A 12-week, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of deep sea water mineral extracts on the blood glucose levels.
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0008695
- Lead Sponsor
- QBM Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
1) Aged 19 to 70 years
2) Isolated-impaired glucose tolerance (plasma glucose levels from 140 to 199 mg/dl two hours after a 75 g oral glucose consumption during an oral glucose tolerance test)
3) Voluntary agreement to participate in the clinical trials and provision of informed consent
1) Fasting plasma glucose level = 140 mg/dl
2) HbA1c=7.0%
3) History of underlying type 1 or type 2 diabetes mellitus
4) Reduction of 10% weight within 3 months
5) Systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg (Those who are stably controlling their blood pressure with medication can participate)
6) Administration of corticosteroids within 4 weeks before screening visit
7) Administration of hypoglycemic agents, anti-obesity drugs, lipid-lowering agents etc. within 3 months or intake of functional foods that affect blood glucose or obesity or lipid metabolism within 2 months before screening visit
8) Administration of mineral supplements within 3 months before screening visit
9) Major medical illness such as cardiovascular, neurologic, hepatic, musculoskeletal system, psychiatric, endocrine system, immune, renal, malignant tumor and pulmonary disease etc.
10) History of alcohol or substance abuse
11) History of disease that can interfere with the test products or impede their absorption such as gastrointestinal disease or gastrointestinal surgery
12) Allergic or hypersensitivity to drug and any of the ingredients in the test products (magnesium)
13) Participation in other clinical trials within 3 months
14) AST or ALT > 3 fold of normal range or serum creatinine > 2.0 mg/dl
15) Female subjects of childbearing potential who are not willing to use appropriate contraception
16) Pregnant, planning to become pregnant, or breast-feeding
17) Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2-hour postprandial plasma glucose;incremental area under the curve (iAUC)
- Secondary Outcome Measures
Name Time Method Fasting plasma glucose;Postprandial plasma glucose (30, 60, and 90 min);Insulin (0, 30, 60, and 90 min);HOMA-IR, QUICKI, ISI, HOMA-ß; C-peptide;Lipid profile (total cholesterol, triglyceride, HDL-cholesterol and LDL-cholesterol);hs-CRP ;Serum magnesium and calcium levels