A thermogenic botanical composition containing Citrus aurantifolia fruit rind and Theobroma cacao seed extracts improves body composition in overweight adults: a clinical investigation
Background and objective: 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 rando...
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Swedish Nutrition Foundation
2025-06-01
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| Series: | Food & Nutrition Research |
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| Online Access: | https://foodandnutritionresearch.net/index.php/fnr/article/view/12159/19643 |
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| author | Amulya Chadalavada Yean Kyoung Koo SukJin Kim Sudipta Veeramachaneni Guru Ramanathan Amulya Yalamanchi |
| author_facet | Amulya Chadalavada Yean Kyoung Koo SukJin Kim Sudipta Veeramachaneni Guru Ramanathan Amulya Yalamanchi |
| author_sort | Amulya Chadalavada |
| collection | DOAJ |
| description | Background and objective: 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. Methods: 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. Results: 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. Conclusion: CL19183 supplementation was well-tolerated and led to significant BW reduction and improvements in BC over 16 weeks. |
| format | Article |
| id | doaj-art-e3cd63536c6d4d658294b0060eb17433 |
| institution | DOAJ |
| issn | 1654-661X |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Swedish Nutrition Foundation |
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| series | Food & Nutrition Research |
| spelling | doaj-art-e3cd63536c6d4d658294b0060eb174332025-08-20T03:17:08ZengSwedish Nutrition FoundationFood & Nutrition Research1654-661X2025-06-0169011410.29219/fnr.v69.1215912159A thermogenic botanical composition containing Citrus aurantifolia fruit rind and Theobroma cacao seed extracts improves body composition in overweight adults: a clinical investigationAmulya Chadalavada0Yean Kyoung Koo1SukJin Kim2Sudipta Veeramachaneni3Guru Ramanathan4Amulya Yalamanchi5Department of General Medicine, Aditya Multi Speciality Hospital, Guntur, IndiaDepartment of R&I Center, COSMAXBIO, Seongnam, Republic of KoreaDepartment of R&I Center, COSMAXBIO, Seongnam, Republic of KoreaSV Scientific, One PPG Place, Suite 3300, Pittsburgh, PA, USAPharmacology-Based Clinical Trials Laboratory, Pennington Biomedical Research Center, Baton Rouge, LA, USADepartment of General Medicine, Yalamanchi Hospitals and Research Centre, Vijayawada, IndiaBackground and objective: 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. Methods: 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. Results: 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. Conclusion: CL19183 supplementation was well-tolerated and led to significant BW reduction and improvements in BC over 16 weeks.https://foodandnutritionresearch.net/index.php/fnr/article/view/12159/19643body compositionglucagon-like peptide-1resting metabolic ratetheolim™thermogenic botanical combination |
| spellingShingle | Amulya Chadalavada Yean Kyoung Koo SukJin Kim Sudipta Veeramachaneni Guru Ramanathan Amulya Yalamanchi A thermogenic botanical composition containing Citrus aurantifolia fruit rind and Theobroma cacao seed extracts improves body composition in overweight adults: a clinical investigation Food & Nutrition Research body composition glucagon-like peptide-1 resting metabolic rate theolim™ thermogenic botanical combination |
| title | A thermogenic botanical composition containing Citrus aurantifolia fruit rind and Theobroma cacao seed extracts improves body composition in overweight adults: a clinical investigation |
| title_full | A thermogenic botanical composition containing Citrus aurantifolia fruit rind and Theobroma cacao seed extracts improves body composition in overweight adults: a clinical investigation |
| title_fullStr | A thermogenic botanical composition containing Citrus aurantifolia fruit rind and Theobroma cacao seed extracts improves body composition in overweight adults: a clinical investigation |
| title_full_unstemmed | A thermogenic botanical composition containing Citrus aurantifolia fruit rind and Theobroma cacao seed extracts improves body composition in overweight adults: a clinical investigation |
| title_short | A thermogenic botanical composition containing Citrus aurantifolia fruit rind and Theobroma cacao seed extracts improves body composition in overweight adults: a clinical investigation |
| title_sort | thermogenic botanical composition containing citrus aurantifolia fruit rind and theobroma cacao seed extracts improves body composition in overweight adults a clinical investigation |
| topic | body composition glucagon-like peptide-1 resting metabolic rate theolim™ thermogenic botanical combination |
| url | https://foodandnutritionresearch.net/index.php/fnr/article/view/12159/19643 |
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