NCT01755104已完成不适用
A Randomized Double-blind Placebo Controlled Trial on the Effect of Stablor™ on the Abdominal Visceral Fat Mass Loss in Patients With a Metabolic Syndrome
Laboratoires Nutrition et Cardiometabolisme2 个研究点 分布在 2 个国家目标入组 118 人开始时间: 2013年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Change in visceral fat area assessed by computerized tomodensitometry
研究概览
简要总结
The purpose of the study is to evaluate the impact of the intake of a dietary supplement STABLOR™ on the change of the abdominal visceral fat mass in patients with a metabolic syndrome.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With a Body Mass Index (BMI) more than or equal to 25 kg/m² and less than 40 kg/m²,
- •With a metabolic syndrome characterized by a a waist circumference of more than 94 cm for the males (90 cm for South-Asians, Chinese and Japanese) and more than 80 cm for the females, and at least 2 of the following criteria :
- •Arterial Blood pressure > or = 130 mmHg (systolic) and/or more than or equal to 85 mmHg (diastolic) or stabilized with treatment for at least 6 months,
- •Fasting glycemia > or = 1 g/L or 5.6 mmol/L or stabilized with treatment for at least 6 months and non-diabetic < 1.26 g/L,
- •Triglycerides > or = 1.5 g/L or 1.71 mmol/L or stabilized with treatment for at least 6 months,
- •HDL Cholesterol <0.40 g/L or 1.03 mmol/L (males) and <0,5 g/l or 1.29 mmol/L (females) or stabilized with treatment for at least 6 months.
排除标准
- •Pregnant (positive pregnancy test at the selection visit or breast-feeding woman,
- •Woman of childbearing potential without an efficient contraception method,
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in the clinical trial
结局指标
主要结局
Change in visceral fat area assessed by computerized tomodensitometry
时间窗: From baseline to Week 12
次要结局
- Quality of life, psychological and behavioral changes(From baseline to end of study)
- Changes in selected cardiometabolic risk factors : anthropometric and physical measurements, biomarkers(from baseline to end of study)
研究者
研究点 (2)
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