Effects of Oral Ingestion of Drinking Water Using a Tumbler That Emits Far Infrared Rays on Metabolic Profile
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 16, 2019
CompletedFirst Posted
Study publicly available on registry
April 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2019
CompletedSeptember 11, 2019
September 1, 2019
5 months
April 16, 2019
September 10, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Low density lipoprotein cholesterol (LDL-C)
Change of LDL-C during 8 weeks
Change from baseline level of LDL-C at 8 weeks
Secondary Outcomes (6)
aspartate transaminase (AST)
Change from baseline level of AST at 8 weeks
creatinine
Change from baseline level of creatinine at 8 weeks
homeostasis model assessment of insulin resistance (HOMA-IR)
Change from baseline level of HOMA-IR at 8 weeks
body weight
Change from baseline level at 8 weeks
free fatty acid
Change from baseline level at 8 weeks
- +1 more secondary outcomes
Study Arms (2)
Infrared water group
EXPERIMENTALThis group takes drinking water using a tumbler that emits far infrared rays at room temperature for 8 weeks.
sham group
SHAM COMPARATORThis group takes drinking water using a tumbler at room temperature for 8 weeks.
Interventions
This group takes 1,8 L of drinking water using a tumbler that emits far infrared rays at room temperature.
This group takes 1,8 L of drinking water using a tumbler at room temperature.
Eligibility Criteria
You may qualify if:
- years and older
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, 50612, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Sang Yeoup Lee
Pusan National University Yangsan Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Family Medicine
Study Record Dates
First Submitted
April 16, 2019
First Posted
April 18, 2019
Study Start
February 1, 2019
Primary Completion
July 1, 2019
Study Completion
July 31, 2019
Last Updated
September 11, 2019
Record last verified: 2019-09