protocolSection identificationModule nctId: NCT06301451, orgStudyIdInfo id: XD2021-1, briefTitle: Efficacy and Safety of Portable Hydrogen Rich Water Machine is Used for Adjuvant Treatment of Patients With Hyperlipidemia, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-04-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Sun Jia, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Hyperlipidemias, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: It is estimated that 180 subjects will be enrolled and randomly divided into the experimental group and the control group according to 2:1. During the observation period, the experimental group drink the hydrogen water prepared by the experimental equipment on the basis of the general dietary guidance, while the control group adopted the general dietary guidance. Every subject's diet and lifestyle remains largely unchanged during the treatment period., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: General dietary guidance and hydrogen water prepared by portable hydrogen rich water machine, outcomesModule primaryOutcomes measure: Percent change from baseline in LDL-C at 3 months of intervention., secondaryOutcomes measure: Absolute change from baseline in LDL-C at 3 months of intervention., secondaryOutcomes measure: Percent change from baseline in LDL-C at 1 month of intervention., secondaryOutcomes measure: Absolute change from baseline in LDL-C at 1 month of intervention., secondaryOutcomes measure: Percent change from baseline in LDL-C at 6 months of intervention., secondaryOutcomes measure: Absolute change from baseline in LDL-C at 6 months of intervention., secondaryOutcomes measure: Percent change from baseline in triglycerides at 1 month of intervention., secondaryOutcomes measure: Absolute change from baseline in triglycerides at 1 month of intervention., secondaryOutcomes measure: Percent change from baseline in triglycerides at 3 months of intervention., secondaryOutcomes measure: Absolute change from baseline in triglycerides at 3 months of intervention., secondaryOutcomes measure: Percent change from baseline in triglycerides at 6 months of intervention., secondaryOutcomes measure: Absolute change from baseline in triglycerides at 6 months of intervention., secondaryOutcomes measure: Percent change from baseline in total cholesterol at 1 month of intervention., secondaryOutcomes measure: Absolute change from baseline in total cholesterol at 1 month of intervention., secondaryOutcomes measure: Percent change from baseline in total cholesterol at 3 months of intervention., secondaryOutcomes measure: Absolute change from baseline in total cholesterol at 3 months of intervention., secondaryOutcomes measure: Percent change from baseline in total cholesterol at 6 months of intervention., secondaryOutcomes measure: Absolute change from baseline in total cholesterol at 6 months of intervention., secondaryOutcomes measure: Percent change from baseline in HDL cholesterol at 1 month of intervention., secondaryOutcomes measure: Absolute change from baseline in HDL cholesterol at 1 month of intervention., secondaryOutcomes measure: Percent change from baseline in HDL cholesterol at 3 months of intervention., secondaryOutcomes measure: Absolute change from baseline in HDL cholesterol at 3 months of intervention., secondaryOutcomes measure: Percent change from baseline in HDL cholesterol at 6 months of intervention., secondaryOutcomes measure: Absolute change from baseline in HDL cholesterol at 6 months of intervention., secondaryOutcomes measure: Percent change from baseline in non-HDL cholesterol at 1 month of intervention., secondaryOutcomes measure: Absolute change from baseline in non-HDL cholesterol at 1 month of intervention., secondaryOutcomes measure: Percent change from baseline in non-HDL cholesterol at 3 months of intervention., secondaryOutcomes measure: Absolute change from baseline in non-HDL cholesterol at 3 months of intervention., secondaryOutcomes measure: Percent change from baseline in non-HDL cholesterol at 6 months of intervention., secondaryOutcomes measure: Absolute change from baseline in non-HDL cholesterol at 6 months of intervention., secondaryOutcomes measure: Percent change from baseline in small and dense LDL at 1 month of intervention., secondaryOutcomes measure: Absolute change from baseline in small and dense LDL at 1 month of intervention., secondaryOutcomes measure: Percent change from baseline in small and dense LDL at 3 months of intervention., secondaryOutcomes measure: Absolute change from baseline in small and dense LDL at 3 months of intervention., secondaryOutcomes measure: Percent change from baseline in small and dense LDL at 6 months of intervention., secondaryOutcomes measure: Absolute change from baseline in small and dense LDL at 6 months of intervention., secondaryOutcomes measure: Percent change from baseline in apolipoprotein B at 1 month of intervention., secondaryOutcomes measure: Absolute change from baseline in apolipoprotein B at 1 month of intervention., secondaryOutcomes measure: Percent change from baseline in apolipoprotein B at 3 months of intervention., secondaryOutcomes measure: Absolute change from baseline in apolipoprotein B at 3 months of intervention., secondaryOutcomes measure: Percent change from baseline in apolipoprotein B at 6 months of intervention., secondaryOutcomes measure: Absolute change from baseline in apolipoprotein B at 6 months of intervention., secondaryOutcomes measure: Percent change from baseline in TNF-alpha at 1 month of intervention., secondaryOutcomes measure: Absolute change from baseline in TNF-alpha at 1 month of intervention., secondaryOutcomes measure: Percent change from baseline in TNF-alpha at 3 months of intervention., secondaryOutcomes measure: Absolute change from baseline in TNF-alpha at 3 months of intervention., secondaryOutcomes measure: Percent change from baseline in TNF-alpha at 6 months of intervention., secondaryOutcomes measure: Absolute change from baseline in TNF-alpha at 6 months of intervention., secondaryOutcomes measure: Adverse Event (AE) Frequency, secondaryOutcomes measure: Severe Adverse Event (SAE) Frequency, secondaryOutcomes measure: Device deficiency rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhujiang Hospital of Southern Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Sun Jia, role: CONTACT, phone: 13751822925, geoPoint lat: 23.11667, lon: 113.25, hasResults: False