Effects of Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults With Hyperhomocysteinemia

Study Overview
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Brief Summary
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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.

Official Title
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Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults With Hyperhomocysteinemia: a Randomized Double-blind Control Trial

Conditions
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Hyperhomocysteinemia

Intervention / Treatment
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* Dietary Supplement: supplementation of compound nutrients
* Dietary Supplement: placebo control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: supplementation of compound nutrients<br>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. | Dietary Supplement: supplementation of compound nutrients<br>* Betaine、 (6S)-5-methyltetrahydrofolic acid、vitamin B6、vitamin B12 and zinc per day orally for 12 weeks.<br>* Other names: Betaine、 (6S)-5-methyltetrahydrofolic acid、vitamin B6、vitamin B12 and zinc supplement;|
| Placebo Comparator: placebo control<br>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. | Dietary Supplement: placebo control<br>* The placebo is an excipient and the color, flavor, shape, taste and weight are same with the tablet of supplement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |