Prospective observational study to assess the effectiveness and tolerability of L-Carnitine Tartrate in obese adults for weight loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean absolute and percent change in body weight from baseline to follow-up (measured using digital weighing scale)
研究概览
简要总结
This is a single-centre, prospective, observational study designed to evaluate the effectiveness and tolerability of Fast&Up Lean Body (L-Carnitine Tartrate 1000 mg) in obese adults with a BMI between 25–35 kg/m².
Participants will receive 2 effervescent tablets (2000 mg L-Carnitine Tartrate) daily, dissolved in water and taken 30 minutes before physical activity, for 8 weeks.
The primary outcome is the mean absolute and percent change in body weight from baseline to follow-up visits. The secondary outcomes include changes in BMI, waist–hip ratio, waist and hip circumference, lean body mass, visceral fat, body fat %, skeletal muscle %, metabolic parameters (assessed using bioelectrical impedance analysis), quality of life (RAND SF-36 questionnaire), patient and physician global satisfaction, treatment adherence, and adverse events.
A total of 50 participants will be enrolled at one site. Data will be analyzed using descriptive statistics, chi-square tests for categorical variables, and ANOVA for continuous variables.
The study will be conducted in compliance with the Declaration of Helsinki, ICH-GCP, Indian GCP, and ICMR guidelines. Written informed consent will be obtained from all participants.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 21.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adults aged 21–65 years (men or women) 2.BMI 25–35 kg/m² 3.Newly initiated on Fast&Up Lean Body 4.Willing to follow physician-recommended lifestyle/diet/exercise advice 5.Willing to comply with product intake and follow-up visits 6.Willing to provide informed consent.
排除标准
- •1.Pregnant or lactating women 2.Known hypersensitivity to L-Carnitine Tartrate or excipients 3.Severe hepatic dysfunction, severe renal impairment, or hypertension 4.Obesity due to hormonal conditions (e.g., hypothyroidism, PCOS, T2DM) 5.Use of weight-reducing supplements/medications, hormonal therapy, pre/pro/synbiotics, multivitamins, antacids, antibiotics, steroids, laxatives within last 2 months 6.Participation in another interventional clinical trial for weight loss 7.Current or recent (within 3 months) treatment diet.
结局指标
主要结局
Mean absolute and percent change in body weight from baseline to follow-up (measured using digital weighing scale)
时间窗: Baseline to follow-up
次要结局
- 1.Change in BMI, waist-hip ratio, waist and hip circumference(2.Lean body mass, visceral fat, body fat %, skeletal muscle %, bone mass, metabolism, protein %, obesity degree %, body age (via BIA – Omron Karada Scan))
研究者
Dr Vivek Redkar
Redkar Hospital & Research Centre