Healty volunteers
Conditions
Interventions
Ingestion of test food A for 12 weeks.
Ingestion of test food B for 12 weeks.
Sponsors
Nikorio Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Japanese males and females who are between 55 and 80 years of age. 2) People who are aware that they forget things, or who have been told by others that they forget things 3)People who are not receiving treatment for an illness. 4)Those who understand the contents of the clinical trial, wish to participate in the trial, and can provide written consent. 5)Those who can maintain a consistent daily lifestyle during the clinical trial
Exclusion criteria
Exclusion criteria: 1) Those who have been taking medicines regularly within 3 months prior to the start of the clinical trial (excluding temporary medications such as painkillers and cold medicines). 2) Are diagnosed with serious illness (diabetes, heart disease, liver disease, kidney disease, cancer, etc.) or mental illness. 3) Have a history of serious illness. (diabetes, heart disease, liver disease, kidney disease, cancer, etc.) 4) Those who have been using foods for specified health uses, foods with functional claims, or supplements more than three times a week within the three months prior to the start of the study that may affect the clinical trial. 5) Those who are unable to stop taking foods for specified health uses, foods with functional claims, or supplements during the clinical trial period, which may affect the clinical trial. 6) Those who have been diagnosed with dementia or are undergoing treatment for dementia. 7) Those who drink a lot of alcohol (40g or more of pure alcohol per day on average). 8) Those with extremely irregular eating habits or those who work night shifts or have other irregular lifestyles. 9) Allergies to any medications or test foods. 10) Those who participated in clinical trials of cognitive or brain function within 6 months of the start of this clinical trial. 11) Those who are currently participating in a clinical trial of another drug or health food, have completed the trial within 4 weeks, or plan to participate in another clinical trial while participating in this trial. 12) Others who have been determined ineligible by principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive function test (Cognitrax: Basic) | — |
Secondary
| Measure | Time frame |
|---|---|
| Defecation status (frequency of bowel movements, amount of stool, shape of stool, feeling of incomplete bowel movement, abdominal pain during defecation, odor) Blood biochemistry test, hematology test | — |
Countries
Japan
Contacts
Public ContactTatsuo Uetake
CXwellness, Inc. Representative Directo
Outcome results
None listed