Amulya Chadalavada, Yean Kyoung Koo, SukJin Kim, Sudipta Veeramachaneni, Guru Ramanathan, Amulya Yalamanchi
{"title":"含有柑橘果皮和可可树种子提取物的产热植物成分改善超重成年人的身体成分：一项临床研究。","authors":"Amulya Chadalavada, Yean Kyoung Koo, SukJin Kim, Sudipta Veeramachaneni, Guru Ramanathan, Amulya Yalamanchi","doi":"10.29219/fnr.v69.12159","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and objective: </strong>CL19183, or Theolim™, is a novel, proprietary combination of standardized extracts of <i>Citrus aurantifolia</i> fruit rind and <i>Theobroma cacao</i> 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.</p><p><strong>Methods: </strong>The present study recruited 120 overweight male and female subjects (25-55 years) [body mass index (BMI) of 25-29.9 kg/m<sup>2</sup>] and randomly assigned to receive daily either CL19183 (450 mg; <i>n</i> = 60) or a matched placebo (<i>n</i> = 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.</p><p><strong>Results: </strong>Post-trial, CL19183 supplementation resulted in significant reductions in BW (4.25 ± 1.35 vs. 0.96 ± 1.18 kg; <i>p</i> = 0.0001; CI [confidence interval]: 1.47, 8.59) and BMI (1.57 ± 0.53 vs 0.36 ± 0.46 kg/m<sup>2</sup>, <i>p</i> < 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; <i>p</i> < 0.0001; CI: 2.35, 7.79) and fat percentage (<i>p</i> < 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 (<i>p</i> < 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.</p><p><strong>Conclusion: </strong>CL19183 supplementation was well-tolerated and led to significant BW reduction and improvements in BC over 16 weeks.</p>","PeriodicalId":12119,"journal":{"name":"Food & Nutrition Research","volume":"69 ","pages":""},"PeriodicalIF":3.5000,"publicationDate":"2025-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12255159/pdf/","citationCount":"0","resultStr":"{\"title\":\"A thermogenic botanical composition containing <i>Citrus aurantifolia</i> fruit rind and <i>Theobroma cacao</i> seed extracts improves body composition in overweight adults: a clinical investigation.\",\"authors\":\"Amulya Chadalavada, Yean Kyoung Koo, SukJin Kim, Sudipta Veeramachaneni, Guru Ramanathan, Amulya Yalamanchi\",\"doi\":\"10.29219/fnr.v69.12159\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background and objective: </strong>CL19183, or Theolim™, is a novel, proprietary combination of standardized extracts of <i>Citrus aurantifolia</i> fruit rind and <i>Theobroma cacao</i> 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.</p><p><strong>Methods: </strong>The present study recruited 120 overweight male and female subjects (25-55 years) [body mass index (BMI) of 25-29.9 kg/m<sup>2</sup>] and randomly assigned to receive daily either CL19183 (450 mg; <i>n</i> = 60) or a matched placebo (<i>n</i> = 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.</p><p><strong>Results: </strong>Post-trial, CL19183 supplementation resulted in significant reductions in BW (4.25 ± 1.35 vs. 0.96 ± 1.18 kg; <i>p</i> = 0.0001; CI [confidence interval]: 1.47, 8.59) and BMI (1.57 ± 0.53 vs 0.36 ± 0.46 kg/m<sup>2</sup>, <i>p</i> < 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; <i>p</i> < 0.0001; CI: 2.35, 7.79) and fat percentage (<i>p</i> < 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 (<i>p</i> < 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.</p><p><strong>Conclusion: </strong>CL19183 supplementation was well-tolerated and led to significant BW reduction and improvements in BC over 16 weeks.</p>\",\"PeriodicalId\":12119,\"journal\":{\"name\":\"Food & Nutrition Research\",\"volume\":\"69 \",\"pages\":\"\"},\"PeriodicalIF\":3.5000,\"publicationDate\":\"2025-06-24\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12255159/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Food & Nutrition Research\",\"FirstCategoryId\":\"97\",\"ListUrlMain\":\"https://doi.org/10.29219/fnr.v69.12159\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"FOOD SCIENCE & TECHNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Food & Nutrition Research","FirstCategoryId":"97","ListUrlMain":"https://doi.org/10.29219/fnr.v69.12159","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"FOOD SCIENCE & TECHNOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景与目的：CL19183，或Theolim™，是一种新型的专利组合，由柑橘果皮和可可种子的标准化提取物组成。早些时候，CL19183补充剂在高脂肪饮食诱导的肥胖大鼠中显示出产热活性和体重减轻。这项随机、双盲、安慰剂对照、多中心临床研究（RCT）评估了补充CL19183是否能降低超重成年人的体重（BW）和改善身体成分（BC）。方法：本研究招募了120名体重超重的男性和女性受试者（25-55岁）[体重指数（BMI） 25-29.9 kg/m2]，随机分配每天接受CL19183 (450 mg；N = 60)或匹配的安慰剂（N = 60），持续16周。主要疗效指标是意向治疗（ITT）人群的体重降低。其他疗效测量包括双能x线吸收仪（DEXA）的BC、腰臀围、间接量热法的静息代谢率（RMR）、血脂谱和酶联免疫吸附试验（ELISA）的血清生物标志物。安全性参数包括完整的血清生化、血液学和尿液分析。结果：试验后，补充CL19183显著降低了体重(4.25±1.35 vs. 0.96±1.18 kg；P = 0.0001；CI[置信区间]:1.47,8.59)和BMI(1.57±0.53 vs 0.36±0.46 kg/m2, p < 0.0001；CI: 0.87, 2.11)，与安慰剂相比。同样，总体脂(4.28±1.56 vs. 0.85±1.06 kg；P < 0.0001；与安慰剂相比，CL19183组的CI: 2.35, 7.79)和脂肪百分比（p < 0.0001）也较基线降低。在基线时，单剂量CL19183给药后和16周后，RMR显著增加（与安慰剂相比p < 0.0001）。在补充8周和16周后，与基线和安慰剂相比，CL19183显著增加了血清脂联素和胰高血糖素样肽-1，降低了胃饥饿素水平。无重大不良事件报告。结论：补充CL19183具有良好的耐受性，并在16周内显著降低体重和改善BC。
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 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.
期刊介绍：
Food & Nutrition Research is a peer-reviewed journal that presents the latest scientific research in various fields focusing on human nutrition. The journal publishes both quantitative and qualitative research papers.
Through an Open Access publishing model, Food & Nutrition Research opens an important forum for researchers from academic and private arenas to exchange the latest results from research on human nutrition in a broad sense, both original papers and reviews, including:
* Associations and effects of foods and nutrients on health
* Dietary patterns and health
* Molecular nutrition
* Health claims on foods
* Nutrition and cognitive functions
* Nutritional effects of food composition and processing
* Nutrition in developing countries
* Animal and in vitro models with clear relevance for human nutrition
* Nutrition and the Environment
* Food and Nutrition Education
* Nutrition and Economics
Research papers on food chemistry (focus on chemical composition and analysis of foods) are generally not considered eligible, unless the results have a clear impact on human nutrition.
The journal focuses on the different aspects of nutrition for people involved in nutrition research such as Dentists, Dieticians, Medical doctors, Nutritionists, Teachers, Journalists and Manufacturers in the food and pharmaceutical industries.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
