Healthy adults
Conditions
Interventions
L-theanine 200mg/day, gamma-aminobutyric acid 700mng/day for 4weeks
Sponsors
Hiroyuki Konno, Japan Brain-Care Dementia Prevention Research Center.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Females/males aged between 20 and 64 years who are aware of problems related to sleep. (2) Those with a BMI of between 18.5 and 25.0 kg/m2. (3) Those with a score of 6 or more on the Pittsburgh sleep quality index. (4) Those who are able to wear Fitbit Charge 5 during the study period, including at bedtime. (5) Those who can give written voluntary consent to participate in the study.
Exclusion criteria
Exclusion criteria: (1) Those who are currently diagnosed with insomnia or sleep disorders and are undergoing some kind of medical treatment. (2) Those who consume food or supplements containing L-theanine or gamma-aminobutyric acid. (3) Those who regularly use health foods or supplements that affect sleep. (4) Those with serious diseases such as glucose metabolism related disease, lipid metabolism related disease, liver disease, renal disease, cardiovascular disease, gastrointestinal disease, respiratory disease, hematological disease, autoimmune disease, endocrine system disease, metabolic system disease. Or those with a history of such diseases. (5) Those with a history of drug allergy or serious food allergy. (6) Those who have had abnormal laboratory values within the past year and have been considered to have problems participating in the study. (7) Those who have a disease that is currently undergoing medical visit, medical treatment, use of medication, or follow-up. (8) Those who are considered to be inappropriate as subjects based on the results of the questionnaire on the background of the subjects. (9) Those who are participating in other clinical studies at the start of this study. (10) Those who are pregnant or plan to become pregnant or breastfeed during the study period. (11) Those who are considered inappropriate to participate in the study by the study investigator (or the person in charge of the contract research organization).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh sleep quality index | — |
Secondary
| Measure | Time frame |
|---|---|
| State-Trait Anxiety Inventory Health-related data collected by Fitbit Charge 5 Adverse event | — |
Countries
Japan
Contacts
Public ContactKazumi Naganuma
DRC Co., LTD. Cosmetics and Food Usefulness Test Group, Testing Department
Outcome results
None listed