COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Oral Ingestion of Drinking Water Using a Tumbler That Emits Far Infrared Rays on Metabolic Profile

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03920436
Recruitment Status : Completed
First Posted : April 18, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Sang Yeoup Lee, Pusan National University Yangsan Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Metabolic Problems Dietary Supplement: infrared water group Dietary Supplement: sham group Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Oral Ingestion of Drinking Water Using a Tumbler That Emits Far Infrared Rays at Room Temperature on Metabolic Profile in Adults: a RCT
Actual Study Start Date : February 1, 2019
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: Infrared water group
This group takes drinking water using a tumbler that emits far infrared rays at room temperature for 8 weeks.
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 Comparator: sham group
This group takes drinking water using a tumbler at room temperature for 8 weeks.
Dietary Supplement: sham group
This group takes 1,8 L of drinking water using a tumbler at room temperature.




Primary Outcome Measures :
  1. Low density lipoprotein cholesterol (LDL-C) [ Time Frame: Change from baseline level of LDL-C at 8 weeks ]
    Change of LDL-C during 8 weeks


Secondary Outcome Measures :
  1. aspartate transaminase (AST) [ Time Frame: Change from baseline level of AST at 8 weeks ]
    Change of AST during 8 weeks

  2. creatinine [ Time Frame: Change from baseline level of creatinine at 8 weeks ]
    Change of creatinine during 8 weeks

  3. homeostasis model assessment of insulin resistance (HOMA-IR) [ Time Frame: Change from baseline level of HOMA-IR at 8 weeks ]
    Change of HOMA-IR during 8 weeks

  4. body weight [ Time Frame: Change from baseline level at 8 weeks ]
    Change of body weight during 8 weeks

  5. free fatty acid [ Time Frame: Change from baseline level at 8 weeks ]
    Change of free fatty acid during 8 weeks

  6. alanine transaminase (ALT) [ Time Frame: Change from baseline level of ALT at 8 weeks ]
    Change of ALT during 8 weeks



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920436


Locations
Layout table for location information
Korea, Republic of
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, Korea, Republic of, 50612
Sponsors and Collaborators
Pusan National University Yangsan Hospital
Investigators
Layout table for investigator information
Principal Investigator: Sang Yeoup Lee Pusan National University Yangsan Hospital
Layout table for additonal information
Responsible Party: Sang Yeoup Lee, Professor of Family Medicine, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier: NCT03920436    
Other Study ID Numbers: 02-2018-035
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No