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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

Tracking Information
First Submitted Date  ICMJE April 16, 2019
First Posted Date  ICMJE April 18, 2019
Last Update Posted Date September 11, 2019
Actual Study Start Date  ICMJE February 1, 2019
Actual Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
  • aspartate transaminase (AST) [ Time Frame: Change from baseline level of AST at 8 weeks ]
    Change of AST during 8 weeks
  • creatinine [ Time Frame: Change from baseline level of creatinine at 8 weeks ]
    Change of creatinine during 8 weeks
  • 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
  • body weight [ Time Frame: Change from baseline level at 8 weeks ]
    Change of body weight during 8 weeks
  • free fatty acid [ Time Frame: Change from baseline level at 8 weeks ]
    Change of free fatty acid during 8 weeks
  • alanine transaminase (ALT) [ Time Frame: Change from baseline level of ALT at 8 weeks ]
    Change of ALT during 8 weeks
Original Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
  • aspartate transaminase (AST), alanine transaminase (ALT) [ Time Frame: Change from baseline level of AST and ALT at 8 weeks ]
    Change of AST and ALT during 8 weeks
  • creatinine [ Time Frame: Change from baseline level of creatinine at 8 weeks ]
    Change of creatinine during 8 weeks
  • 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
  • body weight [ Time Frame: Change from baseline level at 8 weeks ]
    Change of body weight during 8 weeks
  • free fatty acid [ Time Frame: Change from baseline level at 8 weeks ]
    Change of free fatty acid during 8 weeks
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Oral Ingestion of Drinking Water Using a Tumbler That Emits Far Infrared Rays on Metabolic Profile
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Metabolic Problems
Intervention  ICMJE
  • 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.
  • Dietary Supplement: sham group
    This group takes 1,8 L of drinking water using a tumbler at room temperature.
Study Arms  ICMJE
  • Experimental: Infrared water group
    This group takes drinking water using a tumbler that emits far infrared rays at room temperature for 8 weeks.
    Intervention: Dietary Supplement: infrared water group
  • Sham Comparator: sham group
    This group takes drinking water using a tumbler at room temperature for 8 weeks.
    Intervention: Dietary Supplement: sham group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 31, 2019
Actual Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03920436
Other Study ID Numbers  ICMJE 02-2018-035
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sang Yeoup Lee, Pusan National University Yangsan Hospital
Study Sponsor  ICMJE Pusan National University Yangsan Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sang Yeoup Lee Pusan National University Yangsan Hospital
PRS Account Pusan National University Yangsan Hospital
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP