A human study to evaluate the safety and effectiveness of HemoHIM on exercise performance and fatigue improvement

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004905

Enrollment

100

Registered

2020-04-08

Start date

2020-04-30

Completion date

Unknown

Last updated

2020-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Subjects take a test food or placebo (40g of HemoHIM extract) twice a day for 8 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy adults men and women aged 30 to under 60 who complain of fatigue (28 or more on the fatigue scale)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
exercise performance examination;fatigue related indicators	—

Secondary

Measure	Time frame
Clinical pathology examination(Vital sings, clinical laboratory test)	—

Countries

Korea, Republic of

Contacts

Public ContactJun Hyun Bae

Seoul National University

Outcome results