Efficacy and Safety of Portable Hydrogen Rich Water Machine is Used for Adjuvant Treatment of Patients With Hyperlipidemia: #A Prospective, Multicenter, Follow-up Machine-controlled, Standard-controlled Clinical Trials
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Percent change from baseline in LDL-C at 3 months of intervention.
研究概览
简要总结
In the past 30 years, the blood lipid level of the Chinese population has gradually increased, and the prevalence of dyslipidemia patients has increased significantly. Hyperlipidemia is a disease caused by abnormal blood lipid levels, also known as abnormal lipid metabolism. Common clinical indicators include total cholesterol (TC), triglyceride (TG), low-density lipoprotein (LDL) and high-density lipoprotein ( HDL).The number of patients with abnormal blood lipid levels in China accounts for as high as 40% of the total. It is estimated that between 2010 and 2030,cardiovascular disease events will increase by 9.2 million, which seriously endangers human health and becomes a high risk factor for various cardiovascular diseases, such as atherosclerosis. One of the pathological foundations of atherosclerosis is that abnormal lipid levels in the body cause a large amount of lipid to be deposited in the arterial endothelial matrix, which is phagocytosed by smooth muscle and macrophages to form foam cells.
Hydrogen, the lightest and smallest molecular gas in the atmosphere, is considered a novel antioxidant that reduces oxidative stress. Accumulating evidence from various biomedical fields in clinical studies and experimental models of many diseases suggests that hydrogen inhalation or drinking hydrogen-containing solutions can be used as a therapeutic strategy. Due to the special physical properties of hydrogen gas that is easy to diffuse, hydrogen molecules can penetrate cell membranes to reach organelles and cell nuclei. Hydrogen's moderate reducing properties make it effective in reducing cytotoxicity, protecting nuclear DNA and mitochondria, and reducing the risk of lifestyle-related diseases and cancer.
In addition, hydrogen intake can reduce oxidative stress, improve cellular function, and reduce chronic inflammation, which are associated with the pathology and etiology of hyperlipidemia and other related diseases. Molecular hydrogen can regulate important metabolic functions such as signal transduction, protein phosphorylation, miRNA expression, and autophagy. Studies have shown that intake of hydrogen water in APOE knockout mice can reduce serum total cholesterol and low-density lipoprotein levels and prevent the progression of atherosclerosis. A study by Song et al. in 2013 included 20 subjects who drank 0.9 to 1 L of hydrogen-rich water per day for 10 weeks, and the subjects' LDL-C levels decreased significantly before and after treatment. Another study showed that subjects with underlying lipid metabolism abnormalities were treated with high-concentration hydrogen water (5.5mmol/d) for up to 24 weeks, and serum total cholesterol and low-density lipoprotein levels were significantly reduced. Protein function and redox status (eg, increased serum superoxide dismutase and decreased malondialdehyde) were improved, markers of inflammation (eg, serum tumor necrosis factor-alpha) decreased and fasting blood glucose decreased. At present, the research on the treatment of hyperlipidemia with hydrogen water is very limited. The portable hydrogen water hydrogen machine used in this study has passed the registration test of the Guangdong Provincial Medical Device Quality Supervision and Inspection Institute. In order to evaluate the use of the portable hydrogen water hydrogen machine for hyperlipidemia The efficacy and safety of adjuvant therapy in patients, this clinical trial is specially carried out.
详细描述
This study is a prospective, multicenter, randomized, standard-controlled clinical trial with an expected enrollment of 180 subjects. The subjects who meet the conditions of this trial will be randomly divided into the experimental group and the control group according to 2:1. The experimental group drank hydrogen water prepared by the experimental device on the basis of general dietary guidance, while the control group only received general dietary guidance, and the diet and lifestyle of each subject remained basically unchanged during the treatment period. This clinical trial is equipped with a nutritionist, who will provide general dietary guidance to the subjects before the formal trial. The subjects in the experimental group also need to receive additional training on the use of experimental equipment. During the research process, subjects need to fill in the online electronic diary card 3 days a week (2 days on weekdays and 1 day on weekends), and take photos and upload the diet on the day, and the dietitian will monitor the subjects' diet every week. Evaluate and give guidance; high-fat and high-sugar foods during the trial period need to be specially recorded in the electronic diary card, and daily hydrogen water intake, weekly tobacco, alcohol intake and physical activity are also recorded in the electronic diary card. On the 14th day of the treatment period, the subjects in the experimental group were followed up by telephone, mainly to investigate the use of the experimental equipment. At 1 month, 3 months, and 6 months after the start of treatment, the subjects returned to the hospital for follow-up, received corresponding laboratory tests, and evaluated the triglyceride levels of the experimental group and the control group at 1 month, 3 months, and 6 months. Absolute and percent change from baseline in lipids, total cholesterol, HDL cholesterol, LDL cholesterol, non-HDL cholesterol, small and dense LDL, apolipoprotein B, TNF-alpha , to study product performance, as well as adverse events during treatment, serious adverse events, and device defects to evaluate the efficacy and safety of portable hydrogen water hydrogen generators.
The statistical methods are as follow:
1.General Principles of Statistical Analysis:
- Test standard: α=0.05 two-sided test is adopted uniformly, and P≤0.05 is considered to be statistically significant.
- Measurement data: We use mean ± standard deviation to represent measurement data, and if necessary, give data such as minimum value, maximum value, P25, median and P75. When comparing before and after treatment between or within the two groups, the variables are first tested for normality. When obeying normal distribution, use group t-test or paired t-test; when obeying non-normal distribution, use nonparametric statistical methods such as Wilcoxon rank sum test or Signed Rank test. If the influence of center or other factors is considered, use analysis of covariance.
- Count data: We use the frequency and its percentage to statistically describe the count data. The chi-square test, Fisher's exact test or Wilcoxon rank-sum test are used for comparison between two groups or within groups before and after treatment; if the influence of center or other factors is considered, the CMH chi-square test adjusted for center effect was used.
- Subgroup analysis: We do not exclude subgroup analyses when necessary.
2.Statistical analysis crowd:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 (inclusive), gender is not limited;
- •Subjects with clinical diagnosis of hyperlipidemia;
- •The subjects' fasting LDL-C and carotid artery color Doppler ultrasound meet one of the following requirements:
- •Bilateral carotid artery color Doppler shows no plaque formation, and 2.6 ≤ LDL-C < 4.92mmol/L;
- •Bilateral or unilateral neck Arterial plaque formation, and 2.6≤LDL-C<3.4mmol/L;
- •18.5 kg/m2≤BMI≤35 kg/m2, Body mass index (BMI) is calculated by dividing body weight (kg) by the square of height (m2);
- •Subjects who are willing to participate in the trial and sign informed consent.
排除标准
- •Secondary hyperlipidemia caused by systemic diseases (such as nephrotic syndrome, hypothyroidism, systemic lupus erythematosus, glycogen storage disease, liver disease or renal failure, etc.);
- •Fasting triglycerides > 5.6 mmol/L;
- •Diabetic patients;
- •Those who plan to undergo bariatric surgery (gastric retraction, gastric bypass, gastric banding, etc.) during the study period;
- •Have taken or plan to take lipid-lowering drugs within the last 8 weeks (eg, statins, cholesterol absorption inhibitors, probucol, bile acid sequestrants, fibrates, proprotein convertase subtilisin 9 (PCSK9) ) inhibitors, Xuezhikang and Chinese patent medicines with lipid-lowering effect, etc.) who intervene;
- •Those who have taken or plan to take lipid-lowering drugs within the last 8 weeks (eg, statins, cholesterol absorption inhibitors, probucol, bile acid sequestrants, fibrates, proprotein convertase subtilisin 9 (PCSK9) inhibitors, Xuezhikang and Chinese patent medicines with lipid-lowering effect, etc.);
- •Subjects who have used heparin, thyroxine treatment drugs, diuretics, phenothiazines, beta-blockers, adrenal corticosteroids and certain contraceptives in the past 8 weeks, which may affect blood lipid metabolism;
- •Combined with malignant tumor or mental disorder;
- •Accompanied by severe cardiovascular and cerebrovascular diseases, liver and kidney function damage (NYHA grade greater than or equal to 3, ALT or AST > 3 times the upper limit of normal, Cr > 1.5 times the upper limit of normal);
- •Those who have participated in clinical trials of other drugs or medical devices within 3 months;
- •Those who plan to become pregnant, are pregnant or are breastfeeding during the study period and those who cannot take contraceptive measures;
- •Patients deemed unsuitable for participation in this study by the investigator.
研究组 & 干预措施
General dietary guidance and hydrogen water group
Trial group is treated with general dietary guidance and hydrogen water prepared by portable hydrogen rich water machine.
干预措施: General dietary guidance and hydrogen water prepared by portable hydrogen rich water machine (Device)
General dietary guidance group
Control group is treated with general dietary guidance.
结局指标
主要结局
Percent change from baseline in LDL-C at 3 months of intervention.
时间窗: At 3 months of intervention.
LDL-C will be uniformly implemented in the laboratories of each research central hospital.And uniformly use "mmol/L" as the unit.
次要结局
- Percent change from baseline in total cholesterol at 1 month of intervention.(At 1 month of intervention.)
- Absolute change from baseline in non-HDL cholesterol at 3 months of intervention.(At 3 months of intervention.)
- Percent change from baseline in non-HDL cholesterol at 6 months of intervention.(At 6 months of intervention.)
- Absolute change from baseline in small and dense LDL at 1 month of intervention.(At 1 month of intervention.)
- Percent change from baseline in small and dense LDL at 3 months of intervention.(At 3 months of intervention.)
- Percent change from baseline in small and dense LDL at 6 months of intervention.(At 6 months of intervention.)
- Percent change from baseline in LDL-C at 6 months of intervention.(at 6 months of intervention.)
- Absolute change from baseline in total cholesterol at 6 months of intervention.(At 6 months of intervention.)
- Percent change from baseline in HDL cholesterol at 1 month of intervention.(At 1 month of intervention.)
- Percent change from baseline in apolipoprotein B at 1 month of intervention.(At 1 month of intervention.)
- Absolute change from baseline in TNF-alpha at 3 months of intervention.(At 3 months of intervention.)
- Absolute change from baseline in LDL-C at 3 months of intervention.(At 3 months of intervention.)
- Percent change from baseline in triglycerides at 6 months of intervention.(At 6 months of intervention.)
- Absolute change from baseline in triglycerides at 6 months of intervention.(At 6 months of intervention.)
- Absolute change from baseline in total cholesterol at 1 month of intervention.(At 1 month of intervention.)
- Absolute change from baseline in total cholesterol at 3 months of intervention.(At 3 months of intervention.)
- Absolute change from baseline in HDL cholesterol at 1 month of intervention.(At 1 month of intervention.)
- Absolute change from baseline in small and dense LDL at 3 months of intervention.(At 3 months of intervention.)
- Percent change from baseline in apolipoprotein B at 3 months of intervention.(At 3 months of intervention.)
- Absolute change from baseline in apolipoprotein B at 3 months of intervention.(At 3 months of intervention.)
- Percent change from baseline in LDL-C at 1 month of intervention.(at 1 month of intervention.)
- Absolute change from baseline in LDL-C at 6 months of intervention.(at 6 months of intervention.)
- Percent change from baseline in triglycerides at 1 month of intervention.(At 1 month of intervention.)
- Percent change from baseline in triglycerides at 3 months of intervention.(At 3 months of intervention.)
- Absolute change from baseline in triglycerides at 3 months of intervention.(At 3 months of intervention.)
- Percent change from baseline in total cholesterol at 3 months of intervention.(At 3 months of intervention.)
- Percent change from baseline in HDL cholesterol at 3 months of intervention.(At 3 months of intervention.)
- Absolute change from baseline in HDL cholesterol at 3 months of intervention.(At 3 months of intervention.)
- Percent change from baseline in non-HDL cholesterol at 1 month of intervention.(At 1 month of intervention.)
- Absolute change from baseline in non-HDL cholesterol at 1 month of intervention.(At 1 month of intervention.)
- Absolute change from baseline in non-HDL cholesterol at 6 months of intervention.(At 6 months of intervention.)
- Absolute change from baseline in small and dense LDL at 6 months of intervention.(At 6 months of intervention.)
- Absolute change from baseline in apolipoprotein B at 1 month of intervention.(At 1 month of intervention.)
- Percent change from baseline in TNF-alpha at 3 months of intervention.(At 3 months of intervention.)
- Percent change from baseline in TNF-alpha at 6 months of intervention.(At 6 months of intervention.)
- Severe Adverse Event (SAE) Frequency(At 6 months of intervention.)
- Percent change from baseline in apolipoprotein B at 6 months of intervention.(At 6 months of intervention.)
- Absolute change from baseline in apolipoprotein B at 6 months of intervention.(At 6 months of intervention.)
- Adverse Event (AE) Frequency(At 6 months of intervention.)
- Device deficiency rate(At 6 months of intervention.)
- Absolute change from baseline in triglycerides at 1 month of intervention.(At 1 month of intervention.)
- Absolute change from baseline in LDL-C at 1 month of intervention.(at 1 month of intervention.)
- Percent change from baseline in total cholesterol at 6 months of intervention.(At 6 months of intervention.)
- Percent change from baseline in HDL cholesterol at 6 months of intervention.(At 6 months of intervention.)
- Absolute change from baseline in HDL cholesterol at 6 months of intervention.(At 6 months of intervention.)
- Percent change from baseline in non-HDL cholesterol at 3 months of intervention.(At 3 months of intervention.)
- Percent change from baseline in small and dense LDL at 1 month of intervention.(At 1 month of intervention.)
- Percent change from baseline in TNF-alpha at 1 month of intervention.(At 1 month of intervention.)
- Absolute change from baseline in TNF-alpha at 1 month of intervention.(At 1 month of intervention.)
- Absolute change from baseline in TNF-alpha at 6 months of intervention.(At 6 months of intervention.)
研究者
Sun Jia
Vice-Chairman of the Department of Endocrinology and Metabolism#Chief Physician#Associate Professor#Doctor Supervisor of Endocrinology
Zhujiang Hospital