Sleep quality
Conditions
Interventions
Trial Group 1:Take an oral product containing 100mg of GABA powder: Specification: 2g per sachet, once daily, one bottle per dose, taken continuously for 28 days.
Trial Group 2:Take an oral product containing 300mg of GABA powder: Specification: 2g per sachet, once daily, one bottle per dose, taken continuously for 28 days.
Trial Group 3:Take the oral powder supplement containing 100mg GABA + 20mg EGT: Specification: 2g per sachet Dosage: Once daily Pack size: One bottle per dose Duration: Take continuously for 28 days.
Placebo control group:Oral product containing only maltodextrin and glucose: 2g per sachet, once daily, one bottle per dose, taken continuously for 28 days.
Sponsors
Xiamen University
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Undergone a health examination at the Health Examination Centre of Shanghai Tongren Hospital, affiliated with Shanghai Jiao Tong University School of Medicine, with all specified indicators within normal ranges; 2. Permanent residents of Shanghai, of any gender, aged between 20 and 65 years inclusive (including 20 and 65 years); 3.Volunteers experiencing sleep quality issues with a Pittsburgh Sleep Quality Index (PSQI) score >=6; 4. Possess the means and capability to regulate bedroom temperature to a level conducive to sleep; 5. Have fully understood the purpose, content, and relevant matters of this trial, and have signed an informed consent form prior to trial commencement.
Exclusion criteria
Exclusion criteria: 1. Individuals suffering from severe organic diseases (such as heart, liver, lung, kidney, or digestive system disorders), diabetes mellitus, or hypertension; 2. Individuals with conditions that may cause sleep disturbances, including: snoring, sleep apnoea syndrome, restless legs syndrome, periodic limb movements during sleep, depression, or recurrent narcolepsy; 3. Individuals with psychiatric disorders. Those with a history of psychiatric treatment within the past year, including use of hypnotics, sedatives, or antipsychotic medications (e.g., zopiclone, benzodiazepines); 4. Beck Depression Inventory-II (BDI-II) total score >=20, or score >=1 on item 9 (concerning suicidal ideation); 5. Long-term or recent use of medications that may affect sleep or trial outcomes (e.g., corticosteroids, histamines, stimulants, hormonal agents); 6. Regular consumption of specific health foods, functional foods, or supplements that cannot be discontinued during the trial period; 7. Irregular daily routines, such as night shift work, rotating shifts, or physically demanding labour; 8. Individuals with smoking habits, or those consuming excessive alcohol (>=3 drinks/day or >=6 drinks/week) or caffeine (>=3 caffeinated beverages/day); 9. Body Mass Index (BMI) outside the normal range of 18.5 to 25.0; 10. Known allergies to metals, skin sensitivities, or history of food allergies, particularly concerning potential sensitivity to trial food components; 11. Currently pregnant, breastfeeding, or planning to conceive during the trial period; 12. Having undertaken extended travel or prolonged stays in countries with significant time zone differences within the past month; 13. Having participated in other clinical trials within the past month, or currently enrolled in another trial; 14. Possessing any other factors deemed unsuitable for trial participation following assessment by the study physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Polysomnographic testing; | — |
Secondary
| Measure | Time frame |
|---|---|
| Survey on Lifestyle Habits;Emotional Assessment;Physical examination; | — |
Countries
China
Contacts
Public ContactHongwei Li
School of Public Health, Xiamen University
Outcome results
None listed