NCT05325398

Brief Summary

Molecular hydrogen H2 acts as antioxidant which selectively reduces cytotoxic harmful reactive oxygen species ROS and concomitantly acts as biological messenger, which mediates several signaling pathways that play cytoprotective role in many human diseases. Due to their small size and high permeability, H2 is easily transportable into subcellular structures as mitochondria.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2021

Completed
11 months until next milestone

First Posted

Study publicly available on registry

April 13, 2022

Completed
Last Updated

April 13, 2022

Status Verified

April 1, 2022

Enrollment Period

7 months

First QC Date

May 14, 2021

Last Update Submit

April 6, 2022

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

Molecular hydrogeneffective antioxidantoxygen radicalsNAFLDmitochondria

Outcome Measures

Primary Outcomes (33)

  • Changes in body parameters: Weight in kilograms, height in meters, waist circumference in centimeters

    The following parameters will be measured for each proband before (time 0) and after the study (time 8 weeks): a) weight and height will be combined to report BMI in kg/m\^2, waist circumference in cm.

    8 weeks

  • Changes in blood parameters ALT

    ALT (alaninaminotransferase) ukat/L

    8 weeks

  • Changes in blood parameters AST

    AST (aspartataminotransferase) ukat/L

    8 weeks

  • Changes in blood parameters ALP

    ALP (alkaline phosphatase) ukat/L

    8 weeks

  • Changes in blood parameters GMT

    GMT (gamaglutamyltransferase) ukat/L

    8 weeks

  • Changes in blood parameters Albumin

    Albumin (g/L)

    8 weeks

  • Changes in blood parameters Cholinesterase

    Cholinesterase (ukat/L)

    8 weeks

  • Changes in blood parameters Bilirubin

    Bilirubin total (umol/L)

    8 weeks

  • Changes in blood parameters Glucose

    Glucose (mmol/L)

    8 weeks

  • Changes in blood parameters Cholesterol

    Cholesterol (mmol/L)

    8 weeks

  • Changes in blood parameters Triacylglycerol

    Triacylglycerol (mmol/L)

    8 weeks

  • Changes in blood parameters Insulin

    Insulin (mIU/L)

    8 weeks

  • Changes in blood parameters HOMA index

    HOMA index (calculation)

    8 weeks

  • Changes in blood parameters Leucocytes

    Leucocytes (x10\^9/L)

    8 weeks

  • Changes in blood parameters Hemoglobin

    Hemoglobin (g/L)

    8 weeks

  • Changes in blood parameters Platelets

    Platelets (x10\^9/L)

    8 weeks

  • Changes in blood parameters TBARS

    TBARS (μmol/L)

    8 weeks

  • Changes in blood parameters MDA

    MDA (malondialdehyde) (μmol/L)

    8 weeks

  • Changes in blood parameters LDH

    LDH (lactatdehydrogenase) (mU/mL)

    8 weeks

  • Changes in blood parameters MMP-2

    MMP-2 (matrix metalloproteinase2) (% of change)

    8 weeks

  • Changes in blood parameters MMP-9

    MMP-9 (matrix-metalloproteinase 9) (% of change)

    8 weeks

  • Changes in blood parameters 8-OHdG

    8-OHdG (8-hydroxy-2-deoxyguanosine) (ng/mL)

    8 weeks

  • Changes in blood parameters SOD

    SOD (superoxiddismutase) (ng/mL)

    8 weeks

  • Changes in blood parameters NFkB

    NFkB (nuclear factor kappa B) (% of change)

    8 weeks

  • Changes in blood parameters TNF alfa

    TNF alfa (tumor necrosis factor alpha) (% of change)

    8 weeks

  • Changes in blood parameters HSP 60

    HSP 60 (heat shock protein 60) (% of change)

    8 weeks

  • Changes in blood parameters HSP 70

    HSP 70 (heat shock protein 70) (% of change)

    8 weeks

  • Changes in blood parameters Alpha tocopherol

    Alpha tocopherol (μmol/L)

    8 weeks

  • Changes in blood parameters Gama tocopherol

    Gama tocopherol (μmol/L)

    8 weeks

  • Changes in blood parameters Beta carotene

    Beta carotene (μmol/L)

    8 weeks

  • Changes in blood parameters Coenzyme Q 10 in platelets

    Coenzyme Q 10 in platelets (pmol/10\^9 cells)

    8 weeks

  • Changes in blood parameters Coenzyme Q 10 in plasma

    Coenzyme Q 10 in plasma (μmol/L)

    8 weeks

  • Changes in blood parameters Coenzyme Q 10 in whole blood

    Coenzyme Q 10 in whole blood (μmol/L)

    8 weeks

Other Outcomes (7)

  • Entry check of patients health status- clinical examination SPG and SPL

    2 hours

  • Entry check of patients health status- urinary sediment

    2 hours

  • Entry check of patients health status- USG

    2 hours

  • +4 more other outcomes

Study Arms (2)

patients with NAFLD

ACTIVE COMPARATOR

17 patients will receive molecular hydrogen

Dietary Supplement: HRW drink, HRW Natural Health Products Inc., Made in Vancouver, Canada

probands in the control group

PLACEBO COMPARATOR

13 probands in the control group who will receive placebo.

Dietary Supplement: placebo

Interventions

HRW drink, HRW Natural Health Products Inc., Made in Vancouver, CanadaDIETARY_SUPPLEMENT

The cohort will consist of 17 patients with NAFLD. Name of the product that will be the source of molecular hydrogen: HRW drink, HRW Natural Health Products Inc., Made in Vancouver, Canada. It is a nutritional supplement that is a source of molecular hydrogen. All study participants will drink one tablet dissolved in 0.33 l of tap water every 8 hours. They did this for 8 weeks. Blood analysis at study entry and after 8 weeks (end of study).

patients with NAFLD
placeboDIETARY_SUPPLEMENT

13 probands in the control group who will receive placebo. All study participants will drink one placebo tablet dissolved in 0.33 l of tap water every 8 hours. They did this for 8 weeks. Blood analysis at study entry and after 8 weeks (end of study)

probands in the control group

Eligibility Criteria

Age33 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People with age 33-69 years
  • BMI ≥ 25
  • Confirmation of fatty liver by ultrasonographic examination
  • Signed informed consent
  • Alcohol intake according to the AUDIT questionnaire 5 or less points for men or 4 or less points for women

You may not qualify if:

  • Unsigned informed consent
  • BMI \< 25
  • Presence of severe inflammatory disease with activity (Crohn's disease, ulcerative colitis, active tuberculosis, rheumatoid arthritis, etc.)
  • Presence of acute infectious disease (acute hepatitis, peritonitis, cholecystitis, pancreatitis, etc.)
  • Presence of active neoplastic disease
  • Alcohol intake according to the AUDIT questionnaire more as 5 points for men or more as 4 points for women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

3rd Department of Internal Medicine Faculty of Medicine Comenius University in Bratislava

Bratislava, 83101, Slovakia

Location

Related Publications (5)

  • Gvozdjakova A, Klauco F, Kucharska J, Sumbalova Z. Is mitochondrial bioenergetics and coenzyme Q10 the target of a virus causing COVID-19? Bratisl Lek Listy. 2020;121(11):775-778. doi: 10.4149/BLL_2020_126.

    PMID: 33164536BACKGROUND

  • Gvozdjakova A, Sumbalova Z, Kucharska J, Komlosi M, Rausova Z, Vancova O, Szamosova M, Mojto V. Platelet Mitochondrial Respiration, Endogenous Coenzyme Q10 and Oxidative Stress in Patients with Chronic Kidney Disease. Diagnostics (Basel). 2020 Mar 23;10(3):176. doi: 10.3390/diagnostics10030176.

    PMID: 32210203BACKGROUND

  • Gvozdjakova A, Kucharska J, Sumbalova Z, Rausova Z, Chladekova A, Komlosi M, Szamosova M, Mojto V. The importance of coenzyme Q10 and its ratio to cholesterol in the progress of chronic kidney diseases linked to non- -communicable diseases. Bratisl Lek Listy. 2020;121(10):693-699. doi: 10.4149/BLL_2020_113.

    PMID: 32955899BACKGROUND

  • Gvozdjakova A, Kucharska J, Sumbalova Z, Nemec M, Chladekova A, Vancova O, Rausova Z, Kubalova M, Kuzmiakova Z, Mojto V. Platelets mitochondrial function depends on CoQ10 concentration in winter, not in spring season. Gen Physiol Biophys. 2019 Jul;38(4):325-334. doi: 10.4149/gpb_2019012. Epub 2019 Jun 26.

    PMID: 31241044BACKGROUND

  • Gvozdjakova A, Sumbalova Z, Kucharska J, Chladekova A, Rausova Z, Vancova O, Komlosi M, Ulicna O, Mojto V. Platelet mitochondrial bioenergetic analysis in patients with nephropathies and non-communicable diseases: a new method. Bratisl Lek Listy. 2019;120(9):630-635. doi: 10.4149/BLL_2019_104.

    PMID: 31475544BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2021

First Posted

April 13, 2022

Study Start

May 1, 2020

Primary Completion

December 1, 2020

Study Completion

December 18, 2020

Last Updated

April 13, 2022

Record last verified: 2022-04

Locations

SL(1)