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

• ClinicalTrials.gov Identifier: NCT03920436
• Recruitment Status: Completed
• First Posted: April 18, 2019
• Last Update Posted: September 11, 2019
• Sponsor: Pusan National University Yangsan Hospital
• Information provided by (Responsible Party): Sang Yeoup Lee, Pusan National University Yangsan Hospital

Tracking Information

• First Submitted Date: April 16, 2019
• First Posted Date: April 18, 2019
• Last Update Posted Date: September 11, 2019
• Actual Study Start Date: February 1, 2019
• Actual Primary Completion Date: July 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: Effects of Oral Ingestion of Drinking Water Using a Tumbler That Emits Far Infrared Rays on Metabolic Profile
• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Metabolic Problems

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.
• Dietary Supplement: sham group
  This group takes 1,8 L of drinking water using a tumbler at room temperature.

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 16, 2019): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 31, 2019
• Actual Primary Completion Date: July 1, 2019 (Final data collection date for primary outcome measure)

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
• smoker

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT03920436
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Sang Yeoup Lee, Pusan National University Yangsan Hospital
• Study Sponsor: Pusan National University Yangsan Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sang Yeoup Lee; Pusan National University Yangsan Hospital

• PRS Account: Pusan National University Yangsan Hospital
• Verification Date: September 2019