I miss the old days, when we were encouraged to have a glass of red wine and chocolate every day for the antioxidant benefits. In the ’90s and the ’00s, we loved the idea that a cabernet and a Toblerone or a pinot and a Ferrero Rocher would add heart-healthy years to our (then young) lives. So when we saw an NAD case involving chocolate called Zen-X promising to boost long-term cognitive benefits, we said yes please. Our personal favorite claim to “ditch that Xanax meet Zen-X” was voluntarily discontinued. But NAD focused on the claim that you get “calm, collected, and clear headed in one delicious bite.” And the resulting decision hearkens back to the old days of NAD and its CRN-backed dietary supplement program, with a study-by-study dissection of the proffered evidence to define what is and is not competent and reliable scientific evidence or CRSE.
We were disappointed not to be asked to be a part of a clinical trial on the Zen-X product itself, as we would have happily munched on placebo or product chocolate in the name of science. The company relied, as many do, on existing ingredient studies available in the product literature to support the claim. The ingredients in the product included L-theanine, caffeine, kanna and saffron. NAD found that the saffron studies supported the claim but that the other ingredient studies did not. What were the differences?
First, kudos to the advertiser, as the dose in all the studies put forward matched the dose in the product. This is a fatal flaw we often see in such cases: The product has a lower dose than the studied dose. In the case of saffron, the advertiser submitted lots of studies about its use related to cardiovascular disease, depression, anxiety and insomnia – not how Zen-X is intended to be used. After setting these aside, NAD found what we always say you need: just one good study. A four-week, double-blind placebo-controlled study of a good number (121) of healthy individuals who reported low mood, where there was a statistically significant effect shown for tension, mood and vigor. NAD noted there was no washout period reported before the study, and the study authors noted the results relied on individual self-reporting with no objective blood testing for stress levels. But while these are criticisms, NAD found this study provided a reasonable basis overall and supported the claims.
NAD did not credit the studies for the other ingredients. What were some of the fatal flaws there? Some studies were of young males only and thus not representative of the more general target audience. Some studies looked at populations with clinical depression and anxiety, which are not what the product is intended to be used for. Some studies relied on post hoc analysis to get to statistically relevant end points. Some studies were not blinded, which introduced bias. One study NAD set aside because it looked at a one-time dose and not use over time as the product is marketed. In addition, the study was conducted over the pandemic, with its unusual stress conditions. And, of course, NAD set aside the rat studies. (Note to readers: If you feel you need to bring an animal study to NAD to win your case, you are not going to win your case.)
NAD ultimately recommended that if Zen-X wanted to continue making the claim, it must make clear the claim was based on the saffron in the product. I think this was NAD’s way of encouraging the company to convert a product claim into an ingredient claim, which is always key if you haven’t invested in your own product testing. This case is excellent reading for those making any sort of health claim, for the study-by-study breakdown NAD provides. After taking it all in, we think we’ll give this stuff a try, probably washing it down with some wine, and hope we are calm and clearheaded!
