Using hydrogen-rich water for treating high cholesterol

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

This study is testing if drinking hydrogen-rich water can help people with high cholesterol improve their lipid levels and overall health while they stick to their usual diet.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Zhujiang Hospital (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06301451 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of a portable hydrogen-rich water machine as an adjuvant treatment for patients with hyperlipidemia. It is a multicenter, randomized, controlled trial involving 180 participants who will be divided into an experimental group receiving hydrogen water and a control group receiving standard dietary guidance. Participants will maintain their usual diet and lifestyle while documenting their food intake and hydrogen water consumption through an electronic diary. The study aims to evaluate the impact of hydrogen-rich water on lipid levels and overall health.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with a clinical diagnosis of hyperlipidemia and specific LDL-C levels.

Not a fit: Patients with secondary hyperlipidemia due to systemic diseases or those with fasting triglycerides above 5.6 mmol/L may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel approach to managing hyperlipidemia and reducing the risk of cardiovascular diseases.

How similar studies have performed: While the use of hydrogen-rich water is a relatively novel approach, similar studies have shown promising results in improving lipid profiles.

Eligibility criteria

Inclusion Criteria:

* 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;
* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Guangzhou, Guangdong

• Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Hong Chen, MD,PhD — Zhujiang Hospital
• Study coordinator: Jia Sun, MD,PhD

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