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

Chonbuk National University

Status

Completed

Conditions

PreDiabetes

Treatments

Other: Placebo

Other: Deep sea water

Study type

Interventional

Funder types

Other

Identifiers

CTCF2_2016_DSW

Details and patient eligibility

About

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

Full description

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

Enrollment

40 patients

Sex

All

Ages

19 to 70 years old

Volunteers

Accepts 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