Healthy Adults
Conditions
Interventions
Ingest 3 tablets of the test foods (capsules containing polyamine) each after breakfast, lunch and dinner (total 9 tablets) daily for 12 weeks.
Ingest 3 tablets of the test foods (placebo) each after
Sponsors
Healthcare Systems Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document 2. Healthy Japanese who are 40 years old or more when obtaining consent 3. Persons who are aware of forgetfulness 4. Persons whose MMSE score is 24 or higher at screening
Exclusion criteria
Exclusion criteria: 1. Persons who have chronic illness, receiving medication, have a serious disease history 2. Patients suffering from cancer, familial colorectal adenomatosis, or H. pylori infection. 3. Persons who have any allergies to the ingredients used in the test food (especially persons who have allergies to wheat) 4. Persons who regularly take of polyamine-containing supplements 5. Persons who consume at least one pack of natto every day. 6. Persons who consume at least one pack of soy milk (approximately200ml) every day. 7. Persons who regularly use medicines or foods with health claims (foods for specified health use, foods with functional claims and foods with nutritional claims) etc., that may affect cognitive function. 8. Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam 9. Persons who were judged as inappropriate for study participants by the principal investigator 10. Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive function tests (Cognitrax) | — |
Secondary
| Measure | Time frame |
|---|---|
| Mini Mental State Examination Questionnaire regarding cognitive function (VAS) Blood pressure (Systolic, Diastolic and plus) Questionnaire regarding stress (VAS) Japanese Perceived Stress Scale Brief Job Stress Questionnaire Urine polyamine Blood polyamine | — |
Countries
Japan
Contacts
Public ContactKosei Nishikawa
Healthcare Systems Co., Ltd. Clinical Research Department
Outcome results
None listed