Evaluation of Safety of Excessive Intake of Safflower Seed Extract Dietary Supplement in Healthy Adult Subjects

Abstract

To evaluate the safety in humans of a dietary supplement consisting of safflower seed extract (active components: serotonin hydroxycinnamic acid amides), we carried out a high dose administration trial in a placebo-controlled randomized double-blind fashion. Forty healthy subjects, 20 males and 20 females, received 6 capsules of the extract (serotonin derivative aglycones: 210mg/day) or the same amount of placebo diet once a day for 4 weeks. This amount of serotonin derivative aglycones is three times the dose which previously showed significant reduction of vascular age as estimated by a second derivative of photoplethysmogram aging index. The overall results for vital signs and plasma and urine tests in response to the high-dose intake of serotonin derivatives were not-significantly different between the two groups. Although there were some statistically significant changes in the laboratory data, all were clinically insignificant and within physiological ranges. During the supplementation period, some subjective and objective symptoms were reported; however, these were transient and minor, and no significant difference in occurrence was found between the two groups. In conclusion, safflower seed extract dietary supplement is considered to be safe at least up to an intake level of 6 capsules a day for 4 weeks (serotonin derivative aglycones 210mg/day).