Effects of Hydrogen Rich Water on Risk Factors of Heart Disease and Diabetes.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2018/03/012487
• Date of registration: 12-03-2018
• Prospective Registration: Yes
• Primary sponsor: Natural Wellness Now Health Products Inc
• Public title: Effects of Hydrogen Rich Water on Risk Factors of Heart Disease and Diabetes.
• Scientific title: Effects of Hydronen Magnesium Tablets on Cardiometabolic Risk Factors and Inflammation in Subjects with Metabolic Syndrome.
• Date of first enrolment: 01-05-2018
• Target sample size: 120
• Recruitment status: Not Yet Recruiting
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=23330
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Participant, Investigator and Outcome Assessor Blinded
• Phase: Phase 2

Countries of recruitment

India, Slovakia

Contacts

• Name: Dr R B Singh
• Affiliation: Halberg Hospital and research Institute

• Name: Dr R B Singh
• Affiliation: Halberg Hospital and research Institute

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria: Adults aged 30-60 years without recent AMI or stroke, with any of the three markers of metabolic syndrome; prehypertension, prediabetes and central obesity or dyslipidemia.

Criteria of diagnosis. Prehypertension would be considered in presence of systolic BP 130-139 mm HG and diastolic 85-89 mm Hg. Pre-diabetes would be considered in presence of fasting blood glucose 110-125 mg/dl. Central obesity would be considered in presence of waste circumference of 100 mm in women and 90 mm among men.


Exclusion criteria: Exclusion criteria: cancer, chronic dysentery, HIV

Age minimum:
Age maximum:
Gender:

Intervention(s)

Intervention1: Hydrogen-manesium tablets: Active ingredient: Hydrogen-Rich Water (HRW). HRW is made with a H2-producing tablet that contains non-ionic metallic magnesium with organic acids (malic and tartaric). IT also contains small amount of dextrose (200 mg), and the lubricant PRUV (Sodium Stearyl Fumarate), which is a commonly used lubricating agent for tablets and other products. There are no indications that it is toxic, and it is approved as GRAS by the FDA. The active magnesium reacts with water to produce molecular hydrogen (H2) and magnesium hydroxide [Mg(OH)2] according to the reaction: Mg + 2H2O -- H2 + Mg(OH)2. The magnesium hydroxide is then neutralized by the organic acids leaving magnesium ions and their conjugate bases (Mg(OH)2 + malic acid/tartaric acid -- Mg2+ + malate + tartrate). The amount of Mg in each tablet is 80mg, which is well below the daily reference intake (DRI), and upper limit, thus avoiding any adverse events from magnesium ingestion. (https://ods.od.nih.gov/factsheets/Magnesium-HealthProfessional/).and inactive placebo tabs.
Control Intervention1: Placebo tablets: Identical placebo tablets with inactive agent

Primary Outcome(s)

Primary: Effects of h2 magnesium tablets on various markers of metabolic syndrome; blood pressures, blood glucose and central obesity,triglycerides and HDL cholesterol as well as hsCRP along with parameters of oxidative stress; TBARS,MDA, diene conjugatesTimepoint: Baseline

After 4 weeks

After 12 weeks

After 24 weeks

Secondary Outcome(s)

Secondary: effects on IL-6,IL-1,TNF-alpha,IL-10, NFkbeta, MMPs,leptin, cortisolTimepoint: Baseline and after 12 or 24 weeks,if funds available

Secondary ID(s)

NIL

Source(s) of Monetary Support

President, Natural Wellness Now Health Products Inc. #106 555 Foster Ave, Coquitlam BC, V3J 0B6 Canada. Email [e-mail]

Secondary Sponsor(s)

International College of Nutrition

Ethics review

Status: Approved
Approval date: 07/03/2018
Contact:

Halberg Hospital and Research Institute Ethic Committee