A 90-day oral toxicity study of Grains of Paradise Extract

Grains of Paradise (Aframomum melegueta [Roscoe] K. Schum.), a spice native to West Africa, has a rich ethnopharmacological history. Studies suggest Grains of Paradise possesses anti-inflammatory and analgesic properties. However, despite these potential therapeutic uses, comprehensive toxicological data on the extract of Grains of Paradise in animals remains limited. This study aimed to evaluate the subchronic toxicity of Grains of Paradise Extract in Sprague Dawley rats following 90 days of oral administration by gavage at doses of 0 (vehicle control), 135, 270, and 340 mg/kg bw/day, followed by a 28-day recovery period for the high-dose and control groups. No mortality, adverse clinical signs, or treatment-related differences in body weight, organ weights, and feed consumption were observed. Hematology, clinical chemistry, and histopathology did not reveal toxicologically significant changes. While some statistically significant, non-dose-dependent alterations occurred, such as minor T3/T4 elevations at 340 mg/kg, these lacked toxicological relevance without thyroid dysfunction. Based on the overall data, the No Observed Adverse Effect Level (NOAEL) for Grains of Paradise Extract was determined to be 270 mg/kg bw/day. These results support the long-term safety of this botanical, facilitating its potential application as a functional food or therapeutic.