NAD found Pharmavite’s Nature Made GreatMind possessed sufficient scientific backing to make claims such as “Enhances mental clarity and performance”; “Helps guard against normal cognitive decline associated with aging” and “Naturally helps improve and maintain short-term memory”.
The claims appear online and in labelling for the product that contains vitamin E, folic acid, vitamin B12, N-acetyl-L-cysteine (NAC), acetyl-L-carnitine hydrochloride (ALCAR) and S-adenosylmethionine (SAM-e).
The formulation had been used in three studies conducted by Thomas Shea, PhD, at the University of Massachusetts although with 12mcg doses of B12 rather than the 6mcg contained in GreatMind.
Subjects with early, moderate and later-stage Alzheimer’s disease were used.
“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 supplement’s ability to improve and maintain memory and cognitive ability,” NAD concluded.
It added: “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.”
Shea’s studies included a double-blind study, with 93 participants; a six-month trial with the 38 subjects and no control and a two-week study with 43 subjects that compared treatment with the nutraceutical formulation to placebo.
The biggest study involved 18 to 80-year-olds with no known or suspected dementia or clinical memory difficulties, with control and treatment groups given either placebo or GreatMind at different times over a 12-month period.
“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.