None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Voluntary participants who are required to perform continuous work for a relatively long period of time, nearly 3 months, or who are prone to fatigue, as determined by the Chronic Fatigue Scale, aged 18-45 years.
Exclusion criteria
Exclusion criteria: 1. Individuals with serious cardiovascular or cerebrovascular diseases, severe hepatic, renal, or gastrointestinal disorders, or psychiatric illnesses. 2. Individuals with metabolic syndrome or related chronic conditions, including diabetes mellitus, hypertension, or obesity. 3. Individuals with an allergic predisposition or known hypersensitivity to any component(s) of the investigational product. 4. Individuals with severe insomnia or marked difficulty initiating sleep. 5. Individuals who have consumed substances relevant to the study outcomes within the past month, or used probiotics or antibiotics that could affect result interpretation, or who have had infection, surgery, or metabolic disorders within the past 3 months. 6. Individuals who do not consume the investigational product as specified, or whose data are incomplete and may compromise the evaluation of efficacy or safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rating of Perceived Exertion (RPE) Scale;Cognitive performance related to mental fatigue (attention and visual scanning ability);Maximal oxygen uptake (VO2max);Pittsburgh Sleep Quality Index (PSQI) score;Mood State Questionnaire (Profile of Mood States, POMS);Blood lactate, F2-isoprostanes, and brain-derived neurotrophic factor (BDNF);mtDNA copy number, serum lipidomic and metabolomic profiles, and genome-wide DNA methylation profiles related to mitochondrial metabolism; | — |
Secondary
| Measure | Time frame |
|---|---|
| Thyroid hormones, cortisol, dehydroepiandrosterone (DHEA), and testosterone;C-reactive protein (CRP) and inflammatory cytokines;Mental status, sleep, diet, bowel and urinary habits, blood pressure;Routine blood and urine tests, as well as liver and renal function tests;Gut microbiota diversity; | — |
Countries
China
Contacts
West China School of Public Health and West China Fourth Hospital, Sichuan University