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Clinical Trials/NCT03920436
NCT03920436
Completed
Not Applicable

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

Pusan National University Yangsan Hospital1 site in 1 country30 target enrollmentFebruary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metabolic Problems
Sponsor
Pusan National University Yangsan Hospital
Enrollment
30
Locations
1
Primary Endpoint
Low density lipoprotein cholesterol (LDL-C)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
July 31, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sang Yeoup Lee

Professor of Family Medicine

Pusan National University Yangsan Hospital

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • creatinine(Change from baseline level of creatinine at 8 weeks)
  • body weight(Change from baseline level at 8 weeks)
  • aspartate transaminase (AST)(Change from baseline level of AST at 8 weeks)
  • free fatty acid(Change from baseline level at 8 weeks)
  • homeostasis model assessment of insulin resistance (HOMA-IR)(Change from baseline level of HOMA-IR at 8 weeks)
  • alanine transaminase (ALT)(Change from baseline level of ALT at 8 weeks)

Study Sites (1)

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