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Comparison of Plant-based or Animal-based Protein on Anthropocentric and Metabolic Parameters in Obese Subjects

2022年3月13日 更新者:National Taiwan Normal University
The investigators will try to evaluate the effects of substitution of dietary animal protein by black soybean milk (400 mL x 2) per day on anthropocentric and metabolic parameters in obese subjects.

研究概览

详细说明

According to the survey by the Ministry of Health and Welfare, the proportion of obese male adolescents in Taiwan has been increasing year by year. Obesity is associated with chronic low-grade inflammation. Obese people prefer to intake foods containing higher levels of advanced glycation end products (AGEs). High intake of dietary AGEs (dAGEs) results in abdominal obesity, and shows positive correlation with body mass index (BMI) and waist circumference. When a large amount of AGEs accumulates in the body, inflammation usually occurs. Therefore, reducing dAGEs intake prevents the incidence of obesity, chronic diseases and aging. Black beans are high in protein. The black bean coats contain high level of anthocyanins. Previous studies demonstrated the biological functions of anthocyanins on blood lipid regulation, inflammation, and also inhibition of AGEs formation. Compared with meat (beef, pork, lamb, chicken, and seafood), the plant protein source, soy milk, under the same protein content showed significantly lower dAGE. In this study, the investigators will try to eveluate the effects of substitution of dietary animal protein by black soybean milk (400 mL x 2) per day on anthropocentric and metabolic parameters in obese subjects. This will be a randomized crossover interventional trial for 16 weeks: 0 to 4 weeks will be run-in period, 4 to 8 weeks and 12 to 16 weeks will be the soy milk or meat intervention period, and the between of two interventions (8 to 12 weeks) will be washout period. The body composition, blood pressure and AGE level will be measured. The blood, urine and feces sample will be collected for biochemical analysis and gut microbiome. The investigators expect the results could support the promotion of plant protein as part of dietary protein source to improve abnormal anthropometric and metabolic parameters in obese subjects.

研究类型

介入性

注册 (预期的)

30

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。

学习联系方式

学习地点

      • Taipei、台湾、106
        • 招聘中
        • National Taiwan Normal University
        • 接触:

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 64年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 20 to 64 year male or female
  • 27 <= BMI < 35 or waist circumference male >= 90 cm/female >= 80 cm
  • fasting blood glucose: 100-125 mg/dL

Exclusion Criteria:

  • Hypertension, cardiovascular disease, endocrine disease, acute and chronic liver and kidney disease, mental disease, binge or anorexia, or long-term drug use
  • Consume probiotics, prebiotics, antibiotics or weight loss drugs regularly for the past month
  • Try to lose weight and do resistance exercise regularly for the past month
  • Allergic to soy products

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:预防
  • 分配:随机化
  • 介入模型:交叉作业
  • 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:Group A
plant protein for 4 weeks than animal protein for 4 weeks
plant protein: 2 bottle of black soy milk (400 mL/bottle) for 4 weeks animal protein: pork dished for 4 weeks
实验性的:Group B
animal protein for 4 weeks than plant protein for 4 weeks
plant protein: 2 bottle of black soy milk (400 mL/bottle) for 4 weeks animal protein: pork dished for 4 weeks

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
change from 4week blood advanced glycation end products level at 8 week
大体时间:4, 8 week
blood AGEs level will be measured before and after intervention
4, 8 week
change from 12 week blood advanced glycation end products level at 16 week
大体时间:12, 16 week
blood AGEs level will be measured before and after intervention
12, 16 week
change from 4 week blood leptin level at 8 week
大体时间:4, 8 week
blood leptin level will be measured before and after intervention
4, 8 week
change from 12 week blood leptin level at 16 week
大体时间:12, 16 week
blood leptin level will be measured before and after intervention
12, 16 week
change from 4 week blood adiponectin level at 8 week
大体时间:4, 8 week
blood leptin level will be measured before and after intervention
4, 8 week
change from 12 week blood adiponectin level at 16 week
大体时间:12, 16 week
blood leptin level will be measured before and after intervention
12, 16 week

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:Wan-Ju Yeh、National Taiwan Normal University

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)

2022年3月1日

初级完成 (预期的)

2022年12月31日

研究完成 (预期的)

2022年12月31日

研究注册日期

首次提交

2022年3月1日

首先提交符合 QC 标准的

2022年3月13日

首次发布 (实际的)

2022年3月22日

研究记录更新

最后更新发布 (实际的)

2022年3月22日

上次提交的符合 QC 标准的更新

2022年3月13日

最后验证

2022年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

IPD will be published in journals

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

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

plant and animal protein的临床试验

3
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