What Are Clinical Studies, and Why Are They Important for Supplements?

You may hear companies talking about how they’ve done clinical studies or clinical research on their products, but what does that really mean? Read on to learn why you should care about clinical studies for supplements and what they can help you understand about a product.

A clinical study is a study done on humans– as opposed to research studies, which could be done on cells, animals, or other non-human subjects. For dietary supplements, clinical studies are completed to evaluate a product’s safety and efficacy.¹ While clinical studies are a necessary part of the pharmaceutical medication approval process, you may be surprised to learn that the Food and Drug Administration (FDA) does not expressly require them for supplements.²

With all of the useful information clinical studies give us, you may be wondering why all supplement companies don’t complete them anyway. Unfortunately, given that supplement studies involve companies voluntarily investing ample time, money, and resources to ensure they’re completed correctly, clinical studies can be a rarity in the world of dietary supplements. 

Nutrafol makes it a priority to invest in clinical studies, a step that is not required by the FDA to market supplements.

Clinical studies can help provide evidence of safety and effectiveness. These are the two foundations of what makes a worthwhile product: substantiation that it can be safely used by the target consumer and that it can actually provide the intended benefits.

In the United States, supplement manufacturers are required to verify that their supplement ingredients satisfy FDA safety criteria. However, unlike medications, a supplement's actual efficacy isn’t evaluated by FDA. This means that while the FDA monitors to ensure products don’t cause harm to consumers, they generally aren’t verifying if the product really works.^3,4

This doesn’t mean the company can say whatever it wants about the product and its benefits. The FDA, in partnership with the Federal Trade Commission (FTC), requires that claims on a product have reasonable data behind them. Sometimes, a company’s claims about what a product can do for a consumer will be based on ingredient studies. This means companies are pulling information from established, existing research that has shown what each independent ingredient is capable of, and that's useful in determining what a supplement can do. However, a more complex formula of 10+ ingredients may have different effects than each ingredient on its own. Relying only on individual ingredient claims may miss the big picture, and companies can’t fully understand what the  formula’s effects will be: Do the ingredients work together, and does using the formulation achieve the desired results? 

Clinical studies using the whole formula, on the other hand, substantiate the effectiveness and show results with real human subjects. Formula safety is first reviewed by expert toxicologists prior to the clinical study. Clinical studies then help verify the safety of use—did anything unexpected occur? Were there adverse events linked to the product? This supports that a product is safe when it is used as intended and means it has been vetted by the target population.

To steer clinical studies, an international set of guidelines exists called Good Clinical Practice (GCP). These are set by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and adopted and enforced by the FDA. GCP guidelines make sure the study is conducted in a safe and ethical manner, that the results of a study are reliable, credible, and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. These guidelines thoroughly cover every step of a clinical study, including how it’s designed, conducted, performed, monitored, investigated, audited, recorded, analyzed, and reported.⁵

There are several types of clinical studies, depending on their design, and each type has its strengths. They can all contribute valuable insights to reinforce overall clinical evidence for a supplement, helping consumers gain a comprehensive understanding of a product.

A Proof of Concept Study is done in a wider group of participants to determine what type of consumer might respond best to the product. Before and After Consumer Perception Studies help provide visual examples for consumers to better understand what the benefits of a product might be. Randomized, placebo-controlled trials, meanwhile, are considered a gold standard in clinical research for evaluating the efficacy of new products or ingredients because this study design helps control for various biases and confounding/variable factors.

All studies have a “present question,” or hypothesis, for what’s anticipated to occur during the study. By setting this endpoint ahead of time, researchers are saying “if we achieve this endpoint, then the intervention worked.” The results of a study either confirms or denies the anticipated effect, and can also help determine the level of effectiveness from an intervention. For example, a study’s question might be, “Will this product improve hair growth?” and an endpoint may be a statistically significant increase in hair count. There may also be secondary endpoints, which gather other information about other effects of the intervention, like changes in hair quality. Whether primary or secondary, these endpoints are always determined before the study even begins.

Depending on a study, the information it gathers might be objective, meaning it’s something measurable (like hair count), or subjective, meaning it depends on a person’s observation and not something quantifiable (like a participants responses to a questionnaire on their perception of hair changes, such as hair texture or shine). Both are valuable, with objective measurements decreasing bias, and subjective measurements collecting data that can’t be measured by instruments. Results may include expert ratings, which utilizes different grading scales to determine improvements over time by an expert, like a dermatologist. 

Whatever the study type, the information gathered then gives everyone a better understanding of what to expect when using the product. While Randomized Controlled Trials are considered the gold standard for clinical evidence, each type of clinical study offers valuable insights for consumers.⁶ Read on to learn more about Randomized Controlled Trials.

Randomized, placebo-controlled trials (RCT) are thought to provide the most reliable answers regarding efficacy, because this study design allows researchers to establish a cause-and-effect relationship between the studied product and the outcome while reducing bias.⁶ In a randomized, placebo-controlled trial, participants are randomly assigned to different groups. This randomness helps to minimize bias and ensures that the subjects aren't purposely assigned to a group that may change the outcome. One group of participants receives the product or ingredient being tested (the active group), while another group receives a placebo—a dummy product that looks like the real product but has no formula ingredients or beneficial effect (the control group). This allows researchers to compare the effects of the actual product against those of the placebo.^1,6 

RCTs are almost always blinded. There are different types of blinding. Most commonly, when a trial is blinded, either the participants or both the participants and the trial investigators do not know who is receiving the real product versus the placebo. This helps reduce bias while participants express their experiences and investigators perform evaluations. Whether participants are assigned to active or placebo groups is randomized. This makes it so people’s preferences or preconceived ideas don’t influence the trial results.^1,6 

Proper clinical trials are dictated by protocols that are carefully planned ahead of time, pre-established ways of measuring results (or endpoints), and unbiased methods of collecting data. This ensures a thorough, useful study will be performed that isn’t prejudiced toward success or failure.^1,6  

Though not required by the FDA, Nutrafol prioritizes investing in high-level clinical studies, which we share with the scientific community through peer-reviewed publications and by presenting our findings at prominent medical conferences. This means our studies undergo scrutiny by experts in the field before publication.

All of our clinical studies are conducted by independent clinical research centers, and, following standards set for US clinical studies, are approved by an institutional review board, and are conducted in compliance with GCP guidelines. Having our studies completed by independent clinical research centers reduces the risk of bias that can occur when studies are done in-house only. Having an institutional review board as well as following GCP means that the methods and results of each study have been meticulously watched and checked. 

Nutrafol’s rigorous clinical testing includes various types of clinical studies, each of which is utilized for a specific scientific purpose, including Randomized Controlled Trials. Our studies are designed in collaboration with clinical and scientific experts according to accepted research standards and utilizing the most up-to-date techniques available. Within Nutrafol, we hold ourselves to a high standard. We have completed, published, and/or ongoing studies on all of our Hair Growth Nutraceuticals, our Clear Skin Nutraceutical, and many of our scalp care products.