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临床试验/NCT03251014
NCT03251014已完成不适用

The Thrombotic Effects of Yellowstripe Scad (YSS) Compared to Salmon Among Healthy Overweight Subjects: A Randomized Cross Over Trial

Universiti Putra Malaysia0 个研究点目标入组 50 人开始时间: 2016年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
主要终点
Changes in hemostatic status assessed by immunoassay method

研究概览

简要总结

The study aimed to determine the thrombotic effects of YSS compared with salmon among healthy overweight subjects. It hypothesized that YSS may result significant, favorable thrombotic effects and the effects may be similar with salmon.

详细描述

The project was a randomized, two-period, crossover trial with 8-week treatment periods and 8-week washout period. A total of 50 healthy overweight adults were recruited among staff and students in UPM. All the subjects were randomized into two groups. Each group was served with either cooked YSS (~265 g/ day) or salmon (~246 g/day) thrice per week. Blood and urine samples were collected for laboratory assessment.

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
21 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Malaysian
  • Overweight participants (BMI 23-27.4 kg/m2)

排除标准

  • Regular use of fish oil supplements during the last one month
  • Regular consumption of fish twice or more per week
  • Vegetarian who excluded all meat, fish, and poultry from their diet
  • Diagnosed with cardiovascular disease, haemostasis disorder, inflammatory disease, diabetes mellitus, hypertension, or other significant medical history that may prohibits the participation
  • Receiving warfarin or aspirin treatment, or medication to lower serum lipids, blood pressure, and inflammation
  • Women who are menopause, pregnant or lactating

研究组 & 干预措施

YSS/salmon group

Experimental

YSS followed by salmon

干预措施: Salmon (Other)

YSS/salmon group

Experimental

YSS followed by salmon

干预措施: YSS (Other)

Salmon/YSS group

Experimental

Salmon followed by YSS

干预措施: YSS (Other)

Salmon/YSS group

Experimental

Salmon followed by YSS

干预措施: Salmon (Other)

结局指标

主要结局

Changes in hemostatic status assessed by immunoassay method

时间窗: 8 weeks

Hemostatic markers including vWF-A2 and CD62b (p-selectin) in pg/mL are evaluated.

次要结局

  • Changes in lipid and glucose profiles analysed by medical diagnostic laboratory(8 weeks)
  • Changes in renal function analysed by medical diagnostic laboratory(8 weeks)
  • Changes in body mass index (BMI)(8 weeks)
  • Changes in blood pressure(8 weeks)
  • Changes in liver enzymes analysed by medical diagnostic laboratory(8 weeks)

研究者

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

Dr. Loh Su Peng

Associate Professor

Universiti Putra Malaysia

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