Hyperhomocysteinemia Clinical Trial
Official title:
Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults With Hyperhomocysteinemia: a Randomized Double-blind Control Trial
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. People aged 18-65 years. 2. The level of plasma homocysteine is 15-100µmol/L. 3. Free from products which could decrease plasma homocysteine for at least one month. 4. Willing to participate in the study, consume the test product and perform all measurements. Exclusion Criteria: 1. pregnant or lactating women. 2. severe diseases need to control. 3. people who unconsciousness and can not complete questionnaire. 4. long-term regular use of vitamin or mineral supplements. |
Country | Name | City | State |
---|---|---|---|
China | SunYat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Huilian Zhu |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | levels of homocysteine | At baseline, 4 weeks and 12 weeks, blood samples will be drawn and levels of homocysteine will be tested in two groups. | 12 weeks | |
Secondary | levels of 5-methyltetrahydrofolic acid, vitamin B6, vitamin B12 and betaine | At baseline, 4 weeks and 12 weeks, blood samples will be drawn and levels of 5-methyltetrahydrofolic acid, vitamin B6, vitamin B12 and betaine will be tested in two groups. | 12 weeks | |
Secondary | levels of s-adenosyl-methionine and s-adenosyl-homocysteine | At baseline, 4 weeks and 12 weeks, blood samples will be drawn and levels of s-adenosyl-methionine (SAM) and s-adenosyl-homocysteine (SAH) will be tested in two groups. | 12 weeks | |
Secondary | anthropomorphic measurements and blood biochemical markers | Anthropomorphic measurements such as height, weight, waist circumference, hip circumference, vascular endothelial function, cardiopulmonary function, body composition and so on, and blood biochemical markers such as overnight fasting serum total cholesterol (TC), triglyceride (TG), LDL cholesterol (LDLc), HDL cholesterol (HDLc), fasting blood glucose and so on will be measured. | 12 weeks |
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