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

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Problems
• Intervention / Treatment: Dietary supplement: infrared water group; Dietary supplement: sham group

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
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeungsangnam-do
    • Yangsan, Gyeungsangnam-do, Korea, Republic of, 50612
      • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low density lipoprotein cholesterol (LDL-C)	Change of LDL-C during 8 weeks	Change from baseline level of LDL-C at 8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 02-2018-035

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No