Effect of the Administration of Conjugated Linoleic Acid / Leucine Plus Metformin on Visceral Fat in Patients With Metabolic Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 主要终点
- Change from Baseline in visceral fat area messure in centimers ^2 at 8 weeks
研究概览
简要总结
In Mexico, obesity is a major public health problem. In recent years he has presented a considerable increase in the population. As a result, it has triggered a proportional increase in the incidence of cardiovascular disease and the development of Metabolic Syndrome (METS). Abdominal obesity is one of the main components of METS which is generally associated with insulin resistance / hyperinsulinemia. This is influenced both by the subcutaneous adipose tissue as visceral adipose tissue. There is evidence that the visceral fat has an important bearing on many factors of METS, like: glucose intolerance, hypertension, dyslipidemia, and insulin resistance.
For management it requires a multidisciplinary approach, including changes in lifestyle, psychological and nutritional intervention as well as pharmacological and non-pharmacological support.
Among non-pharmacological therapies, there is recently the use of Conjugated Linoleic Acid (ACL) and leucine where in its assigned properties include weight reduction, anti-atherogenic , hypocholesterolemic and immunostimulant effect and anticarcinogenic properties. Regarding weight reduction dominates the mechanism of action anti-lipolytic effect. But, studies are needed to link this consumption with the increase or decrease on visceral fat in individuals with METS.
详细描述
The main objective is to compare the effect of the administration of ACL/Leucine vs. Metformin on visceral fat area in patients with METS. We will conduct a double-blind trial, randomized, on 4 groups, each group with 26 male and female patients of 35-65 years of age with METS diagnosed by IDF criteria. Randomization will determine who will receive the intervention during 8 week trial, each group will be like:
Group (A) intervention with ACL/Leucine plus Metformin: 26 individuals will receive ACL/Leucine in a dosis of 2,475mg per 24 hrs (1,650mg or 2 capsules with the first meal and 825 mg or 1 capsule with the second meal) plus Metformin in a dose of 500 mg per day (with the first bite of the second meal) during 8 weeks.
Group (B) Metformin plus Placebo of ACL/Leucine: 26 individuals will receive Metformin in a dose of 500 mg per day (with the first bite of the second meal) plus homologue placebo of ACL/Leucine (linseed oil capsules) in a dosis of 3600 mg each 24 hrs (2 capsules of 2400 mg with the first meal and 1200 mg or 1 capsule with the second meal) during 8 weeks.
Group (C) ACL/Leucine plus Metformin's Placebo: 26 individuals will receive ACL/Leucine in a dose of 2,475mg per 24 hrs (1,650mg or 2 capsules with the first meal and 825 mg or 1 capsule with the second meal) plus homologate placebo of metformin (calcined magnesia) in a dose of 500 mg per day (with the first bite of the second meal) during 8 weeks.
Group (D) Placebo of ACL/Leucine plus Placebo of Metformin: homologate placebo of ACL/Leucine (linseed oil capsules) in a dose of 3600 mg each 24 hrs (2 capsules of 2400 mg with the first meal and 1200 mg or 1 capsule with the second meal) plus homologated placebo of metformin (calcined magnesia capsules) in a dosis of 500 mg per day (with the first bite of the second meal) during 8 weeks.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of metabolic syndrome by IDF criteria:
- •Central obesity (defi ned as waist circumference* with ethnicity specifi c values)≥80 cm in females and ≥90 cm in males
- •plus any two of the following four factors:
- •Raised triglycerides ≥ 150 mg/dL (1.7 mmol/L) or specific treatment for this lipid abnormality Reduced HDL colesterol
- •< 40 mg/dL (1.03 mmol/L) in males < 50 mg/dL (1.29 mmol/L) in females or specifi c treatment for this lipid abnormality
- •Raised blood pressure systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg or treatment of previously diagnosed hypertension
- •Raised fasting plasma glucose (FPG) ≥ 100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes
- •Stable body weight in the last 3 months
- •Written informed consent
排除标准
- •With previous abdominal surgery
- •Pathologies that course with abdominal wall edema fluid retention
- •Paniculitis of reumatic origin or any other ethiology
- •Reumatic pathologies
- •Metalic prothesis
- •Previous known allergy to any of the ingredients that make up the active treatments assigned
- •Known problem of fat absortion, esteatorrea, lipase deficiency, malabsortion of intestinal problems, CUCI
研究组 & 干预措施
cojugated ALC/Leucine+Metformin
Intervention with conjugated linoleic acid/Leucine + 500mg in individuals with METS
干预措施: Conjugated linoleic acid/Leucine (Dietary Supplement)
cojugated ALC/Leucine+Metformin
Intervention with conjugated linoleic acid/Leucine + 500mg in individuals with METS
干预措施: Metformin (Drug)
Metformin+placebo conjugatedALC/leucine
active comparator with Metformin 500mg + Placebo of ACL/Leucine in individuals with METS
干预措施: Metformin (Drug)
Metformin+placebo conjugatedALC/leucine
active comparator with Metformin 500mg + Placebo of ACL/Leucine in individuals with METS
干预措施: Placebo of ACL/Leucine (Dietary Supplement)
Placebo of Metformin
Active comparator with ACL/Leucine + Placebo of Metformin in individuals with METS
干预措施: Conjugated linoleic acid/Leucine (Dietary Supplement)
Placebo of Metformin
Active comparator with ACL/Leucine + Placebo of Metformin in individuals with METS
干预措施: Placebo of Metformin (Other)
ACL/Leu placebo
Placebo comparator with ACL/Leu placebo + Metformin placebo in individuals with METS
干预措施: Placebo of ACL/Leucine (Dietary Supplement)
ACL/Leu placebo
Placebo comparator with ACL/Leu placebo + Metformin placebo in individuals with METS
干预措施: Placebo of Metformin (Other)
结局指标
主要结局
Change from Baseline in visceral fat area messure in centimers ^2 at 8 weeks
时间窗: baseline and 8 weeks
Before and after intervention using a visceral fat monitor Omron's dual impedance analysis method scan HDS-2000
次要结局
- 2. Change from Baseline epicardial fat area messure in milimeters ^2 at 8 weeks(baseline and 8 weeks)
- 1. Change from Baseline in weight expressed in kg at 8 weeks(baseline and 8 weeks)
- Change from baseline in Body Mass Index, expressed in kg/m^2 at 8 weeks(baseline and 8 weeks)
- Change from baseline in Total Tody Fat, expressed in percentage at 8 weeks(baseline and 8 weeks)
研究者
Fernando Grover Paez
Fernando Grover-Paez, PhD
Centro Universitario de Ciencias de la Salud, Mexico