Scope: Phaseolean®, a standardized water extract of or white kidney bean, exhibits α-amylase inhibitory property, which decreases calorie absorption by preventing or delaying carbohydrate digestion, thus supporting weight management. This randomized, double-blind, placebo-controlled, single-center comparative study (Clinical trial registration number: CTRI/2023/02/049440, Registered on: February 03, 2023) evaluated the safety and efficacy of Phaseolean® in weight management in overweight or obese participants upon regular intake at two different doses compared with placebo.
Method: Sixty-six participants were enrolled and randomly divided into three groups, considering the inclusion & exclusion criteria.
Objective: Acute and subacute toxicity analysis of AND-2-HyP--CYD complex was conducted in Sprague-Dawley (SD) rats following oral and inhalation routes of administration.
Methods And Results: Single dose acute toxicity was carried out at 2000 mg/kg of AND-2-HyP--CYD complex, while the doses of 200, 400, and 666 mg/kg were administered, over a period of 28 days under repeated dose oral toxicity study. Hence, LD50 (lethal dose) was found to be >2000 mg/kg in addition to NOAEL (no observed adverse effect level) of 666 mg/kg.