A randomized, double-blinded, placebo-controlled, single-center, comparative study evaluating Phaseolean® safety and efficacy in overweight/obese participants.

Scope: Phaseolean®, a standardized water extract of Phaseolus vulgaris 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. Each group was assigned a specific daily dosage for three meals: Phaseolean® 1500 mg/day (500 mg per meal), Phaseolean® 3000 mg/day (1000 mg per meal), or placebo 1500 mg/day (500 mg per meal), administered thrice a day before meals for 45 consecutive days. Body weight; body mass index (BMI); skinfold fat thickness; waist, hip, and thigh circumferences; and blood biochemical parameters were monitored and analyzed to evaluate the effects of these interventions. Results and conclusions: Of the 66 enrolled participants, 62 completed the study. Treatment with Phaseolean® 1500 mg/day reduced the weight by an average of 2.10 kg (0.33 kg/week), while that with 3000 mg/day was 1.94 kg (0.30 kg/week); 0.13 kg weight loss (0.02 kg/week) was observed in the placebo group after 45 days, showing significant differences between the Phaseolean® and placebo groups (p < 0.01). BMI, body fat, skinfold fat thickness, and the waist, hip, and thigh circumference were significantly reduced (p < 0.01) in both Phaseolean® groups compared with those in the placebo group, which showed no significant changes.No adverse effects were observed during the clinical trial period. Phaseolean® 1500 mg/day dose was more effective in weight reduction than the 3000 mg/day higher dose. Therefore, Phaseolean® can be used to support healthy weight management.

Acute and Subacute Toxicity Assessment of Andrographolide-2-hydroxypropyl-ß-cyclodextrin Complex via Oral and Inhalation Route of Administration in Sprague-Dawley Rats.

Objective: Acute and subacute toxicity analysis of AND-2-HyP-ß-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-ß-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. Correspondingly, single dose acute inhalation toxicity of AND-2-HyP-ß-CYD complex was carried out at 5 mg/L/4 h/day and subacute inhalation toxicity at 0.5, 1, and 1.66 mg/L/4 h/day over a period of 28 days. The NOAEL and LOAEL (lowest observed adverse effect level) were estimated to be 0.5 mg/L/4 h/day and 1 mg/L/4 h/day, respectively. Conclusion: The findings of the present study would further be useful in assessing and utilizing the medicinal and therapeutic benefits of AND-2-HyP-ß-CYD complex.