A human study to evaluate the safety and effectiveness of HemoHIM on exercise performance and fatigue improvement
- Conditions
- Not Applicable
- Registration Number
- KCT0004905
- Lead Sponsor
- Seoul National University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 100
Healthy adults men and women aged 30 to under 60 who complain of fatigue (28 or more on the fatigue scale)
1) Subject who is unable to perform cycle ergometer test
2) Subject who constantly exercised (moderate or high-intensity) for 3 months prior to the first visit
3) Those with a high level of cardiopulmonary endurance (maximum oxygen consumption of 1st and 2nd grade of 50% depending on age)
4) Subject has a body mass index (BMI) of 18.5 kg / m2 or less or 30 kg / m2 or more
5) Subject is over alcoholic
6) Smoker and drug addict
7) Insomnia
8) Subject have any of the following (including past medical history) or are taking any related medicines: hyperlipidemia, asthma, musculoskeletal disorder and etc
9) Subject who had a surgical operation 6 months prior to the first visit
10) Subjects who consumed oriental medicine within 1 month prior to the first visit
11) Subjects who consumed functional foods or related food to affect physical performance and fatigue (health supplements, fatigue recover supplements and so on)
12) Subject with hypersensitivity to the test food or ingredients contained in the test food
13) Subject who are pregnant or lactating women
14) Subject in other clinical trials within one month of the first visit or plan to participate in other clinical trials during this human study period
15) Subject unable to use smartphone
16) Any condition that the principal investigator believes the subject is unsuitable for this study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method exercise performance examination;fatigue related indicators
- Secondary Outcome Measures
Name Time Method Clinical pathology examination(Vital sings, clinical laboratory test)