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

Not Applicable

Completed

• Conditions: PreDiabetes
• Interventions: Other: Deep sea water; Other: Placebo

• Registration Number: NCT03956914
• Lead Sponsor: Chonbuk National University Hospital

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2016-06-02
• Primary Completion: 2017-04-24
• Study Completion: 2017-08-28
• Study First Submitted: 2019-05-17
• Study First Submitted QC: 2019-05-17
• Study First Posted: 2019-05-21
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-13
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
DSW (deep sea water) group	Deep sea water	DSW, 440 ml/day for 8 weeks
Placebo group	Placebo	Placebo, 440 ml/day for 8 weeks

Primary Outcome Measures

Name	Time	Method
Changes of blood glucose	Baseline, 8 weeks	Concentration of fasting and postprandial glucose during OGTT (oral glucose tolerance test) were assessed before and after the intervention

Secondary Outcome Measures

Name	Time	Method
Homeostatic model assessment - insulin resistance (HOMA-IR)	Baseline, 8 weeks	Concentration of HOMA-IR were assessed before and after the intervention
Changes of blood insulin	Baseline, 8 weeks	Concentration of blood insulin were assessed before and after the intervention
C-pepetide	Baseline, 8 weeks	Concentration of C-peptide were assessed before and after the intervention
LDL-cholesterol	Baseline, 8 weeks	Concentration of LDL-cholesterol were assessed befor and after the intervention
Weight	Baseline, 8 weeks	Concentration of weight were assessed befor and after the intervention
Waist circumference	Baseline, 8 weeks	Concentration of waist circumference were assessed before and after the intervention
HbA1c	Baseline, 8 weeks	Concentration of HbA1c were assessed before and after the intervention
Triglyceride	Baseline, 8 weeks	Concentration of triglyceride were assessed before and after the intervention
HDL-cholesterol	Baseline, 8 weeks	Concentration of HDL-cholesterol were assessed befor and after the intervention
BMI	Baseline, 8 weeks	Concentration of BMI were assessed before and after the invervention
Body fat mass	Baseline, 8 weeks	Concentration of body fat mass were assessed before and after the intervention
Percent of body fat mass	Baseline, 8 weeks	Concentration of percent of body fass mass were assessed before and after the intervention
Total cholesterol	Baseline, 8 weeks	Concentration of total cholesterol were assessed before and after the intervention
Waist-hip ratio (WHR)	Baseline, 8 weeks	Concentration of WHR were assessed before and after the intervention