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A human study for evaluating effectiveness and safety of Theracurmin CR-033P on antioxidant capacity

Not Applicable
Completed
Conditions
Not Applicable
Registration Number
KCT0003322
Lead Sponsor
Chungnam National University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
80
Inclusion Criteria

1) Subject who voluntarily agree to participate and signs informed consent form
2) Men and women aged 20 to under 65.
3) fulfill the current workout habits or diet habits during the study.

Exclusion Criteria

1) Impossible to performa treadmill activity
2) Continuous intensive workout (more than 1.5 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) Recommended Food Score > 36
6) BMI<18.5 or BMI=30
7) Controlling body weight or have changed of body weight more than 4kg within 4 weeks before the first visit
8) Comply the following categories
- Have following diseases or taking relevant medicines: Systemic infection, severe cardiovascular disease (hypertension, stroke), digestive system disease, kidney disease, thyroid disease, autoimmune disease, malignant tumor, multisystem failure, inflammatory bowel disease, uncontrolled meantal illness, HIV
- Those who have received organ transplants and bone marrow transplants
- Those who taking steroids, antibiotics, and anti-inflammatory drugs (NSAIDs) continuously within 1 month before the first visit
- Therapeutic uses of coumadin, aspirin, or other medications that influence hemostasis within three weeks of the first visit.
9) Continuous consumption of health functional food(Coenzyme Q10,antioxidantsmultivitamin etc), and medicinal herbs 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) Pregnant or lactating women
13) Participation in other human study within 1 month before the first visit
14) 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
NameTimeMethod
antioxidant enzyme activity (Superoxide dismutase, catalase activity etc), oxidative stress marker (Thiobarbituric acid reactive substances, 8-hydroxydeoxyguanosine etc)
Secondary Outcome Measures
NameTimeMethod
Inflammation markers (tumor necrosis factor-a, interleukin-6 etc)
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