IV Hydrogen Nanobubbles for Cardiac Function and QoL

NCT ID: NCT07085637

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-19
• Study Completion Date: 2022-11-04

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.

Conditions

Cardiovascular Diseases; Hypertension; Blood Pressure

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Different dosage types

This study was designed as a randomized, single-blind, dose-response clinical trial consisting of six distinct arms. The first arm served as the control group, where participants received 500 mL of normal saline without any hydrogen nanobubbles, functioning as a placebo. The remaining five arms were intervention groups that received intravenous infusions of hydrogen nanobubbles (HNBs) at different doses. Specifically, participants in Arm B received 5 mL of HNB, Arm C received 10 mL of HNB, Arm D received 15 mL of HNB, Arm E received 20 mL of HNB, and Arm F received 25 mL of HNB, with each dose diluted in normal saline.

All participants underwent a total of 10 infusion sessions over a period of 5 weeks, receiving treatments twice weekly. The study was conducted under single-blind conditions. This multi-arm design allowed the researchers to systematically evaluate the dose-dependent effects of HNB therapy on cardiovascular function, blood biomarkers, and health-related quality of life.

Group Type: EXPERIMENTAL

intravenous infusion of hydrogen nanobubbles (HNB) administered twice weekly over a 5-week period

Intervention Type: OTHER

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.

Interventions

intravenous 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia Molecule Institute

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Indonesia Molecule Institute

Malang, East Java, Indonesia

Countries

Indonesia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

No. 410/KPEK-POLKESMA/2022

Identifier Type: -

Identifier Source: org_study_id