Safety Evaluation of NutriMeal Products using Animal Model.

Abstract

INTRODUCTION: NutriMeal, a cassava-soya ready-to-use therapeutic food (RUTF), was developed to address severe acute malnutrition (SAM), a global health challenge. It offers a nutrientrich, low-fat alternative to peanut-based RUTFs, which pose aflatoxin risks. This study evaluates NutriMeal's safety through acute and subacute toxicity tests in animal models. METHODOLOGY: Acute toxicity tests involved Swiss albino mice, while subacute tests used male and female Wistar rats. Animals were grouped into dosages (300, 1000, 3000, 5000 mg/kg) and a control. NutriMeal was administered orally once in the acute study, and the animals were observed for 14 days, while the product was administered orally daily for 28 days in the subacute study. Parameters assessed included weight gain, hematological and biochemical markers, organ histopathology, and cyanide levels via high-performance liquid chromatography (HPLC). RESULTS: NutriMeal caused consistent weight gain across groups, reflecting improved nutritional status with no adverse metabolic effects. Hematological and biochemical markers remained within normal ranges, indicating no significant liver or kidney toxicity. The histopathology assessments for the acute and sub-acute toxicity study showed varying responses based on dosage. Histopathology reports were generally normal for the 300mg/kg dose, eight times the recommended dose for children. Also, cyanide levels in NutriMeal and blood samples from treated animals were well below toxic thresholds. CONCLUSION: NutriMeal demonstrated a favorable safety profile in animal models, showing no significant adverse effects even at doses far exceeding human equivalents. These findings support its further evaluation in clinical trials to validate its efficacy and longterm safety in treating SAM.