A Randomized Controlled Trial on the Safety and Cognitive Benefits of a Novel Functional Drink from a Purple Waxy Corn Byproduct in Peri- and Postmenopausal Women.

Fulfilling the demand for functional food with cost safety and environmental sustainability, our novel anthocyanin-enriched functional drink containing the purple waxy corn cob-derived functional ingredient "MP1" showed cognitive enhancing effects with safety in bilaterally ovariectomized rats, a validated model of menopause. Since no clinical evidence that confirms the mentioned effect was available until now, we conducted a two-arm, randomized, double-blind, placebo-controlled, crossover study to confirm the benefits mentioned above. A total of 32 menopausal participants were divided into placebo and MP1 (400 mg) groups, and were subject to a 2-month study period. Safety parameters, working memory and brain components, especially N100 and P300, the negative and positive potentials derived from the event-related potential (ERP) which indicated attention and cognitive processing, together with oxidative stress markers acetylcholinesterase (AChE) and monoamine oxidase (MAO), were assessed at baseline and every month. No serious side effects or toxicity signs were observed. Subjects who consumed MP1 also had decreased N100 and P300 latency, improved working memory and decreased oxidative stress status. Therefore, a byproduct of purple corn can successfully serve as a novel functional ingredient for developing a cognitive enhancer drink with the qualities of safety, cost reduction, and environmental sustainability promotion.