Blood Pressure, Cardiovascular Diseases, Hypertension
Conditions
Keywords
hydrogen nanobubbles, cardiovascular physiology, health-related quality of life, blood pressure, myocardial relaxation
Brief summary
The goal of this clinical trial is to learn if intravenous hydrogen nanobubbles (HNBs) improve cardiovascular function and quality of life in adults. It will also explore the dose-dependent effects of HNBs when given through IV infusion. The main questions it aims to answer are: 1. Do HNBs improve heart function and blood vessel health (e.g., blood pressure, ejection fraction, flow-mediated dilation)? 2. How do different doses of HNBs affect quality of life as measured by the SF-36 questionnaire? 3. Are there any safety or tolerability concerns with intravenous HNBs? Researchers will compare different doses of HNBs (5 mL to 25 mL) to a placebo (normal saline) to evaluate their physiological and psychological effects. Participants will: 1. Receive intravenous infusions twice a week for 5 weeks (10 sessions in total) 2. Be assigned randomly to one of six groups (five different HNB doses or placebo) 3. Complete quality-of-life questionnaires and undergo cardiovascular and lab tests before and after the intervention
Detailed description
This clinical study explored whether intravenous hydrogen nanobubbles (HNBs) can improve heart health and quality of life. HNBs are microscopic hydrogen gas bubbles that may help reduce oxidative stress and inflammation-two major contributors to cardiovascular disease. The research aimed to assess how different doses of HNBs affect blood pressure, heart function, blood vessel health, and overall well-being. A total of 52 healthy adults aged 18-65 took part in the trial. They were randomly assigned to receive either normal saline (as a placebo) or saline mixed with varying doses of HNBs (5-25 mL). Each participant received 10 intravenous infusions over 5 weeks, with health checks before and after. Researchers used physical exams, blood tests, heart scans, and a standardized questionnaire (SF-36) to track changes in cardiovascular function and quality of life. This study helps lay the groundwork for future research into non-drug therapies using nanotechnology. If proven effective, HNBs could become a novel, low-risk treatment option for people with high blood pressure, heart stress, or chronic inflammation-ultimately supporting both physical and emotional well-being.
Interventions
OTHERintravenous infusion of hydrogen nanobubbles (HNB) administered twice weekly over a 5-week period
This study investigated a novel intervention using intravenous hydrogen nanobubbles (HNBs), which are microscopic hydrogen gas bubbles encapsulated in liquid, offering enhanced stability, deep tissue penetration, and sustained antioxidant and anti-inflammatory effects. Unlike other hydrogen therapies (such as inhalation or hydrogen-rich water), this method delivers HNBs directly into the bloodstream. Participants were randomized into six groups: one control group receiving saline and five intervention groups receiving escalating doses of HNBs (5-25 mL) over 10 intravenous infusions in 5 weeks. This intervention is distinct for its dose-response design, intravenous delivery, and combined evaluation of cardiovascular function and quality of life (SF-36)-a patient-centered approach not commonly found in similar studies.
Sponsors
Indonesia Molecule Institute
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants were assigned to one of the following six groups, with interventions administered intravenously twice a week over a 5-week period. Group A is the control group; intervention of intravenous 500 mL of normal saline (NS) for 10 sessions over 5 weeks. Group B; intervention of 5 mL of HNB in NS i.v. for 10 sessions over 5 weeks. Group C with 10 mL HNB, group D 15 mL, group E 20mL, and group F with 25mL HNB, all done in 10 sessions over 5 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Participants will be eligible for inclusion in the study if they meet all of the following criteria: 1. Aged between 18 and 65 years at the time of screening. 2. Demonstrated stable health condition, as determined by medical history and baseline clinical evaluation. 3. Willing and able to provide written informed consent. 4. Able to comply with study procedures and agree to maintain normal daily activities and dietary patterns throughout the study period.
Exclusion criteria
Participants will be excluded from the study if they meet any of the following criteria: 1. Known or suspected hypersensitivity to hydrogen or hydrogen-based products. 2. Current participation in another interventional clinical trial. 3. Diagnosed with advanced or uncontrolled cardiovascular, renal, or hepatic disease. 4. Any other medical or psychological condition that, in the opinion of the investigators, could compromise the participant's safety or the integrity of the study data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Physiology | From enrollment to the end of treatment at 6 weeks | Primary cardiovascular function outcomes included systolic and diastolic blood pressure, measured in millimeters of mercury (mmHg); heart rate, expressed in beats per minute (bpm); and left ventricular ejection fraction (LVEF), reported as a percentage. Diastolic function was assessed through early diastolic mitral inflow velocity (EVel), lateral mitral annular velocity (ELat), and septal mitral annular velocity (ESep), all expressed in meters per second (m/s). Left Ventricular Mass divided by Body Surface Area (BSA) to report Left Ventricular Mass Index in (g/m²), relative wall thickness (RWT), presented as a unitless ratio; tricuspid annular plane systolic excursion (TAPSE), interventricular septal thickness in diastole (IVSd), left ventricular internal dimension in diastole (LVIDd), and left ventricular posterior wall thickness in diastole (LVPWD), all reported in centimeters (cm).Flow-mediated dilation (FMD) (% change in vessel diameter) |
| Health-Related Quality of Life (HRQoL) | From enrollment to the end of treatment at 6 weeks | The study evaluated health-related quality of life (HRQoL) using the 36-Item Short Form Health Survey (SF-36), a validated instrument consisting of eight distinct domains: General Health (GH), Physical Functioning (PF), Role Limitations due to Physical Health (PH), Bodily Pain (BP), Vitality (VT), Social Functioning (SF), Role Limitations due to Emotional Problems (EL), and Mental Health (MH). Each domain was treated as a separate outcome measure and scored individually on a scale from 0 to 100, where higher scores reflect better health status in that specific domain. In accordance with reporting standards, each SF-36 domain was analyzed and reported independently, rather than being combined into a single summary score. Although all domains share the same unit (0-100 scale), they assess different dimensions of physical and mental well-being and are therefore presented as distinct outcome variables. |
Countries
Indonesia
Outcome results
None listed