Hyperhomocysteinemia
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTsupplementation of compound nutrients
Betaine、 (6S)-5-methyltetrahydrofolic acid、vitamin B6、vitamin B12 and zinc per day orally for 12 weeks.
DIETARY_SUPPLEMENTplacebo control
The placebo is an excipient and the color, flavor, shape, taste and weight are same with the tablet of supplement.
Sponsors
Huilian Zhu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| levels of homocysteine | 12 weeks | At baseline, 4 weeks and 12 weeks, blood samples will be drawn and levels of homocysteine will be tested in two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| levels of 5-methyltetrahydrofolic acid, vitamin B6, vitamin B12 and betaine | 12 weeks | 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. |
| levels of s-adenosyl-methionine and s-adenosyl-homocysteine | 12 weeks | 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. |
| anthropomorphic measurements and blood biochemical markers | 12 weeks | 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. |
Countries
China
Contacts
Primary ContactHuilian Zhu, professor
Outcome results
None listed