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

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

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

Official Title
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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

Conditions
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PreDiabetes

Intervention / Treatment
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* Other: Placebo
* Other: Deep sea water


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DSW (deep sea water) group<br>DSW, 440 ml/day for 8 weeks | Other: Deep sea water<br>* Deep sea water 440 ml/day for 8 weeks<br>|
| Placebo Comparator: Placebo group<br>Placebo, 440 ml/day for 8 weeks | Other: Placebo<br>* Placeob water 440 ml/day for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of blood glucose | Concentration of fasting and postprandial glucose during OGTT (oral glucose tolerance test) were assessed before and after the intervention | Baseline, 8 weeks | 

Secondary Outcome Measures

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