Creating an effective healthy population study can be painful. Creating one that produces substantial claims, well that is just down right painfull-er.
Read our latest whitepaper and make it even less painfull-er-er on you.
Our most recent NEM® clinical trial, which was conducted in a truly healthy population, opens up new possibilities for claims language, and in combination with its previously published trials, builds a strong foundation for a successful joint health formula.
Subjects in the study felt a difference in as little as 4 days when taking NEM.*
This study provides substantial label and marketing claims you can actually use.
Results show NEM supports multiple joint health areas, removing the need for extra ingredients.
Our first of its kind, healthy population, joint health clinical study supports the use of pain and stiffness reduction label claims, as well as a cartilage protection label claim - all from just one ingredient and only 500 mg once a day.*
NEM® rapidly improved recovery from exercise-induced joint pain (Day 8) and stiffness (Day 4)
Significantly reduced discomfort from stiffness immediately following exercise (stiffness, Day 7).
Lasting decrease in the cartilage degradation biomarker CTX-II.
Showed the beneficial effects of NEM vs. Placebo in exercise-induced joint pain, stiffness, and cartilage turnover for the first time in healthy postmenopausal women; supports that NEM should assist them in staying active and maintaining healthy joints as they age.
The knowledge that one's joint cartilage may also be protected from damage due to exercise should further improve one's inclination to exercise and continue to exercise.
About the Whitepaper
All clinical trials are important, but having a clinical trial in a healthy population is virtually mandatory for making any type of meaningful claims. The purpose of the whitepaper below is to provide insight into the importance of conducting not just any ol' clinical trial, but looking instead to ingredients with clinical trials in healthy populations. Experience with clinical trials has given our team an understanding that 'Research is Not Enough', 'Healthy Population is a Must', there's 'Success in the Details', as well as some other 'Key Takeaways' - all of which are covered below.
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Dietary supplements have faced increased scrutiny in recent years for their claims made either on labeling or in marketing pieces. Consequently, clinical trials conducted to support these claims have been put under a microscope, both by regulatory authorities and consumers.
Choosing a clinically-supported ingredient is an important choice for formulators. However, it has become clear that having a research-backed ingredient is no longer enough. Checking the box of having a clinical trial done is not sufficient to satisfy regulatory authorities as well as discerning, health-minded customers.
The Federal Trade Commission (FTC) is looking for well-controlled, human clinical trials to support product claims.(1)
However, many trials may be case-specific or at least dependent upon the type of product and claims that are intended to be made.(1)
In FTC's dietary supplement advertising guide, an emphasis is placed not only upon statistical significance, but the factors that dictate the clinical significance of those findings-including the population.(2) In their guide, the FTC posed a question for marketers to consider:
"Does the study population reflect the characteristics and lifestyle of the population targeted by the ad? (2)"
The quote on the previous page is a fair point, as some ingredients may have a clinical effect that is much larger in a population with a major disease, but may have less dramatic effects in a healthy population. Nonetheless, using a healthy population is what creates the greatest opportunity for dietary supplement brands and marketers to generalize the benefits of products to a larger audience.
Even without considering the broader market appeal for claims, the advantages of utilizing a healthy population extend to FDA regulations as well. Discussing in marketing copy a study that involves a population with a diagnosed disease may be an implied disease claim in the eyes of the FDA.
Using a truly healthy population gives brands and marketers greater freedom to talk about the substantiation behind a product's ingredients in multiple mediums, (print, digital, etc.), without worrying about the need to censor or omit certain details of the study.
In an age of digital access and transparency, omitting details such as the subject demographics of a study may only leave customers with more questions and concerns than answers. In FDA's guidance (non-binding recommendations) for dietary supplement substantiation, similar to FTC, the FDA emphasized that the health status of the study subjects is an important consideration.(3)
When deciding what ingredients are going to serve as the "clinically- backed anchor" to support your product, it's not just what the claims are, but how they can be applied to your customers and how your customers can be informed of them.
Dietary supplement clinical research design and planning doesn't stop at the laboratory. To allow brands and marketers the greatest opportunities to cite and have meaningful discussions with customers about new research, one must also be careful about the title of the manuscript and the journal in which the clinical trial is published.
Even if all of the above criteria are met, it's also important to choose a peer reviewed journal. Per FDA, although unpublished studies can serve as substantiation, clinical trials published in peer reviewed journals are more likely to have been reviewed by qualified experts(3) and as a result, are more likely to withstand scrutiny from regulatory authorities and the public.
A recent publication(4) examining the effect of NEM® brand natural eggshell membrane on protecting cartilage was carefully developed by Stratum Nutrition (Carthage, MO, USA). The journal, Clinical Interventions in Aging does not include any mention of disease states, and the same can be said for the manuscript title ("Beneficial effects of natural eggshell membrane versus placebo in exercise-induced joint pain, stiffness, and cartilage turnover in healthy, postmenopausal women.") The study went a step further and used a biomarker, (C-terminal cross-linked telopeptide of type-II collagen (CTX-II)), that has been recognized as an indicator of cartilage degradation but is not considered a diagnostic tool for arthritic diseases (presently). This allows brands to discuss the cartilage protection benefits of NEM® while simultaneously avoiding disease claims.
While human clinical trials are key to supporting claims, it is equally as important to ensure the population studied represents the customers that are using the product.
Where the clinical trial is published can greatly influence the ability to incorporate said trial into marketing efforts.
The measures used to assess the effects in the population may be just as important when it comes to explaining the benefits of a product to customers.
For a list of references, please download the PDF.