None listed
Conditions
Interventions
Dietary Supplement : Treatment group: HH-205M, once a day, for 8 weeks, oral administration
Control group: placebo sachet, once a day, for 8 weeks, oral administration
Sponsors
Inha University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged between 35 and 65 years 2) A person with a total score of 27 or higher on the Fatigue Severity Scale (FSS) 3) A person who has agreed to participate in this clinical trial before its start and has signed the written Informed Consent Form (ICF)
Exclusion criteria
Exclusion criteria: 1) A person currently undergoing treatment for severe cardiovascular, immune, respiratory, hepatobiliary, renal and urinary, nervous, musculoskeletal, psychiatric, infectious diseases, or malignancies. 2) A person with a history of malignancy within 5 years prior to Visit 1. 3) A person who has received medical treatment within 6 months prior to Visit 1 for any disease that could be a direct cause of chronic fatigue. 4) A person with a history of surgical procedures within 6 months prior to Visit 1. 5) A person suspected of or with a history of anorexia or bulimia. 6) A person with fatty liver requiring treatment for hepatitis or liver cirrhosis. 7) A person with a BMI of 18.5 kg/m^2 or lower, or 35 kg/m^2 or higher. 8) A person unable to perform an exercise stress test. 9) A person whose VO2max is in the top tier for their age group according to the exercise stress test. 10) A person who has undergone professional exercise therapy, counseling, or similar interventions to improve chronic fatigue within 2 months prior to Visit 1. 11) A person who has taken drugs, functional foods, health supplements, or herbal medicines to improve chronic fatigue or exercise performance within 1 month (30 days) prior to Visit 1. 12) A person who has taken vitamins within 2 weeks prior to Visit 1. 13) A person who has taken immunosuppressants, sedatives, antidepressants, sleeping pills, or antihistamines within 2 weeks prior to Visit 1. 14) A person who has taken digestive aids, antibiotics, probiotics, prebiotics, or consistently (4 times a week or more) consumed fermented milk or lactic acid bacteria products within 2 weeks prior to Visit 1. 15) A person engaged in night shifts, shift work, or heavy overlapping work. 16) A person who has been regularly exercising (at least 3 days a week, 30 minutes per day, to the point of shortness of breath) within 3 months prior to Visit 1. 17) A person with a history of alcohol abuse or chronic alcohol consumption* or a history of other substance abuse. *Defined as consuming an average of 40g or more of alcohol per day (280g/week) for men, or 20g or more of alcohol per day (140g/week) for women. 18) A person who is an excessive smoker (20 or more cigarettes per day). 19) A person whose AST (GOT) or ALT (GPT) levels are more than 3 times the upper limit of normal for the testing institution. 20) A person with an eGFR 7.0%). 23) A person with a TSH level of = 0.1 µIU/mL or = 10 µIU/mL. 24) A vegetarian. 25) A person who is pregnant, breastfeeding, or planning to become pregnant during the trial period. 26) A person who has participated in another interventional clinical trial (including human application trials) within 3 months prior to Visit 1 or plans to participate in another interventional clinical trial (including human application trials) after the start of this trial. 27) A person sensitive to or allergic to the ingredients of the food used in this trial. 28) A person deemed unsuitable by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FSS | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood indicators;Exercise Stress Testing(VO2max, RER, RPE, Exercise duration);KSF-36 | — |
Countries
Korea, Republic of
Contacts
Public ContactHye Kyung Park
Inha University Hospital
Outcome results
None listed