A human study for evaluating effectiveness and safety of GF bacillus enzyme SOD on antioxidant capacity
- Conditions
- Factors influencing health status and contact with health servisces
- Registration Number
- KCT0003081
- Lead Sponsor
- Ewha Womans University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
1) Subject who voluntarily agree to participate and signs informed consent form
2) Age more than 30 year old and less than 65 years old (Ratio of men and women 1:1)
3) Less than 36 of Recommended Foods Score
4) Subject who comply more than one thing of the following categories
-150mg/dL =Blood triglycerides< 200 mg/dL
-200mg/dL =Blood total cholesterol< 240 mg/dL
-130mg/dL =Blood LDL-cholesterol< 160 mg/d
1) Impossible to performa treadmill activity
2) Continuous intensive workout (more than 7 hours a week) within 3 months from the first visit
3) Chronic smoker (= 10 cigarettes / day)
4) Intake more than 420 g of pure alcohol a week (Soju 7bottles/week, 1bottle/day) or an alcoholic
5) BMI<23 or BMI=30
6) Controlling body weight or have changed of body weight more than 4kg within 4 weeks before the first visit
7) Having difficult to consist the current workout habits or diet habits during the study
8) Comply the following categories
- Treated with hormone treatment within 6 months before the first visit
- Have following diseases or taking relevant medicines: thromboembolism, inflammatory disease, liver disease, kidney disease, cerebrovascular disease, cancer, uterine disease, Cardiovascular disease( hypertension, stroke etc), thyroid disease, interstinal disease, diabetes or hyperlipidemia with drug treatment
- A mental patient
- Therapeutic uses of coumadin, aspirin, or other medications that influence hemostasis within four weeks of the Screening visit. Preventive use of low-dose aspirin (e.g. 100-mg a day) is allowed.
9) Continuous consumption of health functional food(rasberry wine, Pycnogenol, Coenzyme Q10, meron extract, antioxidantsmultivitamin etc), prebiotics (dietary fiber, oligosaccharide etc) and probiotics (lactobacillus) within 1 months before the first visit
10) Donated blood within 1 month before the first visit
11) Known hypersensitivity to study product or any ingredient in study product
12) Planning to be pregnant, Pregnant or lactating women
13) Participation in other human study within 1 month before the first visit
14) Subject who has difficult to handle smartphone
15) Any condition that the principal investigator believes may put the subjects at under risk
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method antioxidant enzyme activity (Superoxide dismutase, glutathione peroxidase, catalase activity);glutathione
- Secondary Outcome Measures
Name Time Method malondialdehyde