NCT03541005已完成3 期
Efficacy and Safety of the Obex® Nutritional Supplement in Overweight and Obese Subjects: Phase III.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Change From Baseline in Waist Circumference at Week 24.
研究概览
简要总结
- Obesity is an important and growing worldwide
- Obesity is highly related to the development of metabolic syndrome, diabetes, cardiovascular diseases and cancer
- Diverse adverse events have been reported with the use of antiobesity drugs.
- Several articles describe the beneficial effect of several specific components of the Obex® supplement on weight loss, in the reduction of waist circumference, suppression of appetite, decrease fasting glucose levels, improvement of insulin sensitivity and β cells function.
- Therefore, the administration of Obex in overweight and obese patients could be an excellent strategy to induce weight loss and ameliorate the metabolic disturbances related to obesity and overweight.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who fulfill the diagnosis criteria of overweight or obesity (BMI ≥ 25.0 and less than 40).
- •Age between 20 and 65 years old.
- •Values of fasting glucose < 7.0 mmol / L and at two hours < 11.1 mmol / L during Glucose Tolerance Test (OGTT).
- •Written informed consent of participation in the study.
排除标准
- •Thyroid dysfunction (hypo or hyperthyroidism).
- •Type 1 or type 2 diabetes.
- •Prediabetes treated with oral agents.
- •Alterations of lipids treated with drugs.
- •Medicine consumption of or dietary supplements that influence the reduction of body weight.
- •Consumption of steroids or prolonged use of them (last 3 months).
- •Treatment with immunosuppressive drugs.
- •Chronic diseases (of the hepatic, renal and cardiovascular systems, pancreatitis or some type of malignancy condition) or acute at the time of inclusion.
- •Insulin resistance due to diseases such as acromegaly, endogenous hypercortisolism, polycystic ovarian syndrome or hyperprolactinemia.
- •History of symptomatic hypoglycaemia.
- •History of chronic debilitating diseases, anemia and collagen diseases.
- •History or existence psychological illness with eating disorders or toxicity.
- •History of alcoholism or drug dependence.
- •Inability to comply with the instructions of the investigation.
- •Severe infections at the time of inclusion.
- •Women of childbearing age who use hormonal contraceptives (oral or injectable).
- •Pregnant or breastfeeding.
- •Known sensitivity to any of the components of the formulation
- •Gynoid fat distribution.
结局指标
主要结局
Change From Baseline in Waist Circumference at Week 24.
时间窗: Six months
Change in waist circumference from baseline after six months of treatment (i.e., waist circumference at six month minus waist circumference at baseline 0). Waist measured in centimeters (cm).
Change From Baseline in Body Weight.
时间窗: Six months
Change in body weight from baseline (0) after six months of treatment (i.e., weight at six month minus weight at baseline 0). Body weight measured in kilograms (k).
To evaluate the effect of Obex® on fasting glucose levels.
时间窗: Six months
The primary outcome is to evaluate the effect of the treatment with Obex® on fasting glucose levels by blood analysis.
次要结局
- To evaluate the effect of Obex® on insulin resistance.(Six months)
- To evaluate the effect of Obex® on β-cell function.(Six months)
- To evaluate the effect of Obex® on creatinine and uric acid concentrations.(Six months)
- To evaluate the effect of Obex® on haemoglobin levels.(Six months)
- To evaluate the effect of Obex® on Body Mass Index (BMI).(Six months)
- To evaluate the effect of Obex® on the waist and hip ratio.(Six months)
- To evaluate the effect of Obex® on the waist and height ratio.(Six months)
- To evaluate the effect of Obex® on arterial blood pressures (BP).(Six months)
- To evaluate the effect of Obex® on insulin sensitivity.(Six months)
- To evaluate the effect of Obex® on cholesterol.(Six months)
- To evaluate the effect of Obex® on hepatic enzymes.(Six months)
- To evaluate the effect of Obex® on fasting insulin levels.(Six months)
- To evaluate the effect of Obex® on Conicity Index (CI)(Six months)
研究者
研究点 (2)
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