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

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

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

Study Overview

• Status: Completed
• Conditions: PreDiabetes
• Intervention / Treatment: Other: Deep sea water; Other: Placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DSW (deep sea water) group; DSW, 440 ml/day for 8 weeks	Other: Deep sea water; Deep sea water 440 ml/day for 8 weeks
Placebo Comparator: Placebo group; Placebo, 440 ml/day for 8 weeks	Other: Placebo; Placeob water 440 ml/day for 8 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital
• Collaborators: Kyungpook National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2016
• Primary Completion (Actual): April 24, 2017
• Study Completion (Actual): August 28, 2017

Study Registration Dates

• First Submitted: May 17, 2019
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (Actual): May 21, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: CTCF2_2016_DSW

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No