MIRACLE SEED

The widespread use of herbal supplements in Sub-Saharan Africa has created an urgent need for safety evaluation of commercially available polyherbal formulations. Miracle Seed Ultima® (MSU) is a popular liquid extract marketed for immune enhancement, fertility improvement, and metabolic regulation, yet it lacks comprehensive toxicological data to support its safety claims. This study investigated the acute and subacute toxicity profile of MSU in male albino Wistar rats to establish its safety. The acute toxicity assessment was conducted using the Lorke method, which involved administering MSU at doses ranging from 10 mg/kg to 5000 mg/kg. Animals were observed for 14 days for mortality, behavioral changes, and clinical signs of toxicity. The subacute toxicity study followed OECD guideline 407, where rats received daily oral doses of 100 mg/kg, 300 mg/kg, and 1000 mg/kg for 28 days. Body weight, food consumption, and clinical signs were monitored throughout the study period. Blood samples were collected for hematological analysis and biochemical assessment of liver function (ALT, AST, ALP, total protein, albumin, bilirubin), kidney function (urea, creatinine, electrolytes), lipid profile (total cholesterol, triglycerides, LDL, HDL, VLDL), and fasting blood glucose. Phytochemical analysis identified high concentrations of cardiac glycosides (310.59 ± 2.36 mg/g), steroids (174.22 ± 5.01 mg/g), flavonoids (151.82 ± 3.58 mg/g), coumarins (113.27 ± 4.81 mg/g), and alkaloids (93.81 ± 7.86 mg/g). Elemental analysis indicated high levels of calcium (6,304.00 ± 2.08 mg/kg), potassium (5,252.33 ± 1.20 mg/kg), and magnesium (3,704.67 ± 2.40 mg/kg), with no detectable levels of lead or cadmium, suggesting low contamination risk. In vitro antioxidant tests showed moderate DPPH radical scavenging at 55.77 ± 3.67% and FRAP reducing activity at 51.95 ± 1.31%, with notably strong nitric oxide scavenging at 88.15 ± 2.21%, comparable to ascorbic acid (92.38 ± 0.41%). Acute toxicity tests at doses up to 5,000 mg/kg showed no mortality or clinical signs over 14 days, classifying MSU as practically non-toxic (LD50 > 5,000 mg/kg). However, kidney cysts were observed in some animals at higher doses. Subacute exposure (100, 300, 1,000 mg/kg/day for 28 days) revealed dose-dependent hepatocellular stress, with elevated serum ALT at 300 mg/kg (135.00 ± 8.70 U/L) and 1,000 mg/kg (200.56 ± 22.20 U/L). Conversely, kidney function improved, with decreased plasma urea at 1,000 mg/kg (68.62 ± 2.90 mg/dL) versus control (102.72 ± 5.70 mg/dL), suggesting nephroprotective effects. All hematological parameters and metabolic markers remained normal, indicating a No Observed Adverse Effect Level (NOAEL) of 100 mg/kg/day. This study provides the first comprehensive toxicological evaluation of Miracle Seed Ultima®, demonstrating that the formulation has acceptable safety at moderate doses but may cause mild liver stress at higher doses. The findings suggest that MSU can be safely used at doses up to 100 mg/kg, but long-term users should undergo periodic liver function monitoring, particularly those with pre-existing liver conditions. These results provide essential baseline data to inform regulatory decisions, guide clinical use, and protect consumer safety while supporting the continued use of this traditional herbal formulation.

Miracle Seed Ultima® (MSU) is widely used as a natural supplement, yet scientific evidence on its safety profile remains limited. This study therefore evaluated the sub-acute toxicity effects of MSU on liver function and lipid metabolism in male Wistar rats. Twenty rats were randomly assigned to four groups and administered 0 mg/kg (control), 100 mg/kg, 300 mg/kg, and 1000 mg/kg of MSU orally for 28 days. Liver biomarkers including ALT, AST, ALP, total protein, albumin, total bilirubin, and direct bilirubin were analysed, while lipid profile parameters (total cholesterol, triglycerides, HDL, LDL, and VLDL) were assessed.The results showed no statistically significant differences (P > 0.05) in AST, ALP, total bilirubin, direct bilirubin, or albumin levels across all doses. However, ALT increased significantly (P < 0.05) in the 300 mg/kg and 1000 mg/kg groups compared with the control, with mean values of 147.35 ± 12.9ᵃ (control), 135.00 ± 8.7ᵃᵇᵈ (300 mg/kg), and 200.56 ± 22.2ᵃᶜᵉ (1000 mg/kg), indicating a dose-related biochemical change. Total protein decreased significantly in the 100 mg/kg group 4.06 ± 0.1ᵃ (control) and 3.39 ± 0.1ᵇᶜ(100mg/kg), although values remained within physiological ranges. Lipid parameters showed no statistically significant alterations, indicating that the observed slight increase in total cholesterol in Group 3 and reduced triglycerides in Group 2 were not biologically meaningful since they were not statistically supported.Overall, the findings indicate that MSU did not produce broad hepatic or lipid toxicity within the 28-day period. Although ALT increased at higher doses, a single enzyme elevation without corresponding changes in other hepatic markers does not conclusively indicate liver damage. Nevertheless, the dose-dependent rise suggests a potential early biochemical response that warrants further attention. The study highlights the need for additional investigations involving histopathology, oxidative stress markers, and long-term exposure to more conclusively establish the safety profile of MSU