Health Claims, Berry Benefits

& Clinical Trials

Part 2 of 2

 

 

[follow the Wikipedia links]

Three recent essays from the Berry Doctor's Journal presented research on the potential health effects of having berries in the diet

bone health

anti-aging

inflammation and pain prevention

There are many other possible benefits of having an antioxidant-rich diet through consumption of berries and other pigmented plant foods

included in the 5 a Day Way

However....

limited clinical studies* exist on the health benefits of berries or berry juice, despite a growing popular following based sparingly on science but mainly on a large amount of tradition, lore, appealing taste and effective marketing.

[* Since 2004, cranberries have an allowable claim in France for reducing the incidence of

urinary tract infections from multiple continuous months of juice consumption]

As consumers, we need to be cautious about what is stated on product labels.

What guidelines should we follow? Whom do we trust?

Black chokeberries, Aronia melanocarpa

Experts agree that a “claim is valid based on the totality of publicly available scientific evidence, including evidence from well-designed studies conducted in a manner consistent with generally recognized procedures and principles.”

The standard of scientific validity for a health claim includes two components:

1) that the total publicly available evidence supports the substance vs. disease relationship that is the subject of the claim, and

2) that there is significant scientific agreement among qualified experts that the relationship is valid.

In short: a specific anti-disease effect confirmed by experts

How do experts become convinced about anti-disease effects?

Clinical trials (click!) -- read the Wikipedia link for background

 

Value of Clinical Trials

Let’s discuss briefly why food and medical research needs the clinical trial system to establish human evidence about nutrients and health.

Three main factors of a clinical trial that lead to acceptance of facts from nutritional research are

  • that a large number of people, perhaps hundreds or even thousands, have served as subjects, this number representing an even larger population segment (millions of users of the food under study),
  • that the design of the trial, especially its control of dietary or pharmaceutical factors that would influence or disguise the desired result, have been well controlled, and
  • that the results and interpretation of the data have been assessed objectively and reviewed rigorously by other experts (“peers”) before publication.

In simple terms, sponsors of a food clinical trial must create a

project founded on scientific evidence.

Particularly, the Institute of Food Technologists report (part 1) suggests that the scientific evidence be constructed from

1) epidemiological studies (large-scale observational data associating foods with anti-disease effetcs)

2) biological mechanisms revealed from chemical, cellular or animal models

3) intervention clinical trials of a food on a well-controlled sample of human users.

More on clinical trials from the American Cancer Society (click!)

 

Cranberries, Vaccinium macrocarpon

Courtesy of The Cranberry Institute

Often, clinical trial results are reported for small groups of people studied for a specific biological effect, e.g., this one of only 42 normal people testing a

flavonoid from green tea to determine changes in blood flow.

Most scientists would say, however, that such a study is not a clinical trial, but rather merely a pilot study (initial probe to identify an effect) because there are

too few subjects in the study and insufficient control of variables

that could influence the result.

[If you're very interested in the makeup of a clinical trial,

read this site from the US National Institutes of Health (click)]

 

Has any berry product met sufficient conditions to be

entered into a clinical trial ?

Except for the cranberry studies accepted in France (see part 1), No!

Berry research is still at an early stage and product sponsors have not been willing to invest in the considerable expenses of time and funds to conduct acceptable clinical trials.

The FDA's list of qualified health claims allows favorable statements for tomatoes, walnuts, canola and olive oil, green tea, and others (click)

 

Conclusion:

Specific health claims for berries are not yet established with sufficient scientific evidence.

For any berry excepting the cranberry, specific health claims on product labels or in marketing literature are not yet permitted.

If seen on berry product labels, such claims are considered fraud --

see the FDA web page for fraud among food health claims

and the popular Tip-Offs to Rip-Offs page!

 

Next!

In the northern hemisphere, we're in the final stages of

fruit development for strawberry season -- the first berry crop of the year.

We'll look at some of the recent research on the world's most popular berry!

 

Archives (click!)

 

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Dr. Paul
The Berry Doctor