Males and females aged 55 to 80 years old
Conditions
Interventions
Take one capsule of the test food per day with water or lukewarm water for 12 weeks.
Take one capsule of the control food per day with water or lukewarm water for 12 weeks.
Sponsors
Nicorio Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Males and females aged 55 to 80 years old at the time of consent. (2) Subjects who are aware of forgetfulness or have been told they have forgetfulness. (3) Subjects whose MMSE-J score of 24 or higher before the pre-test and intake. (4) Subjects who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: (1) Subjects who are having Food for Specified Health Uses (FOSHU), Foods with functional claims and/or health foods, including supplements, etc. at least three times a week for three months prior to the date of consent, which may affect this study. (2) Subjects who are unable to stop ingesting foods for Specified Health Uses (FOSHU), Foods with functional claims and/or health foods, including supplements, etc. that may affect this study from the time of obtaining consent (3) Subjects who are taking medicines that may affect the study (dementia medication, antibiotics, laxatives, intestinal regulators, etc.) and cannot limit their intake during the study period. (4) Subjects who have been diagnosed with dementia and are receiving treatment. (5) Subjects who have extremely irregular eating habits or lifestyles. (6) Subjects who are participating, participated within the last four weeks before this study, or are planning to participate another clinical study of medication or health food. (7) Heavy drinkers. (8) Subjects who are aware that they have color vision deficiency (including those who have been diagnosed with color vision deficiency in the past). (9) Subjects who have past and present medical history of serious diseases of brain, heart, liver, kidney, digestive organs, and/or thyroid gland, etc. (10) Subjects who are allergic to drugs or foods (especially salmon). (11)-(15) Subjects who have donated a lot of whole blood and/or blood components within the last 12 months prior to this study. (16) Subjects who have been determined ineligible by principal investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive function (Cognitrax Basic) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy evaluation item BDNF in blood Self-report dementia checklist The Profile of Mood States Second Edition(Japanese short ver.) Defecation status(frequency, the number of days, quantity, property, feeling of incomplete evacuation, abdominal pain, fecal odor) Physical measurements(weight, BMI) Blood biochemistry test Safety evaluation items Adverse events and side effects Physiological tests Hematological tests General urine tests | — |
Countries
Japan
Contacts
Public ContactMasanori Numa
CPCC Company Limited Clinical Planning Department
Outcome results
None listed