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临床试验/NCT05455164
NCT05455164已完成不适用

The Effect of Eucaloric High-Protein Fiber Diet on Anthropometric and Metabolic Profile of Healthy Adults: A Repeated Single-Arm Clinical Trial

Universitas Katolik Widya Mandala Surabaya2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Fasting Plasma Glucose

研究概览

简要总结

The aims of this study is to investigate the effect of eucaloric high protein and fiber diet on healthy subjects.

详细描述

Several studies have shown that high protein diet can reduce body fat, increase muscle mass, and improve some metabolic parameters of subjects. Also, several studies have shown that high intake of fiber could reduce body weight and improve cardiometabolic parameters. Therefore, combining high-protein diet and high-fiber diet should have a positive synergistic effect on several of anthropometric and metabolic parameters. The aims of this study is to investigate the effect of eucaloric high protein and fiber diet on healthy subjects. Thirteen healthy subjects, age 29,85 ± 4,06 years old, with body mass index (BMI) 29,55 ± 4,12 kg/m2 were prescribed eucaloric high protein diet for two weeks, followed by washing period for two week. Then, they were prescribed with eucaloric high protein and high fiber diet for two more weeks. Twenty grams of dietary fiber were in the form of isomaltooligosaccharides (IMO) based creamer formulae. Their body composition, waist circumference, fasting blood glucose, blood uric acid and total cholesterol concentration were measured after every dietary intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • (BMI) of >= 25.0
  • Healthy subjects

排除标准

  • pregnant,
  • under any medication
  • having any kind of diseases and acute infection

结局指标

主要结局

Fasting Plasma Glucose

时间窗: 2 weeks after meal

Fasting Plasma Glucose mmol/dl

body composition analysis (Arm-, Trunk-, Leg Fat composition)

时间窗: 2 weeks after meal

in Kg or %

Plasma Uric Acid

时间窗: 2 weeks after meal

Plasma Uric Acid mg/dl

Total Cholesterol

时间窗: 2 weeks after meal

Total Cholesterol Mg/dl

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hendy Wijaya

Head of Clinical Pharmacology research laboratories

Universitas Katolik Widya Mandala Surabaya

研究点 (2)

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