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| Name | Class |
|---|---|
| Kyungpook National University Hospital | OTHER |
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This study was conducted to investigate the effects of daily supplementation of deep sea water on improvement of hyperglycemia
This study was a 8 weeks, randomized, double-blind, placebo-controlled, cross-over clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DSW (deep sea water) group | Experimental | DSW, 440 ml/day for 8 weeks |
|
| Placebo group | Placebo Comparator | Placebo, 440 ml/day for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Placeob water 440 ml/day for 8 weeks |
| |
| Deep sea water |
| 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 |
| 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 |
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Inclusion Criteria:
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
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
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Other |
Deep sea water 440 ml/day for 8 weeks |
|
| 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 |
| D004700 | Endocrine System Diseases |