Healthy subjects
Conditions
Interventions
12-week intake of the test food1
12-week intake of the test food2
12-week intake of the placebo food
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese men and women aged 50 to 69 years at the time of informed consent 2) Subject who is aware of cognitive decline 3) Subject who is able to take 3 capsules daily for 12 weeks. 4) Subject with an MMSE score of 24 or more 5) Non smoker 6) Subject who has received sufficient explanation of the purpose and content of the research, is capable of giving informed consent, voluntarily volunteers to participate in the research, and consents to participate in the research in writing.
Exclusion criteria
Exclusion criteria: 1) Subject who is currently receiving any medications or outpatient treatment. 2)Subject who is currently doing exercise or diet under the supervision of a doctor 3)Subject who is may develop allergy due to the test food 4)Subject who is drug dependent, present or dependent on alcohol 5) Subject who is history of psychiatry during hospitalization due to mental disorder (depression etc.) or sleep disorder (insomnia, sleep apnea syndrome etc.) 6)Night shift or shift workers 7) Excessively irregular lifestyle such as eating or sleeping 8) Subject who is extreme skipped eating 9)Subject who is current disease or history of diabetes, liver disease (hepatitis), kidney disease, serious disease such as heart disease, thyroid disease, adrenal disease, other metabolic diseases 10)Subject who is use health foods, supplements, and medicines that may affect cognitive function 11) Subject who is participated in other human clinical studies within the past 3 months or are expected to participate in other human clinical studies during the study period. 12)Subject who is carried out blood collection, component blood donation more than 400 mL within 200 mL or 3 months within one month going back from the date of consent acquisition 13) Subject who is pregnant, breast-feeding, or willing to become pregnant during the study period 14)Subject who is difficult to comply with the records of various surveys 15)Subject who is judged to be unsuitable as subject from clinical laboratory test value and measurement value at the time of SCR 16)Other than the above, the principal investigator judged that the subject was ineligible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitrax,MMSE | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index Uchida-Klepelin test Brain-derived neurotrophic factor Amyloid-beta (1-40, 1-42) Secreted Amyloid Precursor Protein-alpha Amyloid Precursor Protein 770 MicroRNA | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014
Outcome results
None listed