UMIN-CTR Clinical Trial

Public title

Evaluation of electrolyzed hydrogen water to metabolic syndrome patients in Susaki city- Double blind clinical trial

Acronym

Evaluation of hydrogen rich water.

Scientific Title

Evaluation of electrolyzed hydrogen water to metabolic syndrome patients in Susaki city- Double blind clinical trial

Scientific Title:Acronym

Evaluation of hydrogen rich water.

Region

Japan

Condition

metabolic syndrome

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Oxidative stress is implicated in the pathogenesis of various disorders, from age-related cognitive decline and lifestyle-related diseases to cancers; and, in recent years, electrolyzed hydrogen water has been studied for its anti-oxidant properties in clinical trials. However, no human study yet has examined whether a long-term intake of EHW could improve metabolic syndrome. We evaluate the effects of a long-term intake of EHW on metabolic syndrome in Susaki city.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Primary outcomes

Changing abdominal Circumstance from baseline

Key secondary outcomes

1.Changes from baseline in stress markers Urinary 8-OHdG, urinary 8-isoprastane, urinary nitrotyrosine 2.Changes from baseline in metabolic syndrome evaluation items Fasting blood sugar, HbA1C, T-C, TG, HDL-C, blood pressure, weight 3.Comparison of nutritional calculation results from FFQ (Food Intake Survey) 4.Effect of test water consumption and hydrogen concentration on evaluation items 5.Presence or absence of adverse events (type, severity, safety level, frequency of occurrence) and frequency of expression)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Drink EH water daily 350 mL 3 times per day for 3 months.

Interventions/Control_2

Drink Placebo water daily 350 mL 3 times per day for 3 months.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

30

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Persons who are 30 years of age or older who have a resident card and residence in Susaki City and who can install a hydrogen water conditioner (test water conditioner)
2.One who was diagnosed as either 1) or 2)
1) Metabolic syndrome group (from the examination meeting of the Ministry of Health, Labor and Welfare Study meeting) Abdominal girth (male 85 cm or more, female 90 cm or more) plus two or more of the following items
A: sugar metabolism (fasting blood glucose 110 mg / dL or more)
b: Lipid (neutral fat 150 mg / dL or more or HDL-C 40 mg / dL or less)
C: Blood pressure (at least 130 mmHg in systole and / or at least 85 mmHg in diastole)
If you are receiving medication for high TG, low HDL-C, hypertension, diabetes, each item
To
2) Metabolic Syndrome Preliminary Group (From the results of the study meeting of the Ministry of Health, Labor and Welfare)
D: Abdominal girth (male 85 cm or more, female 90 cm or more) Persons whose sugar metabolism, lipid, blood pressure abnormality is up to one item
E: Abdominal circumference is not more than the reference value reference value, but those who have BMI 25 or more and have one or more of the above risks
Include in each item if you are receiving medication for high TG, low HDL-C, high blood pressure, diabetes.

Key exclusion criteria

1.Person who has judged that doctor is ineligible for participation 1) Heart disease Persons with chronic kidney disease 2) A person with a disease accompanied by weight loss (thyroid hyperthyroidism etc.) 3) There are severe diseases or malignant tumors etc. Person who installed a hydrogen water server 3 Person who is not gaining consent Rationale For setting 1, consideration is given to the safety of the research subjects For. 3) Malignant tumor: When five years have elapsed after completion of recovery, it can be incorporated. 2 In order to influence the main evaluation items.

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Narufumi Suganuma

Organization

Kochi University

Division name

Department of Preventive Medicine

Zip code

Address

Kohasu, Oko, Nankoku, Kochi, Japan

TEL

088-880-2407

Email

nsuganuma@kochi-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Ryoji Hirota

Organization

Kochi University

Division name

Department of Preventive Medicine

Zip code

Address

Kohasu, Oko, Nankoku, Kochi, Japan

TEL

088-880-2407

Homepage URL

Email

ryoryo2003@yahoo.co.jp

Institute

Department of Preventive Medicine,Kochi University

Institute

Department

Personal name

Organization

Nihon Trim Co. Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

高陵病院（高知県須崎市）、須崎くろしお病院（高知県須崎市）

Date of disclosure of the study information

2017

Year

09

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2017

Year

11

Month

09

Day

Date of IRB

Anticipated trial start date

2017

Year

12

Month

04

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

09

Month

28

Day

Last modified on

2023

Year

12

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033514