look for in a supplement brand, be sure to check that one out first for a broader overview of how to assess supplement companies because today we're focusing on the science that sets Thorne apart.

So, Dr. Greer, what is a clinical study or what are they and why do they matter?

Dr. Jennifer Greer:

So clinical studies are going to be those studies that are designed around understanding a ingredient or a product and how it affects human health. So when we think about research studies, there are several different types of them that are out there. There are some studies that are based on really more anecdotal evidence or what might be called a consumer opinion study. And that type of study is where you're asking people basically their thoughts. You took this product, what did you think about it? And that is not the clinical trial like we're talking about.

There's also research that's done in a lab. So those are often you will hear that described as maybe in vitro research. So that can vary from research that might be just done on cells, like individual cell lines. And that could be human cells or animal cells, and it might look at how different ingredients or products affect those things. And those types of trials, those lab research studies then inform the next higher level of trial, which is going to be a full clinical trial.

So a full clinical trial is where you're doing research with human subjects and using either ingredients or finished products to understand how that is affecting the human body. And in particular, clinical studies are important because they help to establish both efficacy and safety ingredients in our products.

Dr. Amanda Frick:

Got it. That makes a lot of sense.

So now that we know what a clinical study is, can you help guide our listeners or teach us a little bit about how Thorne uses clinical studies when we're formulating a product?

Dr. Jennifer Greer:

Yes. I would love to talk about this because I think this is so important and it's also misunderstood. For the most part, the vast majority of research that you're going to find in relation to dietary supplements is on the individual ingredients. And so supplement companies like Thorne, when they're starting to put together products that have multiple ingredients in them that are what we call formulas, we are going to first go out and look for what research is out there on those individual ingredients. And are there human clinical trials on those ingredients? And if so, what do those trials say, that, is this the safe use of those ingredients and how are they efficacious or what sort of results might they have in humans?

And then that can be used to guide what ingredients are being put together based on what your goal of a product is. They should be used to guide the amounts, so how much of an ingredient is safe, how much of an ingredient is needed in order to achieve a desired effect. And then that guides you to your finished product.

Now there are also finished-product trials. Those are fewer, currently in the dietary supplement industry, but they are growing in popularity, and companies in general are starting to put much more time and research into finished-product research as well. So it's an exciting time because we've got sort of these different pieces of clinical research that are happening. We have the individual ingredients using those to make formulas. And then ultimately starting to dive more into additional clinical trials with finished products as well.

Dr. Amanda Frick:

Yeah, I'm really excited to watch how that evolves. I understand the cost-prohibitiveness of doing it on finished products, but the more we can incorporate it and the more the industry is focusing on it, I think it's going to make a big difference. And the good thing about it from the formulation side is we may learn it does even more than what it says, so we can learn new things to say about it. So we're really confident about making the claims on the ingredient side, but from a manufacturing standpoint, we may be able to infer more benefits because they're working together, so super exciting stuff on the horizon.

Dr. Jennifer Greer:

Yeah, absolutely.

Dr. Amanda Frick:

That leads to a great topic too. What are the challenges and limitations of clinical studies in the supplement industry?

Dr. Jennifer Greer:

One of the biggest ones is really cost. So it's very expensive to conduct human clinical trials, especially those that have a large amount of people participating in them. And then beyond that, it's also very time-consuming, so it can take a very long time to complete a clinical trial from designing the trial all the way through the pieces where you have to... So you have to design your trial. You have to get your trial approved, you have to work with an IRB, which an IRB is a board that says, "Yes, we believe this trial is safe, and yes, you can do this clinical trial in humans."

And then once you're approved and you have everything in order for your clinical trial, then you can start recruiting participants. Depending on the design of your study, what type of participants, what their health needs, their health status are, their age group, where they live, there are a lot of different things that go into that. It can take a long amount of time to get enough participants to even conduct the study. And then you have the time it takes to conduct the actual study.

After the study itself is conducted, then you have to take all of the information and analyze it. And then once that's analyzed, then you can write up your research paper around it. And then once your research paper is written, you could submit it for publication, and then that's more time on the publication. So you're really talking about with particularly large-scale clinical trials, things that can take years from start to finish. So they're time-consuming, they're costly, they require a lot of manpower to make them happen on both ends, running the study and having enough participants as well.

Dr. Amanda Frick:

Yeah, I can see where all of those things add up to making it really difficult for the industry.

Dr. Jennifer Greer:

Absolutely. And that's why a lot of times you'll see that brands will focus on those sort of marketing types of things where they're using consumer feedback, versus rigorous clinical trials just because of the limitations that come around the clinical trials.

Dr. Amanda Frick:

These market studies or consumer research are great. They really help people to understand the difference, but I feel like they're icing on a cake that's made from clinical study research. They can't exist on their own. I guess you can eat spoonfuls of icing, but I don't know how that's going to work out. Probably not great long term.

Dr. Jennifer Greer:

Yeah, I agree. They both have their place and both are important, but when you line them up side by side, the clinical trial is definitely going to come out as more important or more weighty and hefty.

Dr. Amanda Frick:

Yeah, I guess it's like meat and potatoes, too. If you don't like cake and icing, then meat. You can eat potatoes, but they're better with something. 

Why should consumers care about brands like Thorne and other brands that do conduct clinical trials? What's the difference maker there?

Dr. Jennifer Greer:

There are a lot of reasons, but one of the biggest ones also here is financial. Supplements are not inexpensive. And so people are spending money, a lot of money sometimes on supplements and not even knowing if those products are designed to do what the person is looking for them to do. So having clinical trials that have been designed around a product, having products that are created around clinical trials on the individual ingredients helps you to feel more confident in what you're spending your money on and what you're putting into your body. For me, I think that that's a really important piece.

Dr. Jennifer Greer:

Another one is the safety piece as well. So clinical trials are giving us a lot of information around safety of products. Are there certain products that might be better and safer in men or in certain age groups or in women or in different types of people? And so really understanding is the product safe, is it efficacious? Does it do what it says it's going to do? Are the amounts in there appropriate? And basically, am I buying a product that is going to do what I'm looking for before I spend my money on it?

Dr. Amanda Frick:

No one likes wasting money on supplements or anything else.

Dr. Jennifer Greer:

Agreed, agreed.

Dr. Amanda Frick:

OK. Now we're going to take a short break and then we'll take some questions from our listeners.

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When it comes to your health, your body deserves the best. That's why Thorne invests in comprehensive testing, sourcing the highest quality ingredients and creating the cleanest manufacturing processes to provide unparalleled solutions for your health. Thorne's approach to quality and science has earned the trust of more than 100 professional sports and U.S. National teams, thousands of medical practitioners and millions of customers worldwide. It's also why Thorne is a trusted partner of the Mayo Clinic collaborating on clinical research and educational content. Discover more reasons to trust Thorne on your journey to a happier and healthier you by visiting thorne.com. That's T-H-O-R-N-E dot com.

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And we are back. Now it's time to take some questions from the community. Our first question this week comes from a listener who asks, "Why don't all supplements go through clinical trials?" I feel like you touched on this a little bit already, but maybe you want to give a little bit more detail.

Dr. Jennifer Greer:

Sure. Again, I think this comes down to kind of the limitations that we talked about, which is clinical trials are expensive, and they're time-consuming. And at the end of the day, in order for a supplement to still be affordable for the general public, you have to balance the amount of time and money that you're spending on clinical trials with the price that you're putting on your product. And that can really limit, especially for smaller companies, that may really limit their ability to invest in clinical trials and to have specific trials.

Now, ultimately, again, hopefully, and at least at Thorne, we are formulating our products based on existing research around the individual ingredients. So even if there's not a clinical trial on the finished product or the finished supplement good, there are going to be published clinical trials on the individual ingredients. And so that can help you to feel safe and confident in your product even if there's not a clinical trial on the finished good.

Dr. Amanda Frick:

Yeah, that makes a lot of sense. So for companies that do do clinical trials, what types of outcomes are typically studied in clinical trials? Are they focused on safety, efficacy, something else? All of the above? What is the main reason that we would do a clinical trial?

Dr. Jennifer Greer:

So really the main reason again is that safety and efficacy piece. That's the most important thing. Is this product safe and does it do what it says it's going to do? And then within that, you can really expand what your focus is on a typical study.

So if you're thinking about the finished good product of a supplement, then the question becomes, who was this supplement designed for and what challenges or needs are we trying to address for that population with this product? And then that's where you would design your clinical trial around those questions. So who is it for, and what do we want this product to do? Once you have those questions lined out, then you can design a clinical trial that helps you to understand or find the answers that you might be looking for there.

And so an example of this might be, let's say that you have a formula that you are really interested in for women, and you are specifically interested in how that product might benefit women who are experiencing symptoms related to menopause. Then you can design a study that you know your population. So the outcome you're looking for here is how does this product benefit the symptoms women who are experiencing related to menopause? Are the women of menopausal age? Where are they at in their menstrual cycles? And then you can go on there with the amount of detail you might want to know.

And so a study might look at symptom only. It might dive deeper into labs, and so it could have blood labs involved in it, looking at maybe things like hormones. If you're interested in finding out about sleep, there might be a sleep questionnaire. Or, you might partner with a wearables device to really gain some biometric data that way as well. So there's a lot of different ways and a lot of different options for designing clinical trials. It really boils down to what question do you want to answer with this trial, and then how do you want to be able to take this product and benefit the end user or the consumer?

Dr. Amanda Frick:

I love that. I love the concept of using and measuring in so many different ways. So many things we don't think about that go into all of these plans.

Dr. Jennifer Greer:

Yeah, it's really neat. And the ability to design trials and ask a lot of different questions and really distill that down into a study that makes sense, right? Because the questions are endless. There are so many things that you could ask or that you could want to test. Then you have to think about what are we trying to get out of this and how can we even recruit people for this study? If you make it so specific, you might not be able to even recruit the people that you're looking for. If you make it too broad, it might become that it's a study that takes way too long and costs way too much money. So there's definitely an art and a science to clinical trial development.

Dr. Amanda Frick:

This next question from a listener is probably one of my favorites. And again, I'm going to expand on what the first question was from them. But this says, "How does Thorne handle situations where clinical trial results don't meet your expectations? Does that affect whether a product goes to market?" I'd love for you to address that from both the side of the clinical trial data that we review during formulation on an ingredient basis and a finished product trial.

Dr. Jennifer Greer:

Yeah. Oh, gosh. I love this question also. So I want to start this off by quoting a good friend of mine who works in supplement research. And what she often says is, "All data is good data." And at the end of the day, I completely agree with her. What we can learn from a clinical trial is going to ultimately decide what our direction is moving forward. And so it might even be that your clinical trial results didn't quite meet what you were expecting, but because of them, you're able to move in a different direction.

So I'll start with this with individual ingredients. So when we are formulating a product, we're looking at what clinical research exists on individual ingredients – of course, we talked about that – determining what's safe, what dosing we're looking for, in what population of people a product might benefit, and what sorts of concerns that they have that the products could be beneficial for.

There are going to be published studies on individual ingredients. There's not always published studies already existing on combinations of individual ingredients. And so we have an idea of how they'll work together. And for the most part, we think they're going to work synergistically together. But you might find when you get into a study that they do work synergistically together, but in a different way than you think.

And so it might be that you are looking at a trial around, let's say, sleep. And so your expectation is that the product is going to benefit different phases of the sleep cycle, so supporting people in falling asleep, supporting people in staying asleep and supporting waking feeling refreshed. Well, what if in this situation you find out that the individual ingredients are really great at helping someone do those things, but when you put them together, maybe they don't wake up feeling refreshed because you know how you can sleep a little too hard sometimes and wake up feeling a little bit groggy? And so something like that might actually inform a slight difference in a final product where you might want to decrease the amounts or maybe sub out a different ingredient.

There's a lot that can be learned. You also might find out that there's something really beneficial that you weren't expecting to happen with a product. So maybe you just thought a product was going to support somebody in their sleep. But then you find out that they also, after they started taking that product, because it also maybe benefited their overall resilience to stress that they're now finding that they're able to tolerate their workouts better and put more into their exercise. So you started looking into sleep, and what you found out was, yeah, it supported their sleep quality and then also because their sleep quality was better, they were more resilient to the stress in their life, and then their exercise stamina was better too. So it can go in both directions. It doesn't just have to be a bad thing if what happens is that your results don't meet your expectations. Sometimes that's not meeting your expectations in a good way.

Dr. Amanda Frick:

Like a little bonus extra.

Dr. Jennifer Greer:

Yeah, absolutely.

Dr. Amanda Frick:

And then on that same note, how does Thorne use clinical trials on ingredients and/or finished goods to improve or adjust formulas over time? And maybe not just formulas, how about like what we say about a product? How does that get adjusted?

Dr. Jennifer Greer:

That all gets adjusted. And this is why it's really important for companies to stay up to date with new research as it's coming out and really understanding what's happening both with ingredients and finished goods, whether it's our finished goods or someone else's.

So there's a couple of different things that happened with ingredients on the raw material side. And I think this is an interesting example of this is ashwagandha extract. So you'll see studies on ashwagandha, and some of them might be different branded extracts. And those branded extracts are recommended for different purposes because they have different amounts of the active ingredients of that herb in them. And over time, new studies might reveal that they are also beneficial in ways that weren't understood before.

So with that, we might use those clinical trials to say, "Hey, you know what? We have these two different products that we're formulating. We want both of these to have ashwagandha in them, but we want one formula to have one specific extract and the other one to have a different one because those extracts have differing amounts of the active ingredients in them and the studies show that they benefit different groups of people in different ways."

Dr. Amanda Frick:

I love this ashwagandha example because it makes so much sense and it's so recent and a really trending ingredient on the market. So just to keep going with that, because it's interesting, if you know you want to take ashwagandha or you saw it on social media, your friend told you to take it, you decide you want to try it, how do you pick the one that has the type of ashwagandha or the supplier of ashwagandha that's right for you? What's the best way to go about that?

Dr. Jennifer Greer:

Yeah, OK. I love this too because this is another herb where there are multiple branded ingredients. And I think this is something that is interesting to know about ingredient studies. In general, you're going to find the most human clinical trials for ingredients that are branded versus generic ingredients.

So when you look at the label of a product, let's say you're looking for a product that has ashwagandha in it, whether that's a single or part of the formula. If you see on the label that an attribute for a specific company or a brand name for that extract, you can then go look up that brand name extract. Go to that company's website, and that will give you an even deeper dive into the research that's been done on that particular type of ashwagandha. And you can see what sort of health benefits that it might have as compared to a different ingredient. So beyond just looking at your supplement company for the finished good, looking at their website to see what they say about it, if it's branded, you can go one step further and find out even more about it.

Dr. Amanda Frick:

Yeah, it makes a lot of sense that the branded ones would have more studies because we talked about how expensive it is and how difficult it is. So why would you do studies that anybody could use? I mean, it makes sense.

Dr. Jennifer Greer:

Yeah, absolutely. And it does give a little bit of, I think a layer of protection for the consumer as well, because you can understand more about that particular ingredient when it is a branded ingredient.

Dr. Amanda Frick:

In the same way that it helps you kind of identify better supplement companies, it could help you identify supplement brands, which is super important.

Dr. Jennifer Greer:

Yeah, agreed.

Dr. Amanda Frick:

All right, folks, that is all the time we have for this week. Tune in next time for another great health and wellness conversation. Thanks for listening to the show, and thanks again, Dr. Greer, for podcasting with me.

Dr. Jennifer Greer:

Thanks for including me. I had so much fun chatting with you today.

Dr. Amanda Frick:

Thanks for listening to The Thorne Podcast. Make sure to never miss an episode by subscribing to the show on your podcast app of choice. If you've got a health or wellness question you'd like answered, simply follow our Instagram and shoot a message to @ThorneHealth. You can also learn more about the topics we discussed by visiting Thorne.com and checking out the latest news, videos and stories on Thorne's Take 5 Daily blog.

Once again, thanks for tuning in and don't forget to join us next time for another episode of The Thorne Podcast.