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

Not Applicable

• Conditions: Hyperhomocysteinemia
• Interventions: Dietary Supplement: supplementation of compound nutrients; Dietary Supplement: placebo control

• Registration Number: NCT03720249
• Lead Sponsor: Huilian Zhu

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-24
• Study First Submitted QC: 2018-10-24
• Study First Posted: 2018-10-25
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-12
• Last Update Posted: 2019-05-14
• Study Start: 2019-05-20
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
supplementation of compound nutrients	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.
placebo control	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

SunYat-sen University; 🇨🇳 Guangzhou, Guangdong, China