An 8-week, randomized, double-blinded, placebo-controlled clinical trial to evaluate the efficacy and safety of Lactobacillus plantarum HAC01 on the postprandial glucose levels.
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0005652
- Lead Sponsor
- AtoGen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
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 < 90 mg/dl or = 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
6) Administration of antibiotic within 2 weeks before screening visit
7) Intake of probiotics or fermented milk products (yogurt, cheese, etc.) within 2 weeks before screening visit
8) Administration of corticosteroids within 4 weeks before screening visit
9) 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
10) Major medical illness such as cardiovascular, neurologic, hepatic, musculoskeletal system, psychiatric, endocrine system, immune, renal, malignant tumor and pulmonary disease etc.
11) History of alcohol or substance abuse
12) History of disease that can interfere with the test products or impede their absorption such as gastrointestinal disease or gastrointestinal surgery
13) Allergic or hypersensitivity to drug and any of the ingredients in the test products (probiotics)
14) Participation in other clinical trials within 3 months
15) AST or ALT > 3 fold of normal range or serum creatinine > 2.0 mg/dl
16) Female subjects of childbearing potential who are not willing to use appropriate contraception (except for surgery for female infertility)
17) Pregnant, planning to become pregnant, or breast-feeding
18) 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
- Secondary Outcome Measures
Name Time Method Fasting plasma glucose;Postprandial plasma glucose (30, 60, and 90 min);Fasting insulin;HOMA-IR, QUICKI;Lipid profile (total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol);Adiponectin;Leptine;Short chain fatty acid;Gut microbiome