Healthy male/female adults
Conditions
Interventions
Consumption of the test food to the subjects, 2 drops a day (one drop each at breakfast and dinner).
Consumption of the placebo food to the subjects, 2 drops a day (one drop each at breakfast and dinn
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Japanese male/female subjects ranging in age from 55 to 79 at informed consent. (2) Subjects fully realized that the subjects themselves must be in forgetfulness, or have been pointed out such tendency. (3) Subjects having a MMSE-J score of not less than twenty-six. (4) Subjects who can give informed consent to participate in this trial, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: (1) Subjects who take steadily (not less than three times a week) in the health-specific/functional/supplementary/health foods which might affect this trial, and will have any difficulty in giving up taking them after the consent. (2) Subjects who have taken affecting medicines (e.g., dementia medication), and have any difficulty in refraining from taking them during this trial. (3) Subjects being under medical treatment for dementia, after diagnosis. (4) Subjects with excessive alcohol intake. (5) Subjects with extremely irregular eating habits, and ones having an irregular life rhythm. (6) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. (7) Subjects having some kind of drug and/or food allergy. (8) Subjects who are under other clinical trials with some kind of medicine/food, or participated in those within the last four weeks before this trial, or are planning to join those after the consent. (9) Subjects who donated their blood components and/or whole blood (200 mL) within a month to this trial. (10) Males who donated their whole blood (400 mL) within the last three months to this trial. (11) Females who donated their whole blood (400 mL) within the last four months to this trial. (12) Males who will be collected in total of their blood (1200 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial. (13) Females who will be collected in total of their blood (800 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial. (14) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitrax bacic ver. (total score of the points from verbal memory, visual memory, finger tapping, symbol digit coding, stroop, shifting attention, and continuous attention) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Amyloid-beta in blood 2. The Profile of Mood States Second Edition (Japanese short ver.) | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Clinical Planning Department
Outcome results
None listed