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

NCT03720249 — Not applicable, Unknown, 100 participants, Huilian Zhu

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

Registry	NCT03720249
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, basic science
Enrollment	100 (Estimated)
Sponsor	Huilian Zhu (Other)
Conditions	Hyperhomocysteinemia
Interventions	supplementation of compound nutrients, placebo control (Dietary supplement)
Dates	start 2019-05-20 (estimated), primary completion 2022-12-31 (estimated), completion 2022-12-31 (estimated), first posted 2018-10-25, last updated 2019-05-14
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
supplementation of compound nutrients	Experimental	Dietary Supplement: 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 comparator	Dietary Supplement: 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.

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

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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.

+Locations (1)

Facility	City	Country	Status
SunYat-sen University	Guangzhou, Guangdong	China

+Publications

Results publication: Lu XT, Wang YN, Mo QW, Huang BX, Wang YF, Huang ZH, Luo Y, Maierhaba W, He TT, Li SY, Huang RZ, Yang MT, Liu XZ, Liu ZY, Chen S, Fang AP, Zhang XG, Zhu HL. Effects of low-dose B vitamins plus betaine supplementation on lowering homocysteine concentrations among Chinese adults with hyperhomocysteinemia: a randomized, double-blind, controlled preliminary clinical trial. Eur J Nutr. 2023 Jun;62(4):1599-1610. doi: 10.1007/s00394-023-03087-y. Epub 2023 Jan 30. PMID 36717385

+Investigators

Huilian Zhu, professor, Study chair, Sun Yat-sen University