None listed
Conditions
Interventions
Dietary Supplement : Test Group 1: L-Arginine 3 g / Twice a day, 1 sachet per intake / Duration: 8 weeks
Test Group 2: L-Arginine 6 g / Twice a day, 1 sachet per intake / Duration: 8 weeks
Control Gro
Sponsors
Daejeon University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult males and females aged 30 to under 60 years who experience usual fatigue. 2) Individuals with mild fatigue (Fatigue Severity Scale [FSS] total score of 27 or higher). 3) Individuals whose maximal oxygen uptake (VO2max) is within the range between the top 15% and the bottom 25% (Excluding those who exceed the top 15% and those who fall below the bottom 25%, based on the Korean physical fitness percentile data of the National Fitness Award 100 project).
Exclusion criteria
Exclusion criteria: 1) Medication Use • Individuals diagnosed with drug addiction by a physician. • Individuals with a history of alcohol and other drug abuse within 1 year prior to screening. • Individuals who have continuously consumed health functional foods or products that may affect exercise performance or fatigue (fitness supplements, fatigue recovery products, complex health functional foods containing vitamin C, vitamin B complex, magnesium, potassium, calcium, etc.) within 1 month prior to the first visit. 2) Disease Status • Liver disease: Individuals with a liver disease requiring treatment, or with AST or ALT levels 3 times or more the upper limit of normal (ULN), or Serum Bilirubin levels 2 times or more the ULN. • Individuals with eGFR 7.0 %). • Individuals with hypotension (SBP 140 mmHg or DBP > 90 mmHg). • Individuals with a history of malignant tumors within the past 5 years. • Individuals with tuberculosis, multiple sclerosis, hypothyroidism, or asthma uncontrolled by medication. • Individuals with a diagnosed history of major depressive disorder, bipolar affective disorder, schizophrenia, dementia, delusional disorder, or insomnia. • Individuals with a Body Mass Index (BMI) of 18.5 kg/m2 or less, or 35.0 kg/m2 or more. 3) Other General Factors (Physiological, Lifestyle, Allergic Reactions, etc.) • Night shift workers. • Individuals unable to perform treadmill exercises. • Women who are pregnant, breastfeeding, or planning to become pregnant during this human clinical trial period. • Excessive alcohol consumption (Men: 40 g or more per day, Women: 20 g or more per day). • Heavy smokers (20 or more cigarettes/day). • Individuals who have continuously engaged in high-intensity exercise or higher within 3 months prior to the first visit. • Individuals with excessive usual protein intake (those who have continuously consumed protein supplements, eggs, milk, etc., for the purpose of protein intake other than regular meals for more than 1 month), or vegetarians. • Individuals with known allergies/adverse reactions to the test substance. • If arrhythmia findings, such as 2mm ST-segment depression, asystole, threshold limit of 3 seconds, ventricular fibrillation/flutter, ventricular tachycardia, premature ventricular contractions (minimum of 3 consecutive PVCs), or ventricular couplets (2 consecutive PVCs), are observed during the exercise stress test electrocardiogram (ECG), eligibility will be determined based on the judgment of a specialist or the principal investigator. • Individuals deemed unsuitable for the human clinical trial by the principal investigator (e.g., if the clinician determines a causal relationship with a disease through the medical interview).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue Severity Scale (FSS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Checklist Individual Strength(CIS), Multidimensional Fatigue Scale(MFS), Visual Analogue Scale(VAS);Improvement in exercise-induced fatigue (Lactate, Glucose, LDH, etc.);Pittsburgh Sleep Quality Index_Korean version (PSQI-K);Adverse Event;Vital Signs;Clinical Laboratory Test;Pregnancy Test | — |
Countries
Korea, Republic of
Contacts
Public ContactEunbum Kang
Daejeon University
Outcome results
None listed