None (Healthy adults)
Conditions
Interventions
Intakes of test tablets for 6 weeks
Intakes of placebo tablets for 6 weeks
Sponsors
Kirin Holdings Company, Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Men and women in good health who are between 45 and 64 years of age at the time of obtaining consent (2) Subjects whose first language is Japanese. (3) Subjects who often feel irritated or anxious in daily life. (4) Subjects who are not suspected of depression on the Beck Depression Questionnaire (BDI-II) (19 points or less) (5) Subjects who have received two or more doses of COVID-19 vaccine and more than one week has passed since the last dose at the time of obtaining consent.
Exclusion criteria
Exclusion criteria: Subjects (1) with high psychological health as a result of the GHQ28 (2) who showed significant fluctuations in the measured values of the major endpoints in the two pre-tests (3) who continuously consume medicines or foods fortified with the ingredients involved in functionality (4) who continuously take medicines or health foods to improve their mood, fatigue, stress, or sleep (5) who regularly engage in activities aimed at improving mood, fatigue, stress, and sleep (6) who are unable to use the prescribed applications on their smartphones or cooperate with web surveys (7) whose working days are irregular (8) whose life is irregular several times during the research period (9) whose lives are scheduled to undergo major changes during the research period (10) who are heavy drinker (11) who are undergoing treatment for, have a history of, or are suspected of having a mental disorder (12) who are suffering from or aware of sleep-related illnesses (13) who have been diagnosed with chronic fatigue syndrome (14) who may have physical deconditioning due to test foods (15) who regularly smoke or who started smoking cessation within 12 months (16) who have donated 200 or 400 mL of whole blood or had a blood transfusion within 3 months prior to the pre-test (17) who have participated in other clinical trials within 1 month prior to the pre-test, or who plan to participate during the study period (18) who have a disease that requires constant medication (19) who are judged unsuitable as subjects by the Chief Medical Officer based on the clinical examination values (20) who are pregnant, lactating, or planning to become pregnant or lactate during the study period (21) who are judged to be unsuitable as subjects based on their responses to the preliminary questionnaire (22) who work for a company that develops or manufactures functional foods, either by themselves or by a family member living with them (23) who are judged unsuitable as subjects by the Chief Medical Officer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mood states (trait-anxiety, perceived stress, apathy, mental health, vitality, calmness of mind) | — |
Secondary
| Measure | Time frame |
|---|---|
| Mood states (state-anxiety, depression), health-related quality of life, blood indicators | — |
Countries
Japan
Contacts
Public ContactTakashi Nakagawa
EP Mediate Co., Ltd. Food Department, Trial Planning Section
Outcome results
None listed