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

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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

Study Description
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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.
Study Design
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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

Arms and Interventions
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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.


Outcome Measures
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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


Eligibility Criteria
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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
Contacts and Locations
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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
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Korea, Republic of
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, Korea, Republic of, 50612
Sponsors and Collaborators
Pusan National University Yangsan Hospital
Investigators
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Principal Investigator: Sang Yeoup Lee Pusan National University Yangsan Hospital
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No