Effect of Amla extract on Body Mass Index, waist circumference, total body fat, visceral fat, skeletal muscle mass, body age and related parameters: A randomized, open label clinical study in obese participants.

Background: The escalating prevalence and severity of obesity and its associated co-morbidities globally necessitate effective interventions. This randomized open label clinical study aims to assess the efficacy of amla (Emblica officinalis) extract AMX-160 in adult individuals with obesity.

Trial design: This study is a randomized, open-label clinical study conducted at Rajalakshmi hospital, Mangalore. The study adhered to the declaration of Helsinki and ICH-GCP guidelines, with protocol approval from institutional ethics committee and registration with the Clinical Trials Registry-India (CTRI/2019/01/017201). All participants provided written, signed, and dated informed consent before any study-related procedures.

Methods: Forty obese patients were enrolled and divided into two groups. AMX-160 capsules, at doses of 500 mg once daily (AMX-M1) and twice daily (AMX-M2), were administered. Patients were monitored as outpatients for 90 days. Efficacy assessments included anthropometric measurements, Bioelectric Impedance analysis, lipid profile analysis, and the Global Physical Activity Questionnaire (GPAQ) at scheduled visits.

Results: Supplementation with 1 gram of AMX-160 (500 mg twice daily) significantly (p<0.05) reduced visceral fat, increased skeletal muscle mass, and decreased subcutaneous fat. Additionally, it effectively decreased body age and various anthropometric parameters (e.g., waist circumference, waist-to-hip ratio) significantly (p<0.05), along with reducing BMI, body weight, and improving lipid profile (p<0.05). The 500 mg once daily dose also significantly (p<0.05) impacted most parameters. Physical activity levels remained consistent in both groups throughout the study (p>0.05).

Conclusion: The amla extract AMX-160 (Tri-Low®) demonstrated efficacy in reducing subcutaneous and visceral fat, waist circumference, and body age, while increasing skeletal muscle mass. These findings suggest its potential as a supplement for managing obesity and its associated disorders.