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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03920436
Other study ID # 02-2018-035
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2019
Est. completion date July 31, 2019

Study information

Verified date September 2019
Source Pusan National University Yangsan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of oral ingestion of drinking water using a tumbler that emits far infrared rays at room temperature on metabolic profile in adults for 8 weeks.


Description:

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of oral ingestion of drinking water using a tumbler that emits far infrared rays at room temperature on metabolic profile in adults for 8 weeks; the safety of the compound are also evaluate. The Investigators examine lipid profile, glucose, liver and renal function at baseline, as well as after 4, 8 weeks of intervention. Thirty adults were administered either 1.8 L of drinking water using a tumbler that emits far infrared rays at room temperature or drinking water using a sham-tumbler each day for 12 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 31, 2019
Est. primary completion date July 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

- 19 years and older

Exclusion Criteria:

- aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than twice the highest reference value

- serum creatinine = 1.5 mg/dL)

- uncontrolled diabetes mellitus (a fasting glucose of >160 mg/dL)

- uncontrolled hypertension (BP > 160/100 mmHg)

- severe gastrointestinal symptoms

- alcohol abuser

- pregnant or lactating women

- allergic to the ingredient involved

- cardiocebrovascular diseases or any cancer during the six months prior to study

- smoker

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
infrared water group
This group takes 1,8 L of drinking water using a tumbler that emits far infrared rays at room temperature.
sham group
This group takes 1,8 L of drinking water using a tumbler at room temperature.

Locations

Country Name City State
Korea, Republic of Pusan National University Yangsan Hospital Yangsan Gyeungsangnam-do

Sponsors (1)

Lead Sponsor Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Low density lipoprotein cholesterol (LDL-C) Change of LDL-C during 8 weeks Change from baseline level of LDL-C at 8 weeks
Secondary aspartate transaminase (AST) Change of AST during 8 weeks Change from baseline level of AST at 8 weeks
Secondary creatinine Change of creatinine during 8 weeks Change from baseline level of creatinine at 8 weeks
Secondary homeostasis model assessment of insulin resistance (HOMA-IR) Change of HOMA-IR during 8 weeks Change from baseline level of HOMA-IR at 8 weeks
Secondary body weight Change of body weight during 8 weeks Change from baseline level at 8 weeks
Secondary free fatty acid Change of free fatty acid during 8 weeks Change from baseline level at 8 weeks
Secondary alanine transaminase (ALT) Change of ALT during 8 weeks Change from baseline level of ALT at 8 weeks
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