Department of Biomedicinal Research, R&D Center for Excellence, Vidya Herbs Pvt Ltd, No. 14/A, KIADB, Jigani Industrial Area, Anekal Taluk, Bangalore, Karnataka, 560105, India.
Anand Multispeciality Hospital, Gorwa, Vadodara, Gujarat, 390016, India.
BMC Complement Med Ther. 2024 May 21;24(1):197. doi: 10.1186/s12906-024-04487-1.
Rosa species are rich sources of polyphenols with physiological functions. In this study a polyphenol-rich Rosa multiflora (var. platyphylala) petal extract (RoseFit™) was investigated for weight loss in humans.
In a randomized, placebo-controlled, parallel-group, double-blind clinical trial seventy overweight male and female subjects (20-50 years) with body mass index (BMI) 25-30 kg/m were randomly allocated to the active treatment group (RoseFit) and placebo group in a 1:1 ratio. The subjects received 300 mg capsules twice daily for 12 weeks. The primary efficacy outcome measures included body weight, BMI, and body composition, as determined using Dual-energy X-ray absorptiometry (DEXA). Secondary measures consisted of serum lipid profile and appetite marker (leptin and ghrelin) analyses. Safety analyses included biochemical and hematological assessments.
At the end of the study, a marked reduction in body weight (-1.20 ± 2.62 kg, p < 0.05) and BMI from baseline was observed in the RoseFit group. In addition, the body fat % (RoseFit = -1.69 ± 2.59%, placebo = 0.96 ± 3.21%; p < 0.001) and fat mass (RoseFit = -1.75 ± 1.80 kg, placebo = 1.61 ± 3.82 kg; p < 0.001) were significantly abated in RoseFit group. Importantly, the lean mass was maintained during the intervention. RoseFit ingestion significantly increased the serum leptin levels compared to the placebo (4.85%; p < 0.05). Further, RoseFit group showed reduction in the hunger hormone ghrelin level (2.27%; p < 0.001) from baseline to the end of study, compared to the placebo. The subjective evaluation of appetite using visual analog scale (VAS) questionnaires further confirmed the appetite-suppression effects of RoseFit. The lipid profile significantly improved in RoseFit-treated subjects. No serious adverse events were observed during the study, indicating the tolerability of RoseFit.
Supplementation with RoseFit significantly impacts body weight management and can thus be a potential nutraceutical ingredient for sustainable weight loss.
CTRI/2019/10/021584 dated 09/10/2019.
蔷薇属植物富含具有生理功能的多酚。本研究以富含多酚的多花蔷薇（变种）花瓣提取物（RoseFit™）为研究对象，探讨其在人体减肥方面的作用。
采用随机、安慰剂对照、平行分组、双盲临床试验，将 70 名超重的男性和女性受试者（20-50 岁），体重指数（BMI）为 25-30kg/m²，按 1:1 的比例随机分为活性治疗组（RoseFit）和安慰剂组。受试者每日服用 300mg 胶囊 2 次，持续 12 周。主要疗效终点包括体重、BMI 和体成分，采用双能 X 射线吸收法（DEXA）测定。次要终点包括血清血脂谱和食欲标志物（瘦素和胃饥饿素）分析。安全性分析包括生化和血液学评估。
研究结束时，RoseFit 组体重（-1.20±2.62kg，p<0.05）和 BMI 均明显下降。此外，RoseFit 组体脂百分比（-1.69±2.59%，安慰剂组=0.96±3.21%；p<0.001）和脂肪量（-1.75±1.80kg，安慰剂组=1.61±3.82kg；p<0.001）也显著减少。重要的是，干预期间瘦体重保持不变。与安慰剂相比，RoseFit 摄入显著增加了血清瘦素水平（4.85%；p<0.05）。此外，与安慰剂相比，RoseFit 组的饥饿激素胃饥饿素水平在研究结束时降低了 2.27%（p<0.001）。使用视觉模拟量表（VAS）问卷对食欲进行的主观评估进一步证实了 RoseFit 的抑制食欲作用。RoseFit 治疗组的血脂谱显著改善。研究过程中未观察到严重不良事件，表明 RoseFit 具有良好的耐受性。
补充 RoseFit 可显著影响体重管理，因此可能成为可持续减肥的潜在营养成分。
CTRI/2019/10/021584，日期为 2019 年 10 月 9 日。
