Decoding clinic trials for supplements and everyday products with Susanne Mitschke | Podcast 412

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Suzanne Mitschke is a clinical researcher who helps authenticate and conduct clinical trials for supplement and cosmetic brands, using various study designs and biomarkers to measure product efficacy. She emphasizes the importance of transparency and honest reporting of results, even when they may not be statistically significant.

Highlights:

Suzanne Mitschke helps supplement and cosmetic brands conduct clinical trials to authenticate their product claims.

Different study designs, such as randomized control studies and single group studies, are used to assess product efficacy.

Biomarkers and questionnaires are used to measure the impact of products on participants’ health and well-being.

Placebo effects can influence results, so subjective experiences reported by participants are also considered.

Transparency and honest reporting of results are crucial, even when the outcomes may not be statistically significant.

 

 

Dr. Justin Marchegiani: Hey guys, it's Dr. Justin Marchegiani. Welcome to the Beyond Wellness Radio podcast. Feel free and head over to justinhealth. com. We have all of our podcast transcriptions there, as well as video series on different health topics ranging from thyroid to hormones, ketogenic diets, and gluten. While you're there, you can also schedule a consult with myself, Dr.

Dr. Justin Marchegiani: J, and or our colleagues and staff to help dive into any pressing health issues you really want to get to the root cause on. Again, if you enjoy the podcast, feel free and share the information with friends or family. And enjoy the show, how you got into this field because you were doing clinical research for a while and now you've moved more into the supplement side of the fence.

Dr. Justin Marchegiani: So people will essentially hire you to kind of authenticate their products and see if they're efficacious and have a benefit. So how did you make this switch from the business world into. the clinical research world.

Susanne Mitschke: So first of all, I've never worked in the business world. I've always worked in the healthcare world.

Susanne Mitschke: And started out, you know, in clinical trials. So you hold, you got a business

Dr. Justin Marchegiani: degree and then you're like, Hey, you know, we're going to just go right into clinical research right away.

Susanne Mitschke: Exactly. Exactly. This is what, this is what interested me. So I decided to, you know right, right away work in healthcare, worked on pharmaceutical clinical studies started out in patient recruitment for, you know, different for different conditions like Alzheimer's, diabetes, a couple of dermatological conditions.

Susanne Mitschke: And then you know, pharmaceutical companies wanted to, you know, get some panels going for quality of life studies because obviously they have drugs. They know that the drugs work, but now they want to, you know, measure the impact these drugs have on the everyday lives of of people. These patients as well.

Susanne Mitschke: So we did that for a while with the company citrus labs and then kobit Came about and all clinical studies. Came to a halt. So we you know kind of were struggling waiting You know, what's, what's going to happen with us. But then interestingly enough, a couple of my friends started brands In the cosmetic world and the supplement world and the superfood world and they came to me to actually ask about you know How do we conduct clinical studies?

Susanne Mitschke: We want to have research backed product claims and you know, we want to involve research into our brand and brand strategy so you know then, you know, they asked me You know, about how much does this cost? What study design should I have? You know what how, how do I collect data? What are the methodologies that I can use?

Susanne Mitschke: And then I decided to actually run these studies for, you know, these companies and it was a huge success. So then they asked me You know, I asked them if they could refer us to a couple of their friends and they said yes So, you know, we then conducted more studies for other supplement other cosmetics companies and They liked it as well what we did especially at that price point And this is how we grew through, you know bird of mouth and now doing that for about three years Dr.

Susanne Mitschke: Justin

Dr. Justin Marchegiani: Marchegiani Oh, very cool. We'll put a link down below for your website, citruslabs. com, as well as the contact page in case you want to be in any of the clinical trials that Suzanne is conducting. There'll be links down below so you guys can just click and reach out. So first off, like, I'm a functional medicine practitioner, doctor, and I use lots of different supplements and nutrients.

Dr. Justin Marchegiani: And of course, you know, you want to use the highest grade quality products, you want to use things that are going to be bioavailable, no contamination. So if I'm a clinician and let's say I have this really well absorbed glutathione or curcumin, and I'm like, Hey, Suzanne, I want to study to figure out how well this thing works.

Dr. Justin Marchegiani: How does it, like, what does that look like? Like what biomarkers do you look at? What symptoms do you measure? What kind of patient group do you, do you recruit? How does this happen?

Susanne Mitschke: Yeah, absolutely. So first so Citrus Labs is a CRL, which stands for contract research organization. You know and brands outsource their research to us.

Susanne Mitschke: So they don't do research in house, but you know third party like like Citrus Labs. And this allows for the research to be more unbiased and more credible. And, you know, we as a CRO take care of many different things to run smoothly. So first of all, I think what we should talk about is study design.

Susanne Mitschke: So clinical studies come in many different shapes and forms and you know when you're thinking of It doesn't product work, right? We first have to think about what study design is used so typically the gold standard is an rct randomized control study where you have the product for example Cucumin and then you have a placebo which is typically, you know, just a sugar pill some studies also, you know, don't use Any placebo they they have a control group where participants basically don't do anything and then, you know, you measure the impact based on questionnaires, for example.

Susanne Mitschke: So for example, when we are looking at for example, gastrointestinal conditions, they are amazing validated questionnaires where we can see if the product actually had an impact, but then obviously You know, every good research ideally includes biomarkers. We can include, for example, blood work, you know, looking at different markers here that it always depends on the product, which ones we are looking at, then they can be stool samples.

Susanne Mitschke: They can be skin swaps for example, scalp swaps anything you can think of can be done here. And then, you know, basically, we're looking at the impact. Now, as I mentioned before, randomized control studies, typically the gold standard, but there are other study designs. There is one called a crossover study, which is part of the study.

Susanne Mitschke: the randomized control family. And here they have one group and then this group both goes through the intervention and the placebo or the control, for example. And then they are also single group studies, single group studies, as the name implies, only have one group. And typically it's just the intervention and nothing else.

Susanne Mitschke: Now a lot of researchers don't feel good about single group studies, but they are great pilot studies, especially if, you know, you don't really know if your product work or if you don't really know how your product works. You know, this can be like a good indicator to actually, you know, see if it works.

Susanne Mitschke: And then on the other hand, obviously single group studies are cheaper. So a lot of brands. Run, you know single group studies and in my personal opinion, especially when i'm thinking of consumers right which study should they trust? So I personally trust single group studies more that involve biomarkers and also show, you know, an effect in before and after in baseline and end line versus randomized control studies that only involve questionnaire.

Susanne Mitschke: Dr. Justin

Dr. Justin Marchegiani: Marchegiani So for instance, if I don't have a control group, but I have this herb that's going to help modulate cortisol or increase testosterone, we could take a biomarker serum or cortisol sample before and then we can Dr. Add the intervention in a month later, retest and then see where that biomarker sits.

Susanne Mitschke: Exactly. Would you also look at like a symptom

Dr. Justin Marchegiani: questionnaire to see, oh, maybe libido went up, maybe mood went up, maybe energy went up. Would you look at symptoms along with that biomarker?

Susanne Mitschke: Yeah, we would do that as well. And you know, a lot of studies, Involve both but unfortunately a lot of studies especially in the supplement superfood world only involve Questionnaires and not so much the biomarkers.

Susanne Mitschke: So a lot of brands would kind of be a chicken out of doing an actual Cortisol test for example or testosterone test on the other hand because they fear that you know There's no effect in blood work.

Dr. Justin Marchegiani: So they'll look at just their symptoms instead

Susanne Mitschke: Exactly. They look at symptoms and oftentimes you know, you have just like study specific questionnaires that that you check for, for example, as you mentioned libido, obviously they are for libido, for example, they are a bunch of validated questionnaires as well.

Susanne Mitschke: But oftentimes you know, They are just trying to get some check marks on their hair. Yeah, and

Dr. Justin Marchegiani: the placebo, the placebo is a real thing, and so that's a, you know, 20 percent potential bump. So it's nice to have some biomarkers that, you know, are a little bit more objective. So, that makes sense. And so let's say someone's hiring you for a hair, a hair product that's going to improve hair count or hair quality.

Dr. Justin Marchegiani: How do you test that? Are you doing like, like, trichoscopies and looking and measuring hair count, or is it more just subjective stuff when it comes to those things?

Susanne Mitschke: Yes, I mean hair is currently really on trend. Oh,

Dr. Justin Marchegiani: it's it's big. I see it everywhere.

Susanne Mitschke: It is big. Yes so for hair that's that's really interesting.

Susanne Mitschke: Because hair, you know, obviously you have you have You know objective Things right, but then you also have tests that participants can do in their home so for example a hair fall test is something that I personally really like so there's for example that brush test that participants do in the comfort of their home and then you know doing a hair count at home Additionally for the hair count.

Susanne Mitschke: We often also just ask them Kind of to roll their hair together and then you know Place it next to a ruler And then you can see basically, you know, is the ball of hair bigger smaller or the same right for the baseline midline end line for example and then there's another great thing that is frequently used in cosmetic studies which is expert grading which means that a dermatologist will actually look at, in that case, the hair.

Susanne Mitschke: And then, you know, based on you know, based on their judgment then, you know, makes a conclusion that, for example, hair is thicker, more healthy has more shine to it or even, you know, there's more hair. Dr.

Dr. Justin Marchegiani: Justin Marchegiani Interesting. Now, tell me a little bit, so someone comes in, they're trying to hire you for, for a product to provide some level of validation or make a claim based on the data, what happens when there isn't a clinical outcome that's efficacious or statistically significant?

Dr. Justin Marchegiani: How do you how does that work?

Susanne Mitschke: Yeah, you know, that's sometimes you know, it happens. It's unfortunate. And that typically we see that typically happen with biomarkers. But that doesn't actually mean that the product doesn't work. Because you know, placebo effect is even though, you know, you don't You don't see anything in in the actual biomarkers doesn't mean that the product doesn't give you a better quality of life so this is you know where these questionnaires and surveys and the more like the perception of consumers tie in and you know oftentimes You know that part Is good and that is great and then you know brands can still use this part.

Susanne Mitschke: But in my opinion and Fortunately most of our most of our clients do that. They're actually honest and hey We did that study, you know, biomarkers came back as, you know, mixed or not statistically significant, but this is what participants reported. Interesting. How do people try to fudge the data? I mean, typically what I see is people will talk about relative risk and they will never give the context of absolute risk behind it.

Dr. Justin Marchegiani: So for instance, I see a lot with some of the older statin trials, they would, they would look at, Oh, well, you know, you have two heart attacks per, you know, 1000 people taking this drug and then not taking the drug. The placebo group had three, three heart attacks per 1000. Therefore, the relative risk ratio is 33 percent less than they come out.

Dr. Justin Marchegiani: Big headline statins reduce heart attacks by 33%, right? Using that relative risk ratio where Absolutely. Okay. I guess if you're using a relative risk, but it's really only one person less per 1000 people taking the drug, right? That's just kind of a hypothetical. Any, any thoughts on the kind of the relative risk versus absolute risk and how people can kind of hide behind that a little bit without the context?

Susanne Mitschke: Yeah, I think, you know, especially when you're looking at supplements. And think about, you know, does that supplement actually work? Does that not work, right? It's not for, for this industry. It's, it's, it's less about, you know, absolute risk, relative risk. It's more about claims and percentage. Yeah. You know, it's more about 100 percent of participants, you know, have increased libido after using this product, for example, and So for us you know, we don't forge any data.

Susanne Mitschke: The data is the data and very interesting. What we have seen is so this, this week we actually launched a consumer report and probably some of the listeners probably you know, feel the same that consumers don't feel inclined to buy a product 100 percent or high 90 percent result,

Dr. Justin Marchegiani: because

Susanne Mitschke: they think that it's.

Susanne Mitschke: Yeah, it doesn't and apparently the sweet spot is between 50 and 75 percent because consumers feel that you know Even when when a claim is just 50 that means that every other person has an effect and that is good enough You know to kind of buy a product and try it out but again, you know, I think that transparency is the most important thing and that is relevant for consumers, right?

Susanne Mitschke: And You know When I see these websites, right that you know brands make claims and the claims are next to their product and then there's this asterisk and then that leads to you know, based on a A clinical study conducted by a third party party without any further information. So to me, this raises questions that everybody should ask.

Susanne Mitschke: And it's about, you know, is this based on existing research on ingredient research or was this study conducted on the actual product that I am seeing right. And that I should buy. And then second, What was the study design? Was it a randomized control study? Crossover study perception study, a single group study.

Susanne Mitschke: How were the participants selected and what were these criteria and how many participants were in the study in the first place? You know what was the methodology behind the study, you know, methodology, basically how was the data collected? Was it questionnaires? Was it biomarkers? What?

Susanne Mitschke: Biomarkers? And then also who conducted the study? What was the actual research question? Like, what was the study supposed to find out in the first place? And then also, how long was the intervention period? And I think that, you know, these were, these are really the questions that consumers deserve to know.

Susanne Mitschke: And to me, it's always a red flag when brands don't tell me more about their study and, you know, we can't find these studies. I think, you know, we talked about earlier, you know, how, how can consumers. You know, read a research paper. So that is the, that is one major issue, right? Most, most supplement studies that friends conduct aren't published because they only care about, they only care about the, um, the results, which is the claims, but fortunately there is a website called clinical trials.

Susanne Mitschke: gov which is a central database of clinical trials and many brands actually do a great job. with having a, you know, a dedicated clinical study page in which they include all relevant data and then also link to their study on clinicaltrials. gov.

Dr. Justin Marchegiani: Very cool. So we talked about it earlier. You kind of hit it regarding, you know, you mentioned the studies that aren't mentioned.

Dr. Justin Marchegiani: You kind of gave us that resource of ones that aren't posted. But when, when someone has access to an abstract, which is just the, you know, front page of the study where you have kind of your. your methodology and maybe it has your conclusion on there. How do you go and read an abstract? If you're looking at a claim, whether it's, I don't know, saw Palmetto for hair loss, for instance, how do you go look at a study?

Dr. Justin Marchegiani: How did you go read an abstract? What do you look at first? Or do you just start from the top and go down? Or do you hone in in certain areas?

Susanne Mitschke: So it depends what I want to find out, right? But for me, the most important thing is is participants, participant selection. Because that, that kind of, you know, shows.

Susanne Mitschke: So for example, we talked about hair. Let's talk about gray hair. So some premature gray hair you know, leads, leads to vitamin deficiencies, right? And if you only recruit participants that have certain deficiencies, Right. And then they take a supplement that ha that kind of, you know, helps with these deficiencies.

Susanne Mitschke: And then their gray hair, you know, vanishes and, you know, they, their natural hair color comes out again. Then, you know, this kind of leads to me, you know, how, thinking of how generalizable that study is because we are now looking at a very particular subset. of people, right? So this is, this is something that I typically look at.

Susanne Mitschke: You know, generalizability who are the participants, what were the participant criteria and does it make sense to actually make a claim then based on that?

Dr. Justin Marchegiani: That makes sense. Absolutely. All right. Anything else you want to kind of give us a glimpse in just from the average person that's trying to decode research that's out there, just from your perspective, you know, designing these studies, any other Information or insight you want to provide on that?

Susanne Mitschke: Yeah. So I think, you know, when, when you're really looking at a study I think naturally we are looking at the abstract, but read the headline, like typically the headline includes part of, you know, what's the research about in the first place? What did the researchers try to find out and really try to try to hone in on what was the research question.

Susanne Mitschke: And then, you know, Make yourself a little bit more familiar with different study designs and don't demonize you know study designs that are not a randomized control study because many different things go into why why a company or, you know, specific business unit within the company decided not to conduct a randomized control study, right?

Susanne Mitschke: It's not necessarily that they are not believing in their product. It can also just be a budget question because randomized control studies still are expensive. And, So this, you know, this is, and to me, it's like, what, what's the alternative, right? Is the alternative to only conduct randomized control studies or no study at all?

Susanne Mitschke: Or is the alternative a single crew clinical study that is very well designed? So this is, That's one thing that you know, I really wish more people would understand that just because someone didn't run a randomized control study doesn't mean that they don't believe in their product.

Dr. Justin Marchegiani: No, that makes sense.

Dr. Justin Marchegiani: Anything else you want to highlight regarding kind of cutting edge research that you were utilizing or cutting edge technology that you're using are using to streamline or improve the research that you're doing at all? Anything new coming down that pipe?

Susanne Mitschke: Yeah. So you know, obviously through COVID as well, a lot of pharmaceutical companies we're starting to finally utilizing it, which is decentralized clinical studies.

Susanne Mitschke: So all studies that we run are entirely decentralized. But even though they're decentralized, we can still utilize you know, blood work blood work through, you know, CLIA certified labs which is awesome. Some some other tests like stool samples, for example or other microbiome tests from the skin, for example, can be easily, you know, done by consumers.

Susanne Mitschke: patient participants in the comfort of their own home which is fantastic. So this is something that I'm really excited about decentralized clinical studies because it also makes studies more accessible and makes them more cost efficient.

Dr. Justin Marchegiani: Excellent. Very cool. Anything else right now that you think is really important that you want to highlight on the supplement research kind of front?

Dr. Justin Marchegiani: I know that's where you kind of live most of the time. Anything else really cool happening coming down that pipe?

Susanne Mitschke: So personally, I'm really excited about, you know, all the, all the different different supplements I'm seeing in women's health. That's cool. I'll hear about that. I feel like. Yeah, I feel like women's health, you know, has been mostly neglected in the past couple of decades.

Susanne Mitschke: Well,

Dr. Justin Marchegiani: I think what happened is you had the women's health initiative study in the early 2000s and they used horse, horse estrogen and progesterone. Then they saw all these cancer risks and then they were like, Oh, okay. And then like, Basically, it was kind of like a pause button in regards to, well, what do you do now?

Dr. Justin Marchegiani: A lot of clinicians like myself are using lower dose bioidentical or using herbs and things like that. But conventional medicine kind of just hit the pause button for like you know, over a decade on that. It seemed like

Susanne Mitschke: exactly, exactly. And it you know, the result was you know, now I think, I think now the big issue is to convince providers that they actually made a mistake in that study.

Susanne Mitschke: But, you know, that is just like one little part. You know, when you're looking even at clinical studies I think the first women to participate in clinical studies were in the 90s because investigators were under the impression that you know, our hormones would mess with the clinical study results.

Susanne Mitschke: And that, you know, that's, that's pretty bad. This is why, you know, a lot of dosages, for example, of drugs are more like, you know, You know tied towards men versus women. So there's still like you know, lots of things to do But what i'm what i'm really excited about is conditions, you know, like pcos or endo or fibroids, for example they are really, you know getting the traction they deserve because many many women actually suffer from from these You know, very women's specific conditions and supplements are kind of filling that void.

Susanne Mitschke: That is something. Yeah. And that is, that is something great. And we are working with many brands in the women's health sector, not only on these conditions that actually helping and that do great work that are efficacious. But we are also seeing You know, more traction on the sexual wellness front, for example.

Susanne Mitschke: And working with one company, you know, that kind of wants to do the Viagra for women which is also really awesome.

Dr. Justin Marchegiani: That's cool. I want to hear, get a little insight of what supplements and nutrients you're seeing that are working, but just kind of go back to the women's health initiative study.

Dr. Justin Marchegiani: I think a lot of drug companies, they have this zester or vim and vigor to focus on things that are patentable yet. You know, the problem with using patentable drugs, there may be safer, non patentable like, like some of the bioidentical options that you really can't patent but maybe we're not going to put the research into that because there's not an ROI for all the research funding and money that goes into it.

Dr. Justin Marchegiani: So, There, there's that kind of component to, do you see that too?

Susanne Mitschke: Yeah, absolutely. And then you, you had to, you had to create a point, right. Funding. So one, one thing that I, I always think like, who would fund this? Right. So a lot of, a lot of comp, a lot of consumers, right. When they also see a study and then they see, Oh, who funded it?

Susanne Mitschke: Oh, it was actually the brand that funded it. And then I'm like, yeah, because who, who else would fund it? It's true. Just because. Yeah, just because a brand funded their own study doesn't mean that the results are scourge or biased.

Dr. Justin Marchegiani: Yeah, and usually a brand, they're looking at some clinical data that's already there to say, Hey, look, we should make something like this because there's data on, I don't know, using progesterone from YLGM and let's do our own product and our own thing and let's see how it goes.

Dr. Justin Marchegiani: Most people aren't just, they're like usually creating a product out of thin air. They're usually looking at the data a little bit to say, what direction should we go in? Would you agree? Okay.

Susanne Mitschke: Absolutely. 100 percent agree. Dr. Justin Marchegiani

Dr. Justin Marchegiani: Now tell me a little bit, what are you seeing coming out on the female hormone side that, that's beneficial in some of the studies you're doing?

Susanne Mitschke: That's a, that's a really good question that I actually would need to look up right now. So off the

Dr. Justin Marchegiani: top of your head, is, is there one thing that just comes to mind? I know you mentioned like some of the libido stuff or some of the, the female hormones or fibroids or endometriosis, anything that pops to mind?

Susanne Mitschke: Yeah, so we are doing it's actually his second study with that one company and they they are kind of reviving traditional Chinese medicine and it's working and it's, it's fantastic. And so their, their first study was focused on PMS. And then during that study, you know, they were already, they were already thinking that this could also help with other conditions like PCOS, for example.

Susanne Mitschke: So now they are actually rolling out more studies. Also, you know, in, in more conditions apart from, you know, just the, the PMS doing studies in PCOS and and also fibroids. And it's, it's really amazing to see how this actually helps women. And so this is one thing that I really like and, but on the other side you know, it's, it's also hard because our studies have only like, you know, we have like a, We have, for example, 100 participants, 200 participants, 300 participants.

Susanne Mitschke: And then when the word goes out that, you know, products actually work, that means that, you know, a lot of people actually want to be in that study to actually contribute then we actually have spots. So we have specifically for our women's health studies, typically you know, we can recruit in like two, three, four hours.

Susanne Mitschke: And then unfortunately we have to, you know, kind of say that, you know, studies are full, unfortunately to women that actually want to participate. Interesting. Very cool. And what about the, what was that traditional Chinese herb? that was helpful.

Susanne Mitschke: So it was actually a mix of I think they have 10, 15 different herbs in there, which is, which is pretty awesome.

Dr. Justin Marchegiani: Okay, cool. Any other specific nutrients that come to mind?

Susanne Mitschke: We see A lot of revival on the on the melatonin front, which is awesome. Let's hear

Dr. Justin Marchegiani: about that.

Susanne Mitschke: And I, I, yeah, I think that, you know, sleep is obviously an issue. Mm-Hmm. That many still struggle. And it is. So the, the parents that we see pop up they kind of make, make a, an entire routine out of it.

Susanne Mitschke: Right. It's not necessarily about you know, this is a supplement. you, you take it and then you sleep well. It's about, you know, making, making a, a holistic routine out of it instead of just, you know, saying, take that 30 minutes before bedtime. It's, you know, a routine for unwinding that we are right now seeing that contributes to that as well.

Dr. Justin Marchegiani: Any studies out of the gate that come to your mind that like you, that you use this nutrient or this compound and it produced amazing. results that you were like kind of blown away by anything like that that comes to mind?

Susanne Mitschke: So we have done recently completed a study on colostrum. And this is something that is, you know, still fairly new. But I know that, you know, it, it actually produced amazing results.

Dr. Justin Marchegiani: Really? Excellent. And what were the parameters? Was it just immune health? Was it, was it gut health? What was it looking at specifically?

Susanne Mitschke: So we were looking at gut health. We were also looking at overall, you know we were looking at performance breakout performance as well. And we were also looking at skin skin hair as well.

Dr. Justin Marchegiani: Very cool. Any other really cool areas you see coming up that you're really excited, excited about regarding innovation or certain supplements, areas that are just providing amazing results, anything that you're really passionate that you wanted to highlight?

Dr. Justin Marchegiani: I

Susanne Mitschke: think we already talked about, you know, new stuff that's actually not that new, but that wasn't just, you know, commercialized. I think I'm also really excited about the whole longevity the whole longevity area which is pretty awesome. And excited to actually test, you know, supplements also in regards to all of these longevity clocks as well.

Susanne Mitschke: That are quite new to actually see, you know, if it works. Because I think a lot, a lot of these supplements, like for example You know, NAD, for example, have, have mixed results, right? So it would, I, I think, I'm, I'm personally really excited about, you know, seeing more of these studies happening.

Susanne Mitschke: And to me, like, you know, mixed results don't really matter because we should, we should look at these studies also, you know, kind of stand alone and see, you know, again, who was, what was the question? What was the research question? What were the, who were the participants? What were the selection criteria?

Susanne Mitschke: Right. And then see if, if it makes sense you know, personally to actually take these supplements or not.

Dr. Justin Marchegiani: That makes sense. Based on kind of your experience, doing a lot of clinical trials, is there anything that you would modify If you could, right, like if you had your magic wand to make clinical trials be more efficient as a whole, is there anything that you would modify?

Susanne Mitschke: So I think that, you know, when looking at clinical trials, especially in the supplements space we, we have seen, you know, especially for, for these, for these product claims, we've seen like a wide, wide range. Happening recently. But then the, the FTC kind of, you know, introduced guidelines last year in December and basically told brands that they need an RCT to make a health claim, but they are obviously a thousand exceptions to that.

Susanne Mitschke: So brands have still allowed to use third party. Research about, you know, ingredient research to make these claims. So I think to make them more efficient and to also make them more accessible if I would have a magic wand, I would I would make these FTC guidelines very specific and would give specific examples and would not demonize Other study designs outside of the RCT.

Dr. Justin Marchegiani: Are there any other products out there that there's a lot of hype behind? People think, Oh, this is a great product, but you really just haven't seen the research to support its efficacy. Anything like that come to mind?

Susanne Mitschke: So all of the brands that we work with fortunately, you know, have a pretty clear understanding. Yeah, what their product does and what it doesn't do. And you know, oftentimes when, when we are talking to to brand owners or, you know to marketing people within that brand, they have a specific thing in mind, what their product does.

Susanne Mitschke: And then, you know, my research team is able to kind of help them understand what's realistic and what's not realistic but I I think you know, especially when it comes to consumer expectation I think what we are right now seeing is we talked about it right that focus on hair And it can actually, you know, some products actually really work with hair and hair growth, but it only works in a subset of the population.

Susanne Mitschke: So it's not so much about, you know, not having the results. It's more about generalizability and about you know, about is, you know, what, what do consumers actually expect the supplement to do? Because supplements are supplements for a reason, right? They are, they are not drugs. But supplements can absolutely help.

Dr. Justin Marchegiani: Excellent. Awesome. Suzanne, we'll put your links and info down below. Citrus labs. com citrus labs. com slash contact. If you want to be in any of Suzanne's clinical trials. They'll be there for you. Anything else you want to leave the listeners with, Suzanne?

Susanne Mitschke: I think it was a great conversation. Thank you so much.

Dr. Justin Marchegiani: Awesome. Thanks, Suzanne. All right. You have an awesome day.

Susanne Mitschke: Thank you. You too. Right. They are, they are not drugs but supplements can absolutely help.

Dr. Justin Marchegiani: Excellent. Awesome. Suzanne, we'll put your links and info down below. Citruslabs. com. Citruslabs. com slash contact. If you want to be in any of Suzanne's clinical trials, they'll be there for you.

Dr. Justin Marchegiani: Anything else you want to leave the listeners with, Suzanne?

Susanne Mitschke: I think it was a great conversation. Thank you so much.

Dr. Justin Marchegiani: Awesome. Thanks, Suzanne. All right. You have an awesome day.

Susanne Mitschke: Thank you. You too.

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