What is a clinical study?
A clinical study, clinical trial, or clinical research study is an investigation conducted to evaluate the safety, efficacy, and/or product-related adverse reactions of a product, therapy, device, or diagnostic test. Nutrafol conducts clinical studies to show the effectiveness of our final product formulations, something that is not required in the dietary supplement industry. As experts in hair biology and key root causes that affect hair health, Nutrafol shares our clinical study results with the scientific community through peer-reviewed publications and presents our findings at prominent dermatological and medical conferences.
How does Nutrafol design their clinical studies and why?
Nutrafol’s rigorous clinical testing includes various types of clinical studies, each of which is utilized for a specific scientific purpose. Our studies are designed with clinical and scientific experts, according to accepted research standards and the most up-to-date techniques available.
What is a publication and why does it matter that they are peer-reviewed?
A publication refers to an article or research paper that has been written and submitted for public dissemination, typically in a scientific or academic context. Publications are important because they allow researchers to share their findings with the broader scientific community, contributing to the advancement of knowledge, research, and expertise in their field. Peer review is a critical process that ensures the quality and reliability of publications.
Peer review involves the evaluation of the article by experts (peers) in the same field as the author(s) of the paper. These experts assess the validity, significance, and originality of the research before it can be published. It verifies the credibility and accuracy of the study's design, findings, and final interpretation before they are shared with the scientific community and the public.
Peer-reviewed publications are considered more credible and reputable, as compared to non-peer-reviewed papers, because their content has been vetted by experts. This helps readers and researchers trust the validity and reliability of the information presented.
What does “statistically significant” mean?
Statistically significant means that the results of a study have been analyzed by appropriate statistical tests and indicate that the outcome was unlikely to have occurred just by chance. This is crucial in scientific research because it helps determine whether findings are reliable, versus a random occurrence.
What is a randomized, placebo-controlled trial?
Randomized, placebo-controlled refers to elements of a study design used in scientific research, especially in clinical trials evaluating the effectiveness of products or interventions. It is considered a gold standard in clinical research for evaluating the efficacy of new products or ingredients because it helps control for various biases and confounding/variable factors.
When a study is randomized, 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.
In a placebo-controlled study, 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 therapeutic effect (the control group). This allows researchers to compare the effects of the actual product against those of the placebo.
What does “double-blind” mean?
A double-blind study is one in which neither the participants nor the investigators know who is receiving the test product and who is receiving an alternative product, often times the placebo.
Together, all these elements of study design—including double-blinding, randomization, and placebo-controlled—provide highly credible evidence by reducing bias and providing the most rigorous method to examine the efficacy of a product.
Does the FDA require clinical studies for supplements?
The FDA does not expressly require clinical studies for supplements, but the FDA and the FTC do require substantiation for claims used in marketing. Some brands use clinical studies to satisfy this requirement, but most supplements use ingredient studies conducted by third-party suppliers and/or perception studies in lieu of clinical studies on their finished products.
At Nutrafol, we continuously clinically test our products to ensure they deliver real results.