低剂量 B 族维生素联合甜菜碱补充剂对降低高同型半胱氨酸血症中国成年人同型半胱氨酸水平的影响：一项随机、双盲、对照的初步临床试验。

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.

机构信息

Department of Nutrition, School of Public Health, Sun Yat-sen University, 74 Zhong Shan Road 2, Guangzhou, 510080, Guangdong, China.

Guangdong Provincial Key Laboratory of Food, Nutrition and Health, School of Public Health, Sun Yat-sen University, Guangzhou, Guangdong, China.

出版信息

Eur J Nutr. 2023 Jun;62(4):1599-1610. doi: 10.1007/s00394-023-03087-y. Epub 2023 Jan 30.

DOI:10.1007/s00394-023-03087-y

PMID:36717385

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9886420/

Abstract

PURPOSE

To test the hypothesis that daily supplementation with low-dose B vitamins plus betaine could significantly reduce plasma homocysteine concentrations in Chinese adults with hyperhomocysteinemia and free from background mandatory folic acid fortification.

METHODS

One hundred apparently healthy adults aged 18-65 years with hyperhomocysteinemia were recruited in South China from July 2019 to June 2021. They were randomly assigned to either the supplement group (daily supplementation: 400 μg folic acid, 8 mg vitamin B, 6.4 μg vitamin B and 1 g betaine) or the placebo group for 12 weeks. Fasting venous blood was collected at baseline, week 4 and week 12 to determine the concentrations of homocysteine, folate, vitamin B and betaine. Generalized estimation equations were used for statistical analysis.

RESULTS

Statistically significant increments in blood concentrations of folate, vitamin B and betaine after the intervention in the supplement group indicated good participant compliance. At baseline, there were no significant differences in plasma homocysteine concentration between the two groups (P = 0.265). After 12-week supplementation, compared with the placebo group, there was a significant reduction in plasma homocysteine concentrations in the supplement group (mean group difference - 3.87; covariate-adjusted P = 0.012; reduction rate 10.1%; covariate-adjusted P < 0.001). In the supplement group, the decreased concentration of plasma homocysteine was associated with increments of blood concentrations of both folate (β = -1.680, P = 0.004) and betaine (β = -1.421, P = 0.020) after 12 weeks of supplementation.

CONCLUSIONS

Daily supplementation with low-dose B vitamins plus betaine for 12 weeks effectively decreased plasma homocysteine concentrations in Chinese adults with hyperhomocysteinemia.

TRIAL REGISTRATION

This trial was registered at clinicaltrials.gov as NCT03720249 on October 25, 2018. Website: https://clinicaltrials.gov/ct2/show/NCT03720249 .

摘要

目的

检验以下假设，即每日补充低剂量维生素 B 族和甜菜碱可显著降低中国高同型半胱氨酸血症且未进行强制性叶酸强化的成年人的血浆同型半胱氨酸浓度。

方法

2019 年 7 月至 2021 年 6 月，在中国南方招募了 100 名年龄在 18-65 岁之间的有明显高同型半胱氨酸血症的健康成年人。他们被随机分配到补充组（每日补充：400μg 叶酸、8mg 维生素 B、6.4μg 维生素 B 和 1g 甜菜碱）或安慰剂组，干预时间为 12 周。在基线、第 4 周和第 12 周采集空腹静脉血，以确定同型半胱氨酸、叶酸、维生素 B 和甜菜碱的浓度。采用广义估计方程进行统计分析。

结果

补充组在干预后血液中叶酸、维生素 B 和甜菜碱浓度显著增加，表明参与者依从性良好。在基线时，两组间血浆同型半胱氨酸浓度无显著差异（P=0.265）。经过 12 周的补充后，与安慰剂组相比，补充组的血浆同型半胱氨酸浓度显著降低（平均组间差异-3.87；协变量调整后的 P=0.012；降低率 10.1%；协变量调整后的 P<0.001）。在补充组中，血浆同型半胱氨酸浓度的降低与叶酸（β=-1.680，P=0.004）和甜菜碱（β=-1.421，P=0.020）的血液浓度增加相关，这些变化发生在补充 12 周后。