A human study to evaluate of efficacy and safety of EFR on immune functio
- Conditions
- Factors influencing health status and contact with health services
- Registration Number
- KCT0006255
- Lead Sponsor
- Bundang Jesaeng Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
1) Subject who voluntarily agrees to participate and signs in informed consent form
2) Healthy people, 20 = age < 70.
3) Stress self assessment scaled above strong
4) Subjects suffered from upper respiratory track infection or cold-related symptoms which have possibilities to
cause upper respiratory track infection more than two times in the past one year.
5) White blood cell(WBC) ranged normal”
1) Patients who was diagnosed and are currently in the treatment of diabetes
2) Subjects who are currently in the treatment of significant clinical disease related to acute or chronic cardiovascular system, immune system, respiratory system, liver biliary, kidney and urinary tract, nervous system, musculoskeletal disorders, psychic, infection and blood neoplastic.
3) Subjects who have medical history with myocardial infarction or cerebrovascular disease within 6 months.
4) Subjects who have a neurologically or psychologically important medial history or who is currently suffering from a disease.
5) Subjects who have uncontrolled high blood pressure.
6) Subjects whose AST or ALT exceeds 3 times of normal range.
7) Subjects whose creatinine exceeds 2 times of normal range.
8) Subjects who have complained of severe gastrointestinal symptoms such as heartburn, indigestion.
9) Subjects who got a vaccination within 1 months before screening.
10) Excessive smoker
11) Subjects who usually consume alcohol as follows - men: 210g/week, women 140g/week
12) Subjects whose BMI is under 18.5 or exceeds 30.0
13) Subjects who continue to consume beta-glucan or rice bran-containing food within one month of their first visit
14) Subjects who have intaken or is intaking functional foods
15) Subjects who are planning to participate other studies within one month of their first visit
16) Subjects who are pregnant or breastfeeding or planning a pregnancy.
17) Subjects who are sensitive to test foods/algae or have food allergies.
18) Subjects who are deemed to be inappropriate to this study.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method K cell activity (%) et al.
- Secondary Outcome Measures
Name Time Method Adverse events et al.