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临床试验/NCT05290519
NCT05290519Unknown不适用

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

National Taiwan Normal University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
change from 12 week blood leptin level at 16 week

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 64 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Group A

Experimental

plant protein for 4 weeks than animal protein for 4 weeks

干预措施: plant and animal protein (Other)

Group B

Experimental

animal protein for 4 weeks than plant protein for 4 weeks

干预措施: plant and animal protein (Other)

结局指标

主要结局

change from 12 week blood leptin level at 16 week

时间窗: 12, 16 week

blood leptin level will be measured before and after intervention

change from 12 week blood adiponectin level at 16 week

时间窗: 12, 16 week

blood leptin level will be measured before and after intervention

change from 4week blood advanced glycation end products level at 8 week

时间窗: 4, 8 week

blood AGEs level will be measured before and after intervention

change from 12 week blood advanced glycation end products level at 16 week

时间窗: 12, 16 week

blood AGEs level will be measured before and after intervention

change from 4 week blood leptin level at 8 week

时间窗: 4, 8 week

blood leptin level will be measured before and after intervention

change from 4 week blood adiponectin level at 8 week

时间窗: 4, 8 week

blood leptin level will be measured before and after intervention

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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