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

Hyperhomocysteinemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03720249
• Other study ID #: MN-2018-10
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2019
• Source: Sun Yat-sen University
• Contact: Huilian Zhu, professor
• Phone: +86 20 87331811
• Email: zhuhl[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Hyperhomocysteinemia

Intervention

Dietary Supplement:
• supplementation of compound nutrients
Betaine? (6S)-5-methyltetrahydrofolic acid?vitamin B6?vitamin B12 and zinc per day orally for 12 weeks.
• placebo control
The placebo is an excipient and the color, flavor, shape, taste and weight are same with the tablet of supplement.

Locations

Country	Name	City	State
China	SunYat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Huilian Zhu

Country where clinical trial is conducted

China, 

Outcome

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