Effects of brain-directed nutrients on cerebral blood flow and neuropsychological testing: a randomized, double-blind, placebo-controlled, crossover trial.

CONTEXT

In a prior open trial of professional football players who displayed the effects of traumatic brain injury, the current reserach team reported significant improvements in clinical symptoms, neuropsychological testing and regional cerebral blood flow (rCBF) following the use of brain-directed nutrients (BDNs) and lifestyle interventions.

OBJECTIVE

The current study intended to determine whether supplementation with BDNs improved rCBF and neuropsychological function in healthy individuals.

DESIGN

The current study was a randomized, doubleblind, placebo-controlled, crossover trial, which was a more rigorous reseach design than the prior study and did not include lifestyle interventions.

SETTING

Participants underwent evaluation and testing at the Amen Clinics, Inc, a private medical facility in Newport Beach, CA.

PARTICIPANTS

Thirty healthy adult (15 male and 15 female) participants were recruited from the community though local advertising and met the requirements for eligibility into the study. Twenty-five individuals completed the study, with dropout due to events unrelated to the study itself.

INTERVENTION

The participants were randomly assigned to a treatment order for intervention, either placebo or brain supplements first. The BDNs treatment was comprised of three supplements: fish oil; a high-potency, multiple vitamin/mineral supplement; and a brainenhancement supplement. The placebo treatment was two supplements comprised of rice flour to replace the multiple vitamin/mineral complex and the brain-enhancement supplement and one supplement made of other oils to replace the fish-oil mixture. After 2 mo of this first intervention, a crossover intervention occurred for a final 2 mo, in which participants formerly receiving BDNs received a placebo treatment and participants formerly treated with placebo received the BDNs treatment.

OUTCOME MEASURES

Primary outcome measures included (1) an analysis of the changes in rCBF using SPECT and (2) an assessment of the differences in cognitive and emotional function using the MicroCog (cognitive performance), the WebNeuro (emotional state), and three psychological inventories-the Beck Depression Inventory (BDI-II), Brief Symptom Inventory (BSI), and Quality of Life Inventory (QOLI).

RESULTS

A region of interest (ROI) analysis for each of the 2-mo phases (baseline, then placebo and treatment according to randomized order) showed significant improvement in rCBF for the BDNs as compared to the placebo (as assigned at the start of the first intervention) in the prefrontal cortex, anterior and posterior cingulate gyrus, hippocampus, and cerebellum. Significant improvements were observed for the BDNs (1) on the MicroCog-reasoning, P=.008; memory, P=.014; information processing accuracy, P=.027; (2) on the WebNeuro-executive function, P=.002, information processing efficiency, P=.015; depressed mood, P=.017, and emotional identification, P=.041; and (3) on the BSI-positive symptom total, P=.024 and reduced hostility, P=.018. For the last, significance occurred upon accounting for the effect of order.

CONCLUSION

This study demonstrates the potential effectiveness of BDNs in enhancing rCBF and neuropsychological function across various cognitive and psychological domains.