This pilot study is a very important milestone. To achieve statistical significance in key cognitive markers with a study population of this size is very encouraging, and we eagerly look forward to the results of the larger study currently underway.
Austin, Texas (PRWEB) February 14, 2014
Results from a pilot study entitled “A Proof of Concept Study for a Randomized Double-Blind, Placebo Controlled, Parallel Group, Efficacy Study of Alpha BRAIN™ Administered Orally,” conducted by the Boston Center for Memory will be presented at the annual International Neuropsychological Society (INS) meeting in Seattle, February 12th-15th.
To download a PDF of the poster, click here or visit https://www.onnit.com/clinical-studies/alpha-brain-clinical-trial/.
The purpose of the study was to test the efficacy of the Alpha BRAIN™ as well as devise a logical design for the future of testing products aimed at cognitive enhancement. Specific cognitive areas that were evaluated during the study included memory, attention and executive functioning as well as Alpha BRAIN™ effect on sleep.
The study followed a randomized, double-blind design and included a placebo run-in for all subjects in order to minimize any potential placebo effect. During the study, seventeen cognitively healthy subjects were randomized to receive a six-week supplementation of either Alpha BRAIN™ or a placebo. Prior to starting study treatment, each subject underwent a battery of neuropsychological tests to assess cognitive functioning. After six-weeks of following the manufacturer's recommended dose of either Alpha BRAIN™ or placebo, the neuropsychological testing battery was repeated.
Lead researcher Todd M. Solomon, PhD, who will be presenting the data at the INS conference, commented, “We feel this is a great example of how the same rigorous methodology and design used in experimental medication trials can be applied to research involving supplements. While the number of subjects in this pilot study is too small to allow for extrapolation of the results, we are excited to apply this design to a larger study."
Results from the pilot study demonstrated that overall compliance with study treatment was excellent. Further, both study treatment and placebo were well tolerated. With regard to cognitive outcome measures, results indicated that following the six-week study period, the control group neither significantly improved nor deteriorated on neuropsychological measures. Of the sixteen neuropsychological tests included in the analysis, the group receiving Alpha BRAIN™ showed statistically significant improvement on two of the outcome measures in areas that relate to verbal memory and executive function. While the small sample size limits the generalizability of this study, the findings are highly encouraging and a larger study, currently underway, will include more subjects and utilize unique biomarkers to provide greater insight to the effects of Alpha BRAIN™ on healthy individuals.
Aubrey Marcus, CEO of Onnit commented further. “We are learning that the clinical trial process requires a great deal of patience, but Onnit remains committed to marrying the best earth grown ingredients formulas, to the most rigorous scientific analysis. This pilot study is a very important milestone. To achieve statistical significance in key cognitive markers with a study population of this size is very encouraging, and we eagerly look forward to the results of the larger study currently underway.”
Onnit also expects to present separate data from a full clinical trial on the T+ formulation later in the spring. Results for the larger Alpha BRAIN™ trial are expected in 2015.
For scientific or medical inquiry contact Jarrett Leech, Jarrett(at)Onnit(dot)com.
For general press, or sales inquiry contact Orlando Rios, Orlando(at)Onnit(dot)com.
Onnit is an Austin, TX based health and wellness company focused on encouraging peak performance through a combination of unique products and actionable information. With strategy from leading professional athletes and medical practitioners, Onnit has focused on creating naturally derived nutritional supplements and functional foods based upon the latest ingredient science and dietary research. Their flagship nootropic, AlphaBRAIN™, is designed to help the body foster optimal brain function with a combination of neuro-specific antioxidants and neurotransmitter precursors. Other formulas for mood, athletic endurance, immune health, and testosterone round out their list of acclaimed formulations. Valuing the importance of the body as well as the mind, Onnit offers functional fitness equipment designed to enhance real world strength and endurance--The final piece on the roadmap to Total Human Optimization.