Evaluation of the Efficacy of Plant-based Approaches to Stop Obesity Diet in Comparison With a Control Group on Body Weight in Mexican Adults With Overweight and Obesity: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in body weight
研究概览
简要总结
The accumulation of excess of body weight is one of the most important problems worldwide, thus effective and accessible treatments are required. Some authors highlighted that treatment is focused solely on lifestyle (diet, physical activity, behavioral therapy) has a limited effect on body weight because it does not consider the biological mechanisms linked to weight loss in patients with obesity. On the other hand, drugs and bariatric surgery consider these biological approaches; however, its costs, safety and effectiveness limits its use on a large scale. Research studies support the existence of compounds in plants (such as epigallocatechin gallate, caffeine, cinnamaldehyde, fiber), and water with biological properties that would contribute to the treatment of overweight and obesity. However, at the moment, these compounds have only been evaluated individually and their effects have been significant but limited clinically, therefore, more research studies are needed to evaluate whether several of these compounds contained in common plants synergistically have a clinical impact on the management of overweight and obesity. The present work integrates diverse plant-based approaches to stop obesity and it is compared with a control group and a waiting list group. The main aim is to evaluate the efficacy of the Plant-based Approaches to Stop Obesity diet (PASO diet) compared with a control group on body weight at 3 months in Mexican adults with overweight and obesity. This is a pilot study designed as a randomized controlled trial. The study will be conducted with a (n=36). The primary outcome is the change in body weight from baseline to 3 months. Secondary outcomes will be the changes from baseline to 3 months in body mass index, waist circumference, systolic and diastolic blood pressure, symptoms of depression, quality of life scales and biochemical parameters (fasting glucose, total cholesterol, LDL cholesterol, HDL-cholesterol, triglycerides and gamma glutamyl transferase). Additionally two 24-hour dietary recall will be measured at baseline and 3 months to evaluate adherence to the intervention.
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
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mexican adults (> 20 years and <55)
- •Residents of the city of Hermosillo, Sonora
- •Obesity (BMI> 25 and <45)
- •Availability of time to participate in the study.
- •Economic capacity to acquire the assigned diet
- •Grant informed consent
- •Keep a dietary record for one week prior to the intervention
排除标准
- •Medical conditions that constitute a contraindication for the intervention, such as de-controlled diabetes, dyslipidemia with pharmacological treatment, blood pressure ≥160 / 100 mmHg, heart failure, renal failure, etc.
- •Previous bariatric surgery
- •Participate in another intervention or treatment for the management of obesity
- •Use of drugs or substances with an effect on weight, for example, metformin, orlistat or corticoids
- •Weight loss> 5% of total body weight in the last 4 months
- •Pregnancy or lactation
- •Another member of the family or acquaintance who has agreed to participate in the study
- •Consumption of more than 10 alcoholic drinks per week
- •Use of addictive substances as drugs of abuse
- •Psychiatric condition that prevents adherence to treatment, such as severe depression, bipolarity and schizophrenia Illiteracy
- •Gastrointestinal problems or any condition where coffee, tea or cinnamon are not well tolerated or contraindicated
- •People who drink more than 4 cups of coffee (tea) per day or its equivalent in caffeinated beverages.
结局指标
主要结局
Change in body weight
时间窗: baseline to 3 months
次要结局
- Change in HDL-cholesterol(baseline to 3 months)
- Change in triglycerides(baseline to 3 months)
- Change in waist circumference(baseline to 3 months)
- Change in the Beck Depression Inventory score(baseline to 3 months)
- Change in fasting glucose(baseline to 3 months)
- Change in total cholesterol(baseline to 3 months)
- Change in gamma glutamyl transferase(baseline to 3 months)
- Change in body fat percentage(baseline to 3 months)
- Change in systolic and diastolic blood pressure(baseline to 3 months)
- Change in LDL-cholesterol(baseline to 3 months)
- Change in the Short Form-36 Health Survey score(baseline to 3 months)
研究者
Rolando Giovanni Díaz Zavala
Principal Investigator
Universidad de Sonora