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

Primary Purpose

PreDiabetes

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Placebo
Deep sea water
Sponsored by
Chonbuk National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PreDiabetes

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    DSW (deep sea water) group

    Placebo group

    Arm Description

    DSW, 440 ml/day for 8 weeks

    Placebo, 440 ml/day for 8 weeks

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    May 17, 2019
    Last Updated
    January 13, 2020
    Sponsor
    Chonbuk National University Hospital
    Collaborators
    Kyungpook National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03956914
    Brief Title
    Efficacy and Safety of Deep Sea Water on the Blood Glucose Level
    Official 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2, 2016 (Actual)
    Primary Completion Date
    April 24, 2017 (Actual)
    Study Completion Date
    August 28, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chonbuk National University Hospital
    Collaborators
    Kyungpook National University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    PreDiabetes

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DSW (deep sea water) group
    Arm Type
    Experimental
    Arm Description
    DSW, 440 ml/day for 8 weeks
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo, 440 ml/day for 8 weeks
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Placeob water 440 ml/day for 8 weeks
    Intervention Type
    Other
    Intervention Name(s)
    Deep sea water
    Intervention Description
    Deep sea water 440 ml/day for 8 weeks
    Primary Outcome Measure Information:
    Title
    Changes of blood glucose
    Description
    Concentration of fasting and postprandial glucose during OGTT (oral glucose tolerance test) were assessed before and after the intervention
    Time Frame
    Baseline, 8 weeks
    Secondary Outcome Measure Information:
    Title
    Changes of blood insulin
    Description
    Concentration of blood insulin were assessed before and after the intervention
    Time Frame
    Baseline, 8 weeks
    Title
    C-pepetide
    Description
    Concentration of C-peptide were assessed before and after the intervention
    Time Frame
    Baseline, 8 weeks
    Title
    HbA1c
    Description
    Concentration of HbA1c were assessed before and after the intervention
    Time Frame
    Baseline, 8 weeks
    Title
    Homeostatic model assessment - insulin resistance (HOMA-IR)
    Description
    Concentration of HOMA-IR were assessed before and after the intervention
    Time Frame
    Baseline, 8 weeks
    Title
    Total cholesterol
    Description
    Concentration of total cholesterol were assessed before and after the intervention
    Time Frame
    Baseline, 8 weeks
    Title
    Triglyceride
    Description
    Concentration of triglyceride were assessed before and after the intervention
    Time Frame
    Baseline, 8 weeks
    Title
    HDL-cholesterol
    Description
    Concentration of HDL-cholesterol were assessed befor and after the intervention
    Time Frame
    Baseline, 8 weeks
    Title
    LDL-cholesterol
    Description
    Concentration of LDL-cholesterol were assessed befor and after the intervention
    Time Frame
    Baseline, 8 weeks
    Title
    Weight
    Description
    Concentration of weight were assessed befor and after the intervention
    Time Frame
    Baseline, 8 weeks
    Title
    BMI
    Description
    Concentration of BMI were assessed before and after the invervention
    Time Frame
    Baseline, 8 weeks
    Title
    Body fat mass
    Description
    Concentration of body fat mass were assessed before and after the intervention
    Time Frame
    Baseline, 8 weeks
    Title
    Percent of body fat mass
    Description
    Concentration of percent of body fass mass were assessed before and after the intervention
    Time Frame
    Baseline, 8 weeks
    Title
    Waist circumference
    Description
    Concentration of waist circumference were assessed before and after the intervention
    Time Frame
    Baseline, 8 weeks
    Title
    Waist-hip ratio (WHR)
    Description
    Concentration of WHR were assessed before and after the intervention
    Time Frame
    Baseline, 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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