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

Not Applicable

Completed

• Conditions: Metabolic Problems
• Interventions: Dietary Supplement: sham group; Dietary Supplement: infrared water group

• Registration Number: NCT03920436
• Lead Sponsor: Pusan National University Yangsan Hospital

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 Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-04-16
• Study First Posted: 2019-04-18
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham group	sham group	This group takes drinking water using a tumbler at room temperature for 8 weeks.
Infrared water group	infrared water group	This group takes drinking water using a tumbler that emits far infrared rays at room temperature for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Low density lipoprotein cholesterol (LDL-C)	Change from baseline level of LDL-C at 8 weeks	Change of LDL-C during 8 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Gyeungsangnam-do, Korea, Republic of