Metabolic ProblemsNCT03920436
Effects of Oral Ingestion of Drinking Water Using a Tumbler That Emits Far Infrared Rays on Metabolic Profile
A study testing infrared water group in people with Metabolic Problems, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Problems
- What is being tested?
- infrared water group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2019to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 19 years and older
Who cannot join
- 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
Show all 10Show fewer
- pregnant or lactating women
- allergic to the ingredient involved
- cardiocebrovascular diseases or any cancer during the six months prior to study
- smoker
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, 50612
About this study
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
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.
Read the 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.
- Conditions
- Metabolic Problems
- Being tested
- infrared water group, sham group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infrared water groupDietary supplement
This group takes 1,8 L of drinking water using a tumbler that emits far infrared rays at room temperature.
sham groupDietary supplement
This group takes 1,8 L of drinking water using a tumbler at room temperature.
| Study group | Role | What they receive |
|---|---|---|
| Infrared water group | Experimental | This group takes drinking water using a tumbler that emits far infrared rays at room temperature for 8 weeks. Receives: Dietary Supplement: infrared water group |
| sham group | Sham comparator | This group takes drinking water using a tumbler at room temperature for 8 weeks. Receives: Dietary Supplement: sham group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low density lipoprotein cholesterol (LDL-C)
Change of LDL-C during 8 weeks
Measured: Change from baseline level of LDL-C at 8 weeks
Secondary outcomes (6)
aspartate transaminase (AST)
Change of AST during 8 weeks
Measured: Change from baseline level of AST at 8 weeks
creatinine
Change of creatinine during 8 weeks
Measured: Change from baseline level of creatinine at 8 weeks
homeostasis model assessment of insulin resistance (HOMA-IR)
Change of HOMA-IR during 8 weeks
Measured: Change from baseline level of HOMA-IR at 8 weeks
body weight
Change of body weight during 8 weeks
Measured: Change from baseline level at 8 weeks
free fatty acid
Change of free fatty acid during 8 weeks
Measured: Change from baseline level at 8 weeks
alanine transaminase (ALT)
Change of ALT during 8 weeks
Measured: Change from baseline level of ALT at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start1 Feb 2019
- Primary completion1 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Yeoup Lee, Pusan National University Yangsan Hospital
- Investigators
- Sang Yeoup Lee, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920436
- Sponsor's protocol ID
- 02-2018-035
- Status last verified
- Sep 2019
- First submitted
- 16 Apr 2019
- Last updated
- 11 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03920436
- Acronym / sponsor ID
- 02-2018-035
- Conditions
- Metabolic Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 18 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infrared water group | Experimental | Dietary Supplement: infrared water groupThis group takes drinking water using a tumbler that emits far infrared rays at room temperature for 8 weeks. |
| sham group | Sham comparator | Dietary Supplement: sham groupThis group takes drinking water using a tumbler at room temperature for 8 weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 19 years and older
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| infrared water groupThis group takes 1,8 L of drinking water using a tumbler that emits far infrared rays at room temperature. | Dietary supplement | Infrared water group |
| sham groupThis group takes 1,8 L of drinking water using a tumbler at room temperature. | Dietary supplement | sham group |
Primary outcome
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
6 secondary outcomes
aspartate transaminase (AST)
Time frame: Change from baseline level of AST at 8 weeks
creatinine
Time frame: Change from baseline level of creatinine at 8 weeks
homeostasis model assessment of insulin resistance (HOMA-IR)
Time frame: Change from baseline level of HOMA-IR at 8 weeks
body weight
Time frame: Change from baseline level at 8 weeks
free fatty acid
Time frame: Change from baseline level at 8 weeks
alanine transaminase (ALT)
Time frame: Change from baseline level of ALT at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
Related trials for Metabolic Problems
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Use a Breathing Machine (PAP) (VESPER-OSA 1)
Apnea, Sleep Disorders
Recruiting
Effects of Medisinstart for Type 2 Diabetes
Type 2 Diabetes
Not yet recruitingPhase 3
A Study of Orforglipron (LY3502970) in Chinese Participants With Obesity or Overweight and Weight-Related Health Problems
Obesity, Overweight
Active, not recruiting
Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers
Dementia, Dementia, Vascular
Not yet recruitingPhase 2
Efficacy and Safety of Olatorepatide Versus Placebo in Adults With Moderate to Severe Hidradenitis Suppurativa Living With Overweight or Obesity
Hidradenitis Suppurativa
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang Yeoup Lee principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing infrared water group in people with Metabolic Problems, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low density lipoprotein cholesterol (LDL-C) (time frame: Change from baseline level of LDL-C at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.