Stratum Resource post, Creating Products with Purpose: Can you easily prove product efficacy?

Does it actually work?

In the nutraceutical field, when you hear those four words, you better have an accessible and accurate answer. It seems like a no-brainer that any new product would be built upon a foundation of efficacy and quality. But unless you have the research and evidence to back up your claims and the ability to present those materials readily when asked, you run the risk of losing both industry endorsement and consumer confidence.

Ask yourself: What are the important factors to look for when assessing the research and efficacy of an ingredient you might use to formulate? Has efficacy been substantiated by competent and reliable scientific evidence?

In evaluating the quality of research and its usefulness as a measure of efficacy, several factors should be considered:
Once you have an understanding of the research supporting an ingredient of your choosing, then you’ll have a solid idea of the product claims you can safely and effectively establish for a finished product.

• Was it a clinical trial conducted in humans, or was the study done in an animal model only?

• If it is a clinical trial, what was the study design?

  1. Was it a randomized, double-blind, placebo-controlled trial (called an RCT for short)? In these studies neither the doctor nor the subject know (double-blind) whether they are taking the active treatment or a dummy pill (placebo).

  2. Clinical trials should have defined endpoints outlined in their design, so they can be observed and described adequately.

  3. One primary endpoint and a few secondary endpoints create stronger research compared to studies that measure dozens of outcomes.

  4. Objective as well as subjective measurements used as tools to determine an ingredient’s benefits are also helpful.  

  5. Research comparing efficacy to a baseline value does not account for the placebo effect, and may be used as additional support, but not as primary substantiation for claims.

• Ideally, the portfolio of research is broad as well as deep.  Clinical RCTs (described above) are the gold standard in research, but a high quality, efficacious ingredient should also be supported by mode-of-action studies (usually in vitro studies).  Population studies, independent trials and even open-label trials can provide additional support, though they are not conclusive on their own.

• Consistent dosing is paramount for understanding how beneficial an ingredient will be to consumers.  If a study utilizes a dose that is 2 to 10 times the dose being marketed, there is much less chance that the ingredient will benefit the end-consumer. Likewise, if there are multiple studies and multiple different dose amounts or methods of administration, it is very difficult to determine the optimal dosing for marketing a product containing the ingredient.

• In the dietary supplement realm in the U.S., it is important that the ingredient be supported by research in healthy individuals. This type of research is very difficult to conduct because, in essence, the goal is to fix something that isn’t broken.

Download this quick and valuable read on how product formulation and process go hand-in-hand to make sure you launch a Product with Purpose.