Efficacy of STABLOR® on Visceral Fat Mass Reduction in Patients With Metabolic Syndrome
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LNC THERAPEUTICS
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| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 10, 2018 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 4, 2018 | ||
| 预计研究开始日期 ICMJE | September 11, 2018 | ||
| 预计主要完成日期 | December 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Absolute change of visceral fat mass (in cubic millimeter) assessed by Magnetic Resonance Imaging[ Time Frame: between week 0, week 9, week 12 ] |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Efficacy of STABLOR® on Visceral Fat Mass Reduction in Patients With Metabolic Syndrome | ||
| 正式标题 ICMJE | A 3-month Randomized Double Blind Placebo-controlled Multicenter Study to Assess the Efficacy of STABLOR® on Visceral Fat Mass Reduction in Patients With Metabolic Syndrome | ||
| 简要概况 | The primary objective of the study is to assess the efficacy of STABLOR® consumption on visceral fat mass compared to placebo, in persons with metabolic syndrome during 12 weeks of consumption. |
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| 详细说明 | It is expected that the food product STABLOR will reduce visceral fat mass in subjects with metabolic syndrome and therefore will improve cardiometabolic risk factors. The aim of the current study is to assess the impact of a 12-week intake of STABLOR, compared to a placebo, on visceral fat in patients with metabolic syndrome. The primary objective of the study is to assess the efficacy of 12-week STABLOR® consumption on visceral fat mass compared to placebo, in persons with metabolic syndrome. The Secondary outcomes include Anthropometric measurements and body composition, metabolic syndrome status, STABLOR® metabolism, Cardiovascular biomarkers, Systemic inflammation, Quality of life and Behavior. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
240 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | December 2019 | ||
| 预计主要完成日期 | December 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Female or male - Age between 18 and 65 years (limits included), - BMI between 27 and 40 kg/m² (limits included), - With metabolic syndrome: Waist circumference > 94 cm for male (>90 cm for male of South-East Asian, Chinese and Japanese ethnic groups) and > 80 cm for female and at least two of the following criteria : - Triglycerides levels ≥ 1.5 g/L (1.71 mmol/L) or stable under treatment for at least 6 months, - HDL cholesterol levels <0.40 g/L (1.03 mmol/L) for male and <0.5 g/l (1.29 mmol/L) for female or stable under treatment for at least 6 months, - Fasting plasma glucose ≥1 g/L (5.6 mmol/L) and non-diabetic, - Blood pressure ≥130 mmHg (systolic) and/or 85 mmHg (diastolic) or stable under antihypertensive treatment for at least 6 months, - Good general and mental health with in the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination, - Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form, Exclusion Criteria: - Suffering from a metabolic disorder such as diabetes uncontrolled thyroidal trouble or other metabolic disorder, - Suffering from a cardiac insufficiency, inflammatory disease, severe hepatic of renal insufficiency, or gastrointestinal disorders (Crohn's disease or Ulcerative Colitis) or others diseases found to be inconsistent with the conduct of the study by the investigator (e.g. celiac disease), - Having suffered of stroke or ictus within the last 6 months, - Suffering of depression, - Had a major surgical procedure within the last 6 months, - Had a bariatric surgery, - With a known or suspected food allergy or intolerance to lactose or soja, or hypersensitivity to any of the study products' ingredient, - Who does not like the investigational product flavors "vanilla-toffee", "chocolate" and "coffee", - Having a biological selection profile considered as abnormal by the investigator (BUN, Creatinine, calcium, Liver enzymes (GGT, AST, ALT), Blood Cell Count, , HIV, HCV, lipids (TG, HDL, LDL, total cholesterol),glycaemia, B HCG), - Pregnant (positive pregnancy test at selection visit) or lactating women or intending to become pregnant within 6 months ahead, - Women of child bearing potential without efficient contraception, - Under nutritional supplement or drugs acting on weight or satiety according to the investigator or stopped less than 6 months before the study, - With a current or planned in the next 6 months specific diet (hypocaloric, vegan, vegetarian…) or stopped less than 6 months before the study, - Treated with drugs acting on visceral fat mass &inflammation : corticosteroids, neuroleptics, alpha et beta blockers, anti-HIV tritherapy, anti-TNF alpha, antidepressant or anticoagulating agents, - Treated with antibiotics in the 3 months prior to selection, - With significant change in food habits or in physical activity in the 6 months before the V0 visit, - With significant changes in lipid abnormality of antihypertensive treatment within 3 months prior to selection, - With a personal history of bulimia or significant eating disorders according to the investigator, - Consuming more than 3 standard drinks of alcoholic beverage daily for men or 2 daily for women or not agreeing to keep his alcohol consumption habits unchanged throughout the study, - Consuming tobacco, - Consuming drugs, - Patients who suffer from claustrophobia, - Patients who have contraindications to perform an MRI such as pacemakers, intracranial clips incompatible with MRI, heart valves, hearing aid,... and other types of implants incompatible with MRI, - Taking part in another clinical trial or being in the exclusion period of a previous clinical trial, - Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision, - Presenting a psychological or linguistic incapability to sign the informed consent, - Impossible to contact in case of emergency. | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：65 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | France | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | LNC THERAPEUTICS | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | September 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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