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Completed

NCT Number: NCT03956914

Efficacy and Safety of Deep Sea Water on the Blood Glucose Level

This study was conducted to investigate the effects of daily supplementation of deep sea water on improvement of hyperglycemia

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This study was a 8 weeks, randomized, double-blind, placebo-controlled, cross-over clinical trial.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Fasting plasma glucose concentration of 100-140 mg/dL or 2h-postprandial plasma glucose concentration of 140 ~199 mg/dL

Exclusion criteria

  • Patients with type 1 or type 2 diabetes
  • HbA1c ≥9.0%
  • Weight decreased by more than 10% within past 3 months
  • Have clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, hepatic biliary system, kidney and Urinary system, neuropsychiatry, musculoskeletal, inflammatory and hematologic malignancies, gastrointestinal disorders, etc.
  • Hypoglycemic agent, obesity medicine, lipid lowering agent within past 6 months or functional food within past 2 month
  • Subjects who have taken corticosteroid within past 1 months
  • History of alcohol or substance abuse
  • Participation in any other clinical trials within past 2 months
  • Laboratory test by show the following results
  • Serum AST (aspartate aminotransferase) or ALT (alanine aminotransferase) > 2 times the upper limit of normal range
  • Serum Creatinine > 2.0 mg/dl
  • Pregnancy or breast feeding
  • If a woman of childbearing doesn't accept the implementation of appropriate contraception
  • Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc

Treatment and study plan

Placebo

Other

Placeob water 440 ml/day for 8 weeks

Deep sea water

Other

Deep sea water 440 ml/day for 8 weeks

Primary outcomes

  1. Changes of blood glucose

    Time frame: Baseline, 8 weeks

    Concentration of fasting and postprandial glucose during OGTT (oral glucose tolerance test) were assessed before and after the intervention

Secondary outcomes

  1. Changes of blood insulin

    Time frame: Baseline, 8 weeks

    Concentration of blood insulin were assessed before and after the intervention

  2. C-pepetide

    Time frame: Baseline, 8 weeks

    Concentration of C-peptide were assessed before and after the intervention

  3. HbA1c

    Time frame: Baseline, 8 weeks

    Concentration of HbA1c were assessed before and after the intervention

  4. Homeostatic model assessment - insulin resistance (HOMA-IR)

    Time frame: Baseline, 8 weeks

    Concentration of HOMA-IR were assessed before and after the intervention

  5. Total cholesterol

    Time frame: Baseline, 8 weeks

    Concentration of total cholesterol were assessed before and after the intervention

  6. Triglyceride

    Time frame: Baseline, 8 weeks

    Concentration of triglyceride were assessed before and after the intervention

  7. HDL-cholesterol

    Time frame: Baseline, 8 weeks

    Concentration of HDL-cholesterol were assessed befor and after the intervention

  8. LDL-cholesterol

    Time frame: Baseline, 8 weeks

    Concentration of LDL-cholesterol were assessed befor and after the intervention

  9. Weight

    Time frame: Baseline, 8 weeks

    Concentration of weight were assessed befor and after the intervention

  10. BMI

    Time frame: Baseline, 8 weeks

    Concentration of BMI were assessed before and after the invervention

  11. Body fat mass

    Time frame: Baseline, 8 weeks

    Concentration of body fat mass were assessed before and after the intervention

  12. Percent of body fat mass

    Time frame: Baseline, 8 weeks

    Concentration of percent of body fass mass were assessed before and after the intervention

  13. Waist circumference

    Time frame: Baseline, 8 weeks

    Concentration of waist circumference were assessed before and after the intervention

  14. Waist-hip ratio (WHR)

    Time frame: Baseline, 8 weeks

    Concentration of WHR were assessed before and after the intervention

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Collaborators

  • Kyungpook National University Hospital

Registry information

Official study title

A 8-weeks, Randomized, Double-blind, Placebo-Controlled, Cross-Over Clinical Trials to Evaluated the Efficacy and Safety of Deep Sea Water on Blood Glucose Level

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 21, 2019
Registry last updated
Jan 18, 2020

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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