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临床试验/NCT04392882
NCT04392882已完成不适用

Effects of Legumes Consumption on Weight Reduction

Yonsei University0 个研究点目标入组 400 人开始时间: 2011年3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
400
主要终点
Changes of urinary 8-epi-PGF2α

研究概览

简要总结

This is a 12-week, randomized nutritional intervention study to determine the effect of legumes consumption on body weight in obese subjects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female volunteers between the ages of 20 to 70 years
  • Body mass index (BMI) of 25 kg/m2 or higher (based on Asia-Pacific guideline)
  • Volunteers who have agreed to participate in the study and provided a written content by him/herself

排除标准

  • Those with type 2 diabetes, cardiovascular disease, psychiatric problems, thyroid disorders, liver or kidney disease
  • Those under the use of any medications (antihypertensive, lipid-lowering, antiplatelet, antidiabetic, etc.).

结局指标

主要结局

Changes of urinary 8-epi-PGF2α

时间窗: 12 weeks

Changes of urinary 8-epi-PGF2α in pg/mg creatinine was assessed before and after the intervention.

Changes of Insulin Resistance (IR)

时间窗: 12 weeks

Changes of fasting serum glucose in mmol/L was assessed before and after the intervention. Changes of fasting insulin in μIU/mL was assessed before and after the intervention. Fasting insulin and fasting glucose were combined to report IR using the following equation: homeostasis model assessment (HOMA)-IR=\[fasting insulin (μIU/mL)×fasting glucose (mmol/L)\] /22.5.

Changes of serum high C-reactive

时间窗: 12 weeks

Changes of serum high C-reactive in mg/L was assessed before and after the intervention.

Changes of adiponectin

时间窗: 12 weeks

Changes of adiponectin in ng/mL was assessed before and after the intervention.

Changes of BMI

时间窗: 12 weeks

Changes of weight in kilograms was assessed before and after the intervention. Changes of height in meters was assessed before and after the intervention. Weight and height were combined to report BMI in kg/m\^2.

Changes of lipid profiles

时间窗: 12 weeks

Triglyceride in mg/dL was assessed before and after the intervention. Total-cholesterol in mg/dL was assessed before and after the intervention. HDL-cholesterol in mg/dL was assessed before and after the intervention. LDL-cholesterol was indirectly estimated using the friedewald formula: LDL-cholesterol= total-cholesterol-\[HDL-cholesterol+(triglycerides/5)\].

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

Jong Ho Lee

Professor, Principal Investigator

Yonsei University

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