Efficacy and Safety of Obex®, a Nutritional Supplement, in Overweight or Obese Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- To evaluate the effect of OBEX on skinfolds
研究概览
简要总结
The aim of the study is to evaluate the effects of a dietary supplement (Obex®) on anthropometric and physiological variables in Spanish women between 35 and 60 years who are overweight or obese.
详细描述
The nutritional supplement consists of natural plant extracts such as Caralluma fimbriata, Phaseolus vulgaris, Acai Berry and other antiobesity agents: ornithine, carnitine fumarate, essential fatty acids and certain amino acids, vitamins and minerals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged between 35 and 60 years.
- •Body Mass Index (BMI) greater than 27 kg/m² and lower than 35 kg/m²
- •Ability to provide informed consent
排除标准
- •Presence of any endocrine, hepatic, renal or cardiovascular disease.
- •History of bariatric surgery
- •Pregnancy or lactation
- •Concomitant disease with reduced life expectancy
- •Severe psychiatric conditions
- •Drug dependence
研究组 & 干预措施
Obex, a nutritional supplement
Obex will be administered two sachets daily dissolved in a glass of water, 30 minutes before lunch and dinner during two months. Patients will be recommended to comply with a healthy lifestyle through diet and exercise.
干预措施: Obex (Dietary Supplement)
Placebo
Placebo will be administered two sachets daily dissolved in a glass of water, 30 minutes before lunch and dinner during two months. Patients will be recommended to comply with a healthy lifestyle through diet and exercise.
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the effect of OBEX on skinfolds
时间窗: Two months of treatment and three months after concluded the treatment
The primary outcome is to evaluate the effect of the treatment with OBEX on skinfold thickness of the biceps, triceps, subscapular and suprailiac as compared to placebo group at 2 months of treatment.
次要结局
- To evaluate the effect of OBEX on the waist and hip circumferences(Two months of treatment and three months after concluded the treatment)
- To evaluate the effect of Obex on the arm circumference.(Two months of treatment and three months after concluded the treatment)
- To evaluate the effect of Obex on the percentage of body fat(Two months of treatment and three months after concluded the treatment)
- To evaluate the effect of Obex on the muscular mass(Two months of treatments and three months after concluded the treatment)
- To evaluate the effect of Obex on arterial blood pressures.(Two months of treatment and three months after concluded the treatment)
- To evaluate the effect of Obex on fasting glucose and cholesterol levels(Two months of treatment and three months after concluded the treatment)