A randomized, double-blind, placebo-controlled, parallel group, single center clinical trial to assess the efficacy and safety of vine tea extract versus placebo for body fat loss in overweight subjects
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
Obesity is a highly prevalent non-communicable disease with significant public health implications. Obesity has been recognized since ancient times, but over time, it has been interpreted varyingly depending on the science and society of the period. Obesity is described as a “multi-metabolic and hormonal disease state.” The increasing prevalence of obesity is a global health concern due to its association with higher risks of cardiovascular diseases, diabetes, and cancers. The interaction between global food systems and local environmental and genetic factors leads to significant variation in obesity prevalence across populations. In low-income countries, obesity primarily affects middle-aged adults, while in high-income countries, it affects both sexes and all age groups. The rise in obesity rates imposes a substantial health and economic burden worldwide. Projections suggest that by 2030, overweight and obesity rates will reach 89% in males and 85% in females, leading to significant increases in the prevalence of coronary heart disease, cancers, and type 2 diabetes, and escalating healthcare costs.
Vine tea extract contains multiple natural flavonoids with a wide range of biological effects on different tissues in the body. It has been extensively researched for its potential in the treatment of various conditions. Additionally, vine tea extract has demonstrated potential as a weight lowering agent in laboratory animals. The present study is designed to evaluate the efficacy and safety of vine tea extract in individuals who are mildly overweight with the study title—“ A randomized, double-blind, placebo-controlled, parallel group, single center clinical trial to assess the efficacy and safety of vine tea extract versus placebo for body fat loss in overweight subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects aged between 18 and 60 years.
- •Body mass index BMI ranging between 25 to
- •Subjects failing to control their body weight through diet therapy alone.
- •Subjects willing to follow the medication diet and exercise requirements as determined by the investigators.
- •Subjects with stable body weight patient reported body weight change less than 5 kg in the last 3 months.
- •Capacity and willingness to provide written informed consent and adhere to the study protocols.
排除标准
- •Subjects who have received any medications or dietary supplements for weight reduction or management within 1 month prior to screening.
- •Subjects who have received GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors, or insulin therapy within 3 months prior to screening.
- •Subjects who are pregnant, intending to become pregnant during the study period or are lactating.
- •Subjects who are participating in any rigorous exercise programs.
- •Subjects with a history of substance abuse including drugs and alcohol.
- •Subjects with type 1 diabetes or secondary diabetes.
- •Subjects with fasting blood glucose levels greater than 126 mgdL or who are currently on any antidiabetic medications.
- •Subjects with acute metabolic complications, such as diabetic ketoacidosis or hyperglycemic coma, within 6 months before screening.
- •Subjects with obesity caused by endocrine diseases, such as Cushings syndrome.
- •Subjects with abnormal thyroid-stimulating hormone (TSH) levels.
- •Subjects with a past or family history of medullary thyroid carcinoma (MTC) (grandparents, parents, siblings) or multiple endocrine neoplasia type 2 (MEN2).
- •Subjects with a history of pancreatic cancer or acute or chronic pancreatitis, or with acute or chronic pancreatitis at the time of screening.
- •Subjects with acute gallbladder disease (e.g., cholecystitis, gallstones) more than twice in the 1 year before screening.
- •Subjects with severe gastrointestinal disorders affecting food intake.
- •Subjects with medical conditions known to impact serum lipid levels.
- •Subjects with a history of binge eating behaviour, characterized by consuming a large amount of food in a short period of time with a sense of loss of control.
- •Subjects with any central nervous system disorder impeding exercise capability.
- •Subjects with major depressive disorder (MDD), anxiety disorder, or other mental illnesses at the time of screening.
- •Subjects with any musculoskeletal disorders preventing participation in exercise.
- •Subjects who have treated or plan to treat obesity with surgery or body weight loss devices during the trial.
- •Subjects with recent participation in any obesity program within the past 3 months.
- •Subjects intending to participate in another clinical study within the next month.
- •Subjects who have lost more than 5percent of their body weight in the preceding 3 months.
- •Subjects with any serious systemic diseases as determined by the investigator or other diseases believed by the investigator to potentially interfere with the results of this study or abnormal laboratory tests with clinical significance.
- •Subjects who, according to the opinion of investigators, are not suitable to participate in clinical trials including those who are physically or psychologically unable to comply with the protocol.
研究者
Dr Reginald Varadarajulu
Medstar Speciality Hospital