Efficacy and Safety of Portable Hydrogen Rich Water Machine is Used for Adjuvant Treatment of Patients With Hyperlipidemia

NCT06301451 | Recruiting

• 1 other identifier: XD2021-1
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperlipidemias

Keywords

Hydrogen; Hydrogen rich water; Efficacy and safety; Adjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in LDL-C 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.

  At 3 months of intervention.

Secondary Outcomes (50)

• Absolute change from baseline in LDL-C 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 1 month of intervention.

  at 1 month of intervention.

• Percent change from baseline in LDL-C at 6 months of intervention.

  at 6 months of intervention.

• Absolute change from baseline in LDL-C at 6 months of intervention.

  at 6 months of intervention.

Study Arms (2)

General dietary guidance and hydrogen water group

EXPERIMENTAL

Trial group is treated with general dietary guidance and hydrogen water prepared by portable hydrogen rich water machine.

Device: General dietary guidance and hydrogen water prepared by portable hydrogen rich water machine

General dietary guidance group

NO INTERVENTION

Control group is treated with general dietary guidance.

Interventions

General dietary guidance and hydrogen water prepared by portable hydrogen rich water machine DEVICE

The trial group drink the hydrogen water prepared by the experimental equipment on the basis of receiving general dietary guidance.

General dietary guidance and hydrogen water group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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: 1. Bilateral carotid artery color Doppler shows no plaque formation, and 2.6 ≤ LDL-C \< 4.92mmol/L; 2. Bilateral or unilateral neck Arterial plaque formation, and 2.6≤LDL-C\<3.4mmol/L;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Jia: lead

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jia Sun, MD,PhD

  Zhujiang Hospital

  STUDY CHAIR

• Hong Chen, MD,PhD

  Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

• Li Cong, MD,PhD

  Fifth Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

• Lihong Wang, MD,PhD

  First Affiliated Hospital of Jinan University

  PRINCIPAL INVESTIGATOR

• Xiuwei Zhang, MD,PhD

  Dongguan People's Hospital

  PRINCIPAL INVESTIGATOR

• Yi Shu, MD,PhD

  Foshan Nanhai District People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jia Sun, MD,PhD

CONTACT

0086-13751822925; sunjia@smu.edu.cn

Guanghang Xie, B.S.Med

CONTACT

0086-14777563072; 815470786@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice-Chairman of the Department of Endocrinology and Metabolism#Chief Physician#Associate Professor#Doctor Supervisor of Endocrinology

Model Details: 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.

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: March 8, 2024
• Study Start: April 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)