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

PreDiabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03956914
• Other study ID #: CTCF2_2016_DSW
• Status: Completed
• Phase: N/A
• Start date: June 2, 2016
• Est. completion date: August 28, 2017

Study information

• Verified date: January 2020
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 28, 2017
• Est. primary completion date: April 24, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• PreDiabetes
• Prediabetic State

Intervention

Other:
• Placebo
Placeob water 440 ml/day for 8 weeks
• Deep sea water
Deep sea water 440 ml/day for 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Chonbuk National University Hospital	Kyungpook National University Hospital

Outcome

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