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Evaluation of the Plant-based Approaches to Stop Obesity Diet for the Treatment of Overweight and Obesity (PASO diet)

2020年4月14日 更新者:Rolando Giovanni Díaz Zavala、Universidad de Sonora

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

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.

研究概览

研究类型

介入性

注册 (预期的)

36

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Sonora
      • Hermosillo、Sonora、墨西哥、83000
        • 招聘中
        • Centro de Promoción de Salud Nutricional (CPSN)
        • 接触:
        • 首席研究员:
          • Rolando Giovanni Díaz Zavala, Ph.D.

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 55年 (成人)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:PASO diet group
This group include a low-fat, low calorie diet (1200-1800 kcal), in addition of a behavioral change protocol. They will also be instructed to consume green tea (2 cups/day for 3 days/week), black tea (2 cups/day for 2 days/week), coffee (2 cups/day for 2 days/week), cinnamon (1 tsp/day for at least 3 days/week), psyllium fiber (3 tsp/day/week) and water (1.5 L/day/week).
有源比较器:Low-fat diet group
This group include a low-fat, low calorie diet (1200-1800 kcal), in addition of a behavioral change protocol.
其他:Waiting list group
This group will only receive written information with recommendations on healthy eating. When the study finished, this group will receive a behavioral change protocol with a low-fat, low calorie diet.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
体重变化
大体时间:基线至 3 个月
基线至 3 个月

次要结果测量

结果测量
措施说明
大体时间
空腹血糖的变化
大体时间:基线至 3 个月
基线至 3 个月
总胆固醇的变化
大体时间:基线至 3 个月
基线至 3 个月
低密度脂蛋白胆固醇的变化
大体时间:基线至 3 个月
基线至 3 个月
HDL-胆固醇的变化
大体时间:基线至 3 个月
基线至 3 个月
甘油三酯的变化
大体时间:基线至 3 个月
基线至 3 个月
Γ 谷氨酰转移酶的变化
大体时间:基线至 3 个月
基线至 3 个月
Change in waist circumference
大体时间:baseline to 3 months
baseline to 3 months
Change in body fat percentage
大体时间:baseline to 3 months
baseline to 3 months
Change in the Beck Depression Inventory score
大体时间:baseline to 3 months
The Beck Depression Inventory (BDI) is a 21-item questionnaire that assesses mood over the previous week. Total scores range from 0 to 63, with higher values indicating greater symptoms of depression. Scores of 0-9 reflect minimal (subclinical) symptoms, values of 10-18, 19-29, and ≥30 indicate mild, moderate, and severe symptoms of depression, respectively.
baseline to 3 months
Change in the Short Form-36 Health Survey score
大体时间:baseline to 3 months
The SF-36 Health Survey evaluates aspects of the quality of life in adult populations (over 16 years of age). The result of its application is the generation of eight concepts or scales of health, result of the average of the sum of the questions contained in the questionnaire for each concept. These concepts are: physical function, physical role, corporal pain, general health, vitality, social function, emotional role and mental health. The SF-36 is a self-applied instrument and contains 36 questions. For each scale, the answers to each question are coded and recoded (10 questions), and the results are interpreted on a scale of 0 to 100, lower results indicate poorer health and greater result better health).
baseline to 3 months
Change in systolic and diastolic blood pressure
大体时间:baseline to 3 months
baseline to 3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Rolando G Díaz Zavala, Ph.D.、Universidad de Sonora

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年10月10日

初级完成 (预期的)

2021年7月31日

研究完成 (预期的)

2021年7月31日

研究注册日期

首次提交

2018年7月23日

首先提交符合 QC 标准的

2018年7月23日

首次发布 (实际的)

2018年7月31日

研究记录更新

最后更新发布 (实际的)

2020年4月15日

上次提交的符合 QC 标准的更新

2020年4月14日

最后验证

2020年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • PASOdiet-OBMEX-2018

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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PASO diet group的临床试验

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