RESUMEN
Aims: We previously demonstrated that a blend of herbal extracts (Weighlevel®; a mixture of extracts from the leaves of Alchemilla vulgaris, Olea europaea, Mentha longifolia and from the seeds of Cuminum cyminum) taken 3 times per day produces weight loss in preclinical and clinical studies. The aim of the present study was to test the efficacy of a new slow-release formulation (Weighlevel® One) taken once per day on change in body weight and related measures. Study Design: Randomized, double-blind, placebo-controlled study. Place and Duration of Study: Health Clinics in Copenhagen, Denmark between 7 January 2016 and 5 March 2016. Methodology: Thirty-six adult subjects were randomized to consume the herbal blend (n = 20) or placebo (n = 16) once per day for 8 weeks. Weight and waist circumference were assessed weekly. The primary endpoint was the change from baseline in body weight for the herbal blend group compared with placebo. Secondary assessments included waist circumference, appetite, craving, bowel health, and safety and tolerability. Results: After 8 weeks, the herbal blend group lost an average of 3.7 kg (95% CI of 3.0 to 4.5 kg); whereas the placebo group lost 0.1 kg (95% CI of -0.7 to 1.0 kg). This difference in mean weight loss between the herbal blend and placebo groups was statistically significant (P <.001). A statistically significant reduction in waist circumference was also observed for the herbal blend compared with placebo (P <.001). The herbal blend was well tolerated; no adverse events were reported. Conclusion: Daily administration of this blend of herbal extracts, administered once daily, may produce weight loss.