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Completed

NCT Number: NCT03920436

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

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.

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Key information

Conditions

Metabolic Problems

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, 50612, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

infrared water group

Dietary Supplement

This group takes 1,8 L of drinking water using a tumbler that emits far infrared rays at room temperature.

sham group

Dietary Supplement

This group takes 1,8 L of drinking water using a tumbler at room temperature.

Primary outcomes

  1. 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

Secondary outcomes

  1. aspartate transaminase (AST)

    Time frame: Change from baseline level of AST at 8 weeks

    Change of AST during 8 weeks

  2. creatinine

    Time frame: Change from baseline level of creatinine at 8 weeks

    Change of creatinine during 8 weeks

  3. 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

  4. body weight

    Time frame: Change from baseline level at 8 weeks

    Change of body weight during 8 weeks

  5. free fatty acid

    Time frame: Change from baseline level at 8 weeks

    Change of free fatty acid during 8 weeks

  6. alanine transaminase (ALT)

    Time frame: Change from baseline level of ALT at 8 weeks

    Change of ALT during 8 weeks

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 18, 2019
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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