Jerusalem artichoke extract as a functional ingredient in margarine: physicochemical properties, stability, microbiological, and toxicological assessment

Margarine was developed as a cheaper and shelf-stable alternative to butter. However, health concerns have driven drastic reformulations over the years, with its composition continuously evolving to reduce potentially harmful ingredients while incorporating healthier alternatives. This study investigates the development of potentially healthier margarine formulations enriched with inulin rich water extract of Jerusalem artichoke (WEJA). Inulin has well-documented prebiotic benefits through its resistance to upper gastrointestinal digestion and subsequent fermentation by beneficial gut microbiota. We evaluated three WEJA-enriched margarines (WEJAM-1, WEJAM-2, WEJAM-3) containing increasing inulin concentrations in the water phase (11.6%, 23.4%, and 35.6%, respectively) against a conventional control formulation. Assessments of physicochemical properties, emulsion stability, and oxidative stability over a 12-month storage period were conducted on all margarines. Among all the samples, only WEJAM-2 satisfied the requirements specified in national standard O'zDSt 3317-2018, thus it was selected for patenting leading to an eventual commercialization. Following the patenting of WEJAM-2 (Patent No. IAP 07408), mandatory toxicological evaluation was conducted in accordance with Uzbek regulatory standards, encompassing sensitizing properties, mucous membrane irritation potential, oral median lethal dose determination, and cumulative effects assessments using laboratory animal models. Additionally, microbiological analyses confirmed the absence of pathogenic microorganisms and full compliance with established food safety requirements. Comprehensive toxicological investigations revealed no adverse effects, with WEJAM-2 classified as a low-risk substance (IV hazard class). The 28-day subchronic toxicity study demonstrated no significant alterations in biochemical parameters, hematological indices, or organ histology. These findings collectively substantiate that WEJAM-2 margarine meets rigorous food safety requirements while offering potential health benefits through its inulin enrichment.