Hydrogen-rich Water for Non-alchoholic Fatty Liver Disease

NCT03625362 | Completed

• 1 other identifier: 0417-HRW/2018
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates how 4-week supplementation with hydrogen-rich water affects liver fat accumulation, blood lipid profiles and body composition in patients with non-alcoholic fatty liver disease

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Liver fat content

  MRS spectra for liver triglycerides

  Change from baseline liver triglycerides at 4 weeks

Secondary Outcomes (2)

• Total cholesterol

  Change from baseline total cholesterol at 4 weeks

• Total body fatness

  Change from baseline fat percentage at 4 weeks

Study Arms (2)

Hydrogen

EXPERIMENTAL

1 L of hydrogen-rich water

Dietary Supplement: Hydrogen

Placebo

PLACEBO COMPARATOR

1 L of tap water

Dietary Supplement: Placebo

Interventions

Hydrogen DIETARY_SUPPLEMENT

Hydrogen-rich water

Hydrogen

Placebo DIETARY_SUPPLEMENT

Tap water

Placebo

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 years
• Body mass index \> 25 kg/m2
• Free of major diseases besides NAFLD
• Must be able to give written informed consent

You may not qualify if:

• Use of any dietary supplements within 4 weeks before study commences
• Abnormal values for lab clinical chemistry (\> 2 SD)

Sponsors & Collaborators

• University of Novi Sad, Faculty of Sport and Physical Education: lead

Study Sites (2)

Applied Bioenergetics Lab at Faculty of Sport and PE

Novi Sad, Vojvodina, 21000, Serbia

Location

FSPE Applied Bioenergetics Lab

Novi Sad, Vojvodina, 21000, Serbia

Location

Related Publications (4)

• Kajiyama S, Hasegawa G, Asano M, Hosoda H, Fukui M, Nakamura N, Kitawaki J, Imai S, Nakano K, Ohta M, Adachi T, Obayashi H, Yoshikawa T. Supplementation of hydrogen-rich water improves lipid and glucose metabolism in patients with type 2 diabetes or impaired glucose tolerance. Nutr Res. 2008 Mar;28(3):137-43. doi: 10.1016/j.nutres.2008.01.008.

  PMID: 19083400 BACKGROUND

• Nakao A, Toyoda Y, Sharma P, Evans M, Guthrie N. Effectiveness of hydrogen rich water on antioxidant status of subjects with potential metabolic syndrome-an open label pilot study. J Clin Biochem Nutr. 2010 Mar;46(2):140-9. doi: 10.3164/jcbn.09-100. Epub 2010 Feb 24.

  PMID: 20216947 BACKGROUND

• Korovljev D, Trivic T, Drid P, Ostojic SM. Molecular hydrogen affects body composition, metabolic profiles, and mitochondrial function in middle-aged overweight women. Ir J Med Sci. 2018 Feb;187(1):85-89. doi: 10.1007/s11845-017-1638-4. Epub 2017 May 30.

  PMID: 28560519 BACKGROUND

• Korovljev D, Stajer V, Ostojic J, LeBaron TW, Ostojic SM. Hydrogen-rich water reduces liver fat accumulation and improves liver enzyme profiles in patients with non-alcoholic fatty liver disease: a randomized controlled pilot trial. Clin Res Hepatol Gastroenterol. 2019 Nov;43(6):688-693. doi: 10.1016/j.clinre.2019.03.008. Epub 2019 Apr 11.

  PMID: 30982748 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Hydrogen

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Elements; Inorganic Chemicals; Gases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 10, 2018
• Study Start: September 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

SE (2)