February 9, 2011
NEW YORKPharmavite LLC supplied evidence that supports claims for its Nature Made GreatMind supplement, reported the National Advertising Division of the Council of Better Business Bureaus, which questioned the claim that the product enhances mental clarity and performance," among others.
According to the advertiser, the product is a cognitive health supplement, based on a formulation developed and studied by Thomas B. Shea, Ph.D., and his colleagues at the University of Massachusetts, Lowell. The formulation has been studied by Dr. Shea and his colleagues in subjects with early, moderate and later-stage Alzheimers disease. Those subjects showed improvement on certain cognitive and dementia rating scales, and formulation was then later studied in healthy subjects using cognitive scales to evaluate the effects.
GreatMind contains vitamin E, folic acid, vitamin B12, N-acetyl-L-cysteine (NAC), acetyl-L-carnitine hydrochloride (ALCAR) and S-adenosylmethionine (SAM-e), in the same formulation as the ingredients used in the studies conducted by Shea and his colleagues, although the amount of vitamin B12 in GreatMind was increased to 12 mcg from 6 mcg.
NAD noted the first Shea study was a double-blind study, with 93 participants who received either placebo or the nutraceutical formulation for three months. The participants, both male and female, ranged from 18 to 80 years old, with no known or suspected dementia or clinical memory difficulties. At three months, the control subjects were switched to the nutraceutical formulation for three months (this group was called the delayed start" group) while the treated subjects continued with the nutraceutical formulation for three more months. At the six-month point, all participants stopped taking the product. At nine months, a small number of the subjects from the trial were re-enlisted to start taking the product again for three more months, resulting in a 12-month total length. The second Shea study was a six-month trial with 38 subjects and no control. The third Shea study was a short-term study with 43 subjects comparing treatment with the nutraceutical formulation to placebo for two weeks, followed by an additional two-week period during which all of the participants were given the nutraceutical formulation.
Following its review of the evidence in the record, NAD concluded that the results of the Shea Studies, which found statistically significant improvement in various measures of cognitive ability in those participants taking GreatMind, provided a reasonable basis for the specific claims about the supplements ability to improve and maintain memory and cognitive ability.
Other claims at issue included:
Keep your mind great with Nature Made GreatMind!"
Naturally helps improve and maintain short-term memory."
Helps guard against normal cognitive decline associated with aging."
Nature Made GreatMind is an easy, natural and effective way to take care of your mind so you can stay clear, sharp and active."
Nature Made GreatMind has a unique, patent-pending formula that enhances mental performance, clarity and short-term memory with daily use."
Nature Made GreatMind is formulated with key ingredients that your mind needs to stay healthy."
Pharmavite believes consumers are best served when advertisers are held to the rigorous standards employed by NAD and appreciates the opportunity to participate in the self-regulatory process," Pharmavite said in its advertisers statement.
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