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临床试验/NCT03844958
NCT03844958已完成不适用

Effect of Consuming Red Furu On Serum Vitamin B12, Homocysteine And Other Cardio-Metabolic Risk Factors In Healthy Young Volunteers: A Randomized Controlled Trial

Zhejiang University2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2017年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
23
试验地点
2
主要终点
Serum Vitamin B12

研究概览

简要总结

The aim of the present study is to investigate the effect of red furu (Chinese fermented soybean product) consumption on serum vitamin B12, Homocysteine concentration and other cardio-metabolic risk factors in healthy young volunteers.

详细描述

The study will apply the parallel study method and participants will be randomized into two groups. In the randomized controlled clinical trial, twenty-three healthy young volunteers (11 females and 12 males, aged 19-39 years) were recruited from Zhejiang University, China. They were randomly assigned to two groups of either red furu (n=11, 5 females and 6 males) or tofu (n=12, 6 females and 6 males). Volunteers consumed a provided meal, either 50 g of red furu or tofu with two slices of bread for 1 day breakfast meal. Volunteers also recorded their normal dietary intake during the 3 days trial period using provided self-report food diary. Fasting blood sample was drawn at 0h, 24h and 72h. Serum VB12, Hcy and other cardio-metabolic risk factors were measured by standard methods.

Test Meals:

Red Furu Group: 50 g of red furu with 2 slices of bread. Tofu Group: 50 g of plain tofu eaten with 2 slices of bread. Volunteers will refrain from consumption of fermented products 1 week prior to the study. Thereafter subject feed on control diet and intervention diet for 1 day. Volunteers' normal diets and test meals will be recorded on a self-administered questionnaire, followed by testing serum vitamin B12, Homocysteine and other biochemical parameters.

5-10 mL blood will be collected per session. Blood will be collected: 3 times (0h-24h-72h).Participants will be asked to fast for 10-12 hours prior to the blood draw.

研究设计

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

入排标准

年龄范围
20 Years 至 39 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •20-39 Years
  • •All Races

排除标准

  • •Taking antibiotics or vitamin B12 supplements within 1 month prior to enrollment

研究组 & 干预措施

Red Furu

Experimental

Volunteer was randomized into group red furu

干预措施: Red Furu (Other)

Red Furu

Experimental

Volunteer was randomized into group red furu

干预措施: Tofu (Other)

Fresh Tofu

Experimental

Volunteer was randomized into group tofu

干预措施: Red Furu (Other)

Fresh Tofu

Experimental

Volunteer was randomized into group tofu

干预措施: Tofu (Other)

结局指标

主要结局

Serum Vitamin B12

时间窗: 0-24-72 Hours

Serum vitamin B12 concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd

Serum Homocysteine

时间窗: 0-24-72 Hours

Serum homocysteine concentration was measured by a clinical chemistry analyzer by Hangzhou Golden Field Medical Laboratory Co., Ltd

次要结局

  • High-density cholesterol(0-24-72 Hours)
  • Low-density cholesterol(0-24-72 Hours)
  • Serum Ferritin(0-24-72 Hours)
  • Glucose(0-24-72 Hours)
  • Total cholesterol(0-24-72 Hours)
  • Triglyceride(0-24-72 Hours)
  • Serum Folate(0-24-72 Hours)
  • Serum Iron(0-24-72 Hours)

研究者

发起方
Zhejiang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Duo li

Professor

Zhejiang University

研究点 (2)

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