Inflammatory Indicators and Arterial Stiffness in Patients With Severe Obesity. Response to Supplementation of Alpha Linolenic Acid
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Reduction in arterial stiffness/intima thickness
研究概览
简要总结
Preliminary studies have shown that flaxseed powder, rich in the omega-3 alpha-linolenic acid,is beneficial for the general inflammation present in morbidly obese subjects by decreasing elevated serum markers.As omega-3 fatty acids display additional properties including possible amelioration of atherosclerosis,a 3-month supplementation protocol was devised.Arterial stiffness and intima thickness will be measured in severely obese subjects, in order to document possible reduction of these variables as well.
详细描述
Population:Morbidly obese non-smoking patients of the Department of Gastroenterology, candidates for possible bariatric treatment Criteria for inclusion: Males and females, 18- 65 years old, body mass index/BMI > 40 kg/m2 (or > 35 kg/m2 with comorbidities), non-hospitalized and receiving general oral diet, with elevated C-reactive protein/ CRP (> 5mg/L), and signing informed consent; Criteria for exclusion: SIRS, shock, coma or organ failure, fever or infectious foci, cancer with or without chemo/radiotherapy, inflammatory illnesses (rhematic, gastrointestinal or other), transplantation or immunologic diseases, trauma, surgery or hospitalization in the last 30 days, use of steroidal or non-steroidal anti-inflammatory or immune-modulating agents or antibiotics, and refusal to participate in the study; Dietetic routine: Daily flaxseed powder (Farinha de linhaca dourada) 60 g/day (232 kcal , containing 10 g of alpha-linolenic acid/ALA) or placebo (commercial manioc flour 60 g/day, 120 kcal)) during 12 weeks. An additional 60 subjects (30 patients, 30 controls) will ve managed with 30 ml/day flaxseed oil (10 g of alpha-linolenic acid/ALA) or 30 ml/day placebo (safflower oil).
Methods: Clinical questionnaire,nutritional assessment(Weight, height, BMI) Biochemical tests: Hemoglobin (HB) , white blood cell count (WBC), total cholesterol (CHOL) and fractions (HDL, LDL, VLDL), triglycerides (TRIG), blood glucose (GLU), serum albumin (ALB),insulin (INS), leptin (LEP),C-reactive protein (CRP), serum amyloid A (SAA), complement fractions C3 and C4, coagulation profile Atherosclerosis markers: Arterial stiffness (aorta) and intima thickness (common carotid artery)
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, Care Provider)
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
- •Males and females
- •18- 65 years old
- •Body mass index/BMI > 40 kg/m2 (or > 35 kg/m2 with comorbidities)
- •Non-hospitalized and receiving general oral diet
- •With elevated C-reactive protein/ CRP (> 5mg/L); and
- •Signing informed consent
排除标准
- •SIRS, shock, coma or organ failure,
- •Fever or infectious foci
- •Cancer with or without chemo/radiotherapy
- •Inflammatory illnesses (rhematic, gastrointestinal or other), transplantation or immunologic diseases
- •Trauma, surgery or hospitalization in the last 30 days
- •Use of steroidal or non-steroidal anti-inflammatory or immune-modulating agents or antibiotics; and
- •Refusal to participate in the study
结局指标
主要结局
Reduction in arterial stiffness/intima thickness
时间窗: 12 weeks
次要结局
- Improvement in inflammatory markers and serum lipids(12 weeks)
研究者
Joel Faintuch
Associate Professor, Department of Gastroenterology, Sao Paulo University Medical School
University of Sao Paulo