Fatigue, sleep problems, mood swings, and trouble thinking clearly
Conditions
Interventions
treatment group:Test food consumption,Hexa Time Capsule
Sponsors
The First People's Hospital of Kunshan
Eligibility
Sex/Gender
All
Age
30 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 30-50 (inclusive), evenly split between men and women; 2. Fatigue Severity Scale (FSS) total score >=18 and =11; 4. Determined to be a mildly to moderately sub-healthy group according to the Sub-Health Measurement Scale (SHMS V1.0); 5. Can cooperate with researchers to independently complete all research tests and questionnaires; 6. During the study, participants agree not to take part in other interventional studies; 7. Voluntarily join the study, sign the informed consent form before the study, fully understand the study’s content, process, and any possible adverse events, and be willing to follow the study’s requirements and procedures;
Exclusion criteria
Exclusion criteria: 1.Women Preparing for Pregnancy, Pregnant Women, and Lactating Women; 2.Suffering from severe organic diseases, metabolic diseases, infectious diseases, trauma, mental disorders, or cognitive impairments; having a history of tuberculosis; having a history of major surgery; 3.Have been taking medication regularly in the past 3 months (at least twice a week for more than a month). 4.Those whose physical examination results within the past 3 months meet any of the following conditions need to be excluded: a. Liver function: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal (ULN). b. Kidney function: Serum creatinine > 1.2 times the upper limit of normal (ULN). c. Others: The investigator determines the presence of other laboratory abnormalities with clear clinical significance that may affect the safety of study participants or the reliability of study results. 5.In the past week, the average daily intake of caffeine exceeded 400 mg (approximately 800 mL of American coffee). 6.Regular consumption of mushrooms, legumes, or oat bran in the past month (defined as =3 times per week); 7.Habitual heavy drinking, with an average alcohol intake of >2 standard drinks/day (beer >500ml/day, red wine >200ml/day, spirits >50ml/day); 8.Smokes more than 10 cigarettes a day; 9.Regularly taking nutritional supplements in the past month (defined as at least 3 times a week); 10.Known to be allergic to the study components, or have a history of drug allergies or allergic diseases; 11.People who have trouble swallowing capsules; 12.People working night shifts; those planning to make big changes to their schedule during the study (like going on overseas trips or traveling); 13.Other conditions that, according to the researcher’s judgment, are not suitable or would hinder participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue Severity Scale (FSS) Score, Pittsburgh Sleep Quality Index (PSQI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-Rated Sleep Status Scale (SRSS), Depression-Anxiety-Stress Scale, Clinical Memory Scale, Stroop Test, Health Survey Short Form, 6-Minute Walk Test, Mini-Mental State Exam, Self-Assessment Questio;Visceral fat;C-reactive protein (CRP), interleukin-6 (IL-6);Waist and belly measurements;Complete blood count, urinalysis, liver function (alanine aminotransferase, aspartate aminotransferase), kidney function (creatinine);Gut microbiota diversity (Alpha diversity index), relative abundance of gut microbiota; testing gut short-chain fatty acids (acetate, propionate, butyrate);8-Hydroxy-2'-deoxyguanosine (8-OHdG), glutathione peroxidase (GSH-Px), superoxide dismutase (SOD).;Melatonin; | — |
Countries
China
Contacts
Public ContactGuo Zhengli
The First People's Hospital of Kunshan
Outcome results
None listed