Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults With Hyperhomocysteinemia: a Randomized Double-blind Control Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- levels of homocysteine
研究概览
简要总结
The purpose of this study is to determine whether supplementation of compound nutrients,including folic acid, vitamin B6, vitamin B12, betaine and zinc, will decrease the level of plasma homocysteine in Chinese adults with hyperhomocysteinemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People aged 18-65 years.
- •The level of plasma homocysteine is 15-100μmol/L.
- •Free from products which could decrease plasma homocysteine for at least one month.
- •Willing to participate in the study, consume the test product and perform all measurements.
排除标准
- •pregnant or lactating women.
- •severe diseases need to control.
- •people who unconsciousness and can not complete questionnaire.
- •long-term regular use of vitamin or mineral supplements.
研究组 & 干预措施
supplementation of compound nutrients
Betaine、(6S)-5-methyltetrahydrofolic acid、vitamin B6、vitamin B12 and zinc are provided as a 800mg tablet. And the tablet is orally taken once a day, four tablets at a time for 12 weeks.
干预措施: supplementation of compound nutrients (Dietary Supplement)
placebo control
The placebo is an excipient and the color, flavor, shape, taste and weight are same with the tablet of betaine、(6S)-5-methyltetrahydrofolic acid、vitamin B6、vitamin B12 and zinc supplement.
干预措施: placebo control (Dietary Supplement)
结局指标
主要结局
levels of homocysteine
时间窗: 12 weeks
At baseline, 4 weeks and 12 weeks, blood samples will be drawn and levels of homocysteine will be tested in two groups.
次要结局
- levels of 5-methyltetrahydrofolic acid, vitamin B6, vitamin B12 and betaine(12 weeks)
- levels of s-adenosyl-methionine and s-adenosyl-homocysteine(12 weeks)
- anthropomorphic measurements and blood biochemical markers(12 weeks)
研究者
Huilian Zhu
professor
Sun Yat-sen University