With so many natural products out there promising to positively influence your health, how do you know which are trustworthy and making valid claims? With scientific rigor and clinical validation! 

The strongest argument that can be made for any supplement company’s products is that they have evidence that the supplements safely and effectively support wellness. With clinical validation, we can demonstrate whether an ingredient or product actually functions as intended. 

I’m Sheena Smith, MS, MA, Clinical Research Manager at Thorne, and it is my job to design and execute research about our product’s claims. That means I not only have to understand the principles of good scientific rigor and research methods, but also the regulatory landscape that supplements function within and the nuances of the types of research questions we can and cannot study.

I also consider it to be one of my critical responsibilities to ensure that any study I’m involved with is of the highest quality and integrity. 

How do clinical studies on supplements differ from studies of pharmaceutical products? 

Although there are distinct differences in the requirements for drugs and supplements to come to market, both must provide evidence for claims about their intended effects. Research on supplements should adhere to the same high standards as for drugs, but unlike drugs, supplements can only make claims about how they affect the body’s structure and function. That is easier said than done because it can be difficult to show structure and function effects. 

Take the example of a botanical extract you expect will support healthy levels of cholesterol. How would you test that? A straight-forward study design would find people with healthy cholesterol, ask half of them to take the botanical supplement and the other half not to, and then wait to see a difference between the two groups. Sounds simple, until you realize how many people you would need to include in that study to get past random chance and the variability among humans – hundreds or thousands – and how long you would have to monitor them in order to find differences between the two groups that were strong enough to call an effect from the botanical with reasonable certainty – years, possibly decades. And if no difference shows up? Is it because the botanical doesn’t do anything related to cholesterol or just because you haven’t watched enough people for long enough or your study controls weren’t sufficient? It can be very difficult to tell. 

Why not study people with high cholesterol and see if the botanical helps them? Because that makes it a drug – a zone most supplement manufacturers deliberately avoid. 

What about studies on supplements that seem to not work? 

We tend to think about research in the context of drugs most of the time – where you usually expect to see a measurable or noticeable difference relatively quickly. 

Unlike drugs, many supplements work in the background, supporting your body’s own systems to maintain wellness – something that’s difficult to study because you’re waiting to see if something doesn’t change. So, when we see supplement studies showing no effect, it can be confusing. Does that mean the supplement doesn’t work or was the study’s design too limited to find results? 

Some supplement studies with null findings are to be expected; these studies don’t necessarily mean the product doesn’t work. It also doesn’t mean you should ignore them. So how do you know what to think? Consider the total balance of studies instead of an individual study – does the general trend of evidence support efficacy? 

The consumer wellness market has evolved significantly over the past decade, propelled by shifting consumer needs and a growing demand for premium products and greater transparency from trusted brands. 

Thorne has always been a leader in this space and will continue to be.

We believe the supplement industry should prioritize quality and transparency, and advocating for greater accountability from manufacturers (ourselves included) is the least we can do on behalf of those who trust us to support their health and wellness.

Supporting clinical research in-house is expensive and time-consuming with no guaranteed return on investment. The fact that Thorne has an in-house Clinical Affairs group is a testament to our commitment to having sound science behind our products, and I’m proud to be a core part of the team that makes this commitment a reality.