# A thermogenic botanical composition containing Citrus aurantifolia fruit rind and Theobroma cacao seed extracts improves body composition in overweight adults: a clinical investigation

## TL;DR

A new supplement made from citrus and cacao extracts helped overweight adults lose weight and body fat in a 16-week study.

## Contribution

The study demonstrates that a novel botanical extract combination improves body composition in overweight adults.

## Key findings

- CL19183 reduced body weight and BMI significantly compared to placebo.
- The supplement decreased body fat and increased resting metabolic rate.
- Serum biomarkers like adiponectin and glucagon-like peptide-1 improved with CL19183.

## Abstract

CL19183, or Theolim™, is a novel, proprietary combination of standardized extracts of Citrus aurantifolia fruit rind and Theobroma cacao seeds. Earlier, CL19183 supplementation demonstrated thermogenic activity and weight loss in high-fat diet-induced obese rats. This randomized, double-blind, placebo-controlled, multicenter clinical study (RCT) assessed whether CL19183 supplementation reduced body weight (BW) and improved body composition (BC) in overweight adults.

The present study recruited 120 overweight male and female subjects (25–55 years) [body mass index (BMI) of 25–29.9 kg/m2] and randomly assigned to receive daily either CL19183 (450 mg; n = 60) or a matched placebo (n = 60) over 16 weeks. The primary efficacy outcome measure was BW reduction in the intention-to-treat (ITT) population. Other efficacy measures included BC using Dual-energy X-ray absorptiometry (DEXA), waist and hip circumferences, resting metabolic rate (RMR) using indirect calorimetry, serum lipid profile, and serum biomarkers utilizing enzyme-linked immunosorbent assay (ELISA). The safety parameters were performed, including complete serum biochemistry, hematology, and urine analysis.

Post-trial, CL19183 supplementation resulted in significant reductions in BW (4.25 ± 1.35 vs. 0.96 ± 1.18 kg; p = 0.0001; CI [confidence interval]: 1.47, 8.59) and BMI (1.57 ± 0.53 vs 0.36 ± 0.46 kg/m2, p < 0.0001; CI: 0.87, 2.11), from baseline as compared to placebo. Similarly, total body fat (4.28 ± 1.56 vs. 0.85 ± 1.06 kg; p < 0.0001; CI: 2.35, 7.79) and fat percentage (p < 0.0001) were also reduced from baseline in the CL19183 group vs. placebo. At baseline, after a single dose of CL19183 administration and after 16 weeks, RMR was significantly increased (p < 0.0001 vs. placebo). After 8 and 16 weeks of supplementation, CL19183 significantly increased serum adiponectin and glucagon-like peptide-1 and decreased ghrelin levels vs. baseline and placebo. No major adverse events were reported.

CL19183 supplementation was well-tolerated and led to significant BW reduction and improvements in BC over 16 weeks.