A Randomized, Double-blind Trial to Evaluate the Effect of a Functional Bioactive Supplement Associated With a Hypocaloric Equilibrated Diet to Treatment of Obese and Overweight Individuals
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Changes in body composition
研究概览
简要总结
The purpose this study is to evaluate the therapeutic effect of a functional bioactive supplement associated with a hypocaloric equilibrated diet to treat obese and overweight individuals. The functional bioactive supplement, containing antioxidant extracted from rosemary, oligosaccharides derived from lactulose and bioactive peptides, was developed to satiety control, improves of anti-inflammatory response and antioxidant defense mechanisms as well as to weight loss.
详细描述
A randomized, parallel, double-blind, controlled was performed to evaluate the therapeutic effect of a functional bioactive supplement associated with a hypocaloric equilibrated diet to treatment of obesity and overweight.
Women aged between 18 and 65 years with obesity and overweight diagnosis (IMC >25<35 kg/m2) were included in the study. The clinical trial will be performed in the Clinical Nutrition Department of La Paz University Hospital, in Madrid. All of the volunteers will receive a dietetic treatment with 1500 Kcal/day and physical activity recommendations during the study.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Women from 45 to 75 years old;
- •Overweight (IMC ≥25<30 Kg/m2) or obese (IMC ≥30<35 Kg/m2) volunteers
- •Signed informed consent.
排除标准
- •Subjects with drug consumption (lipid-lowering, oral hypoglycemic agents and / or hypertensive) in less than one month period;
- •Subjects with Diabetes Mellitus insulin dependent;
- •Individuals that stop smoking in the next 12 weeks (during the study);
- •Subjects with increased alcohol consumption (> 1 glass of vine);
- •Subjects that consume drugs, vitamins, minerals, prebiotics or/and probiotics that interfere with the body's response to the extracts in the 2 weeks before to baseline;
- •Subjects with drugs consumption special diet due to disease as celiac disease, chronic renal failure, etc;
- •Subjects with disorders associated with eating behaviour;
- •Subjects with drugs or supplements consumption to weight lost;
- •Subjects with physical problems complying with the recommendations of physical activity and diet indicated;
- •Subjects who refuse to perform the indicated dietary changes throughout the study;
- •Subjects with diseases that could be involucrate in weight lost (not controlled hypothyroidism, serious psychiatric illness, etc.);
- •Subjects with mental disease or low cognitive function;
- •Subjects with severe diseases (hepatic, kidney, cancer...);
- •Pregnant women or lactating;
- •Subjects with physical problems complying with the recommendations of physical activity.
- •Subjects with intensive physical activity;
结局指标
主要结局
Changes in body composition
时间窗: 12 weeks
Clinical response - changes in body composition: weight, waist circumference and Absorptiometry, Dual X-Ray.The primary outcome result measurement was the lost weight, changes in body composition
次要结局
- Metabolomic analyses(Week 0 and Week 12)
- Life style and health status: Life style and physical activity questionnaire(Week 0 and Week 12)
- Genetic analysis(Week 0 and Week 12)
- Endothelial function markers(Week 0 y Week 12)
- Satiety hormones(Week 0 y Week 12)
- Inflammatory markers(Week 0 and Week 12)
- Glucose Metabolism(Week 0 and Week 12)
- Lipid profile: Cholesterol(Week 0 and Week 12)
- Oxidative Stress Parameters(Week 0 and Week 12)
- Adverse effects(0 , 3, 6, 9 and 12 weeks)