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PR release oversells benefit of dietary supplement based on short-term safety trial

First human clinical trial for nicotinamide riboside

Our Review Summary

dietary supplementsThis news release describes a 12-person safety trial of a nicotinamide riboside (NR), a dietary supplement that has been found to boost a coenzyme called nicotinamide adenine dinucleotide (NAD+), which declines in humans as they age. The news release deserves credit for pointing out researchers’ financial conflicts. It also states that there have been no clinical trials to determine whether NR produces any actual health benefits. But that caveat comes after a misleading headline and first paragraph that assert the substance increases levels of a cell metabolite “linked to multiple health benefits” without mentioning these benefits have only been shown to occur in mice. Also, it doesn’t seem fair to characterize this as “new research” as the news release states, since the manufacturer announced these safety findings last year.

[Editor’s note: This review originally noted under the Funding Sources and Conflict of Interest criterion that the release didn’t note funders. That was incorrect and we have revised the commentary in that section.]

 

Why This Matters

NR is being is aggressively marketed under the name Niagen for a variety of health issues including weight loss and age-related conditions, despite a dearth of evidence that it benefits human health. Its manufacturer, ChromaDex, recently announced a deal to expand sales in major retail chains and make it available in consumables such as protein shakes and nutrition bars. It’s also sponsoring research on whether NR can treat two rare disorders, Cockayne syndrome and ataxia telangiectasia, which would open a door to the prescription market. HealthNewsReview.org’s review of a Boston Globe story last year pointed out the need for news stories to cut through the hype over this unproven product. Similarly, a news release that wrongly suggests NR offers health benefits — even if it contains caveats further down — could lead more people to buy it.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

The news release does not discuss costs. A 30-day supply, consisting of 60 125-mg tablets, is available on Amazon for $45.99, or $1.53 per day. There is just one manufacturer — ChromaDex — licensing the patented product to various companies, which package and sell it under their own labels. As a result, there is no real price competition.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

Since there are no proven benefits to humans for NR, there are no benefits to quantify, but that didn’t stop the release from strongly suggesting benefits.

A reader could assume from reading the release that claims of efficacy in humans were being made. For example:

“Vitamin safely boosts levels of important cell metabolite linked to multiple health benefits”

“Because the levels of supplementation in mice that produce beneficial effects are achievable in people, it appears than health benefits of NR will be translatable to humans safely.”

This was a short-term Phase 1 safety trial, which is meant to determine whether a drug is safe by testing it on a small number of people. Phase 2 and 3 trials test a drug’s efficacy as a treatment among larger groups of people.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

No potential harms are addressed. The news release said there were “no serious side effects with any of the doses,” though there were four cases of potential flushing we address under quality of evidence. But it should have pointed out that no safety data exists on long-term use. Nor is there data on the impact of taking this supplement along with other medications or in greater amounts than the tested doses. Also, the people in this study were all healthy, so it’s unclear what impact this substance might have on people with health conditions. That’s an important point since the researchers plan to study NR’s effects on elevated cholesterol, obesity and diabetes as well as people at risk for chemotherapeutic peripheral neuropathy.  Also, just because something occurs naturally in the human body doesn’t mean it’s safe.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The news release makes it clear that this is a safety trial involving just 12 healthy people but does not give the length of time for which they were observed — 36 days. That’s important because many people take dietary supplements for months or years. The news release also doesn’t mention that further research is needed to assess whether NR is associated with episodes of flushing, in which dilated blood vessels create a sensation of warmth. In this study, four patients reported flushing or feeling hot.

Does the news release commit disease-mongering?

Satisfactory

The news release does not engage in outright disease mongering. However, its statement that a natural loss of NAD+ over time “may play a role in age-related health decline” implies that aging is a condition that needs to be treated.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

The news release lists the funders and states that the manufacturer, ChromaDex, supplied NR for use in the trial and that lead researcher, Charles Brenner, is a consultant for ChromaDex and co-counder and chief scientific advisor of ProHealthspan, which sells NR supplements under the trade name Tru NIAGEN.

The release does not state that Brenner has other conflicts including owning stock in ChromaDex, or that four of the other nine researchers have financial conflicts.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

The news release states that researchers found NR is “superior” to two other NAD+-boosting vitamins, niacin and nicotinamide, in the total amount of NAD+ produced and stimulation of sirtuin enzymes, which influence a cellular processes such as energy efficiency, inflammation, stress resistance, and mitochondrial biogenesis. However, it’s impossible to say at this point whether any of these biochemical effects translate into health benefits.

The news release does not mention any proven methods for boosting metabolism and maintaining health into old age, such as keeping active and maintaining a good diet.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

The news release states that the supplements are commercially available.

Does the news release establish the true novelty of the approach?

Not Satisfactory

The news release calls this “new research.” However, last year NR maker ChromaDex issued a news release stating that “initial results” of the trial of NR in humans showed it is safe and increases the NAD+ coenzyme. So apparently this isn’t entirely news. It seems that the real news is that the study results were published in the journal Nature Communications.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

The release overall has a measured tone and avoids exaggeration and sensationalism, except for some troublesome phrases that have already been addressed under the Benefits criterion.  In particular, the headline states that NR “safely boosts levels of important cell metabolite linked to multiple health benefits.” The lead echoes that NR “increases levels of a cell metabolite that is critical for cellular energy production and protection against stress and DNA damage.” Those statements imply benefits that are not proven to exist.

Total Score: 4 of 10 Satisfactory

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