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To evaluate the effect of food ingredient on cognitive functions.

To evaluate the effect of food ingredient on cognitive functions. - To evaluate the effect of food ingredient on cognitive functions.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000045050
Enrollment
60
Registered
2021-08-04
Start date
2021-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adults

Interventions

Ingestion of food ingredient (0.3 g/day). Duration: 12 weeks. Administration: Take once a day. Ingestion of placebo. Duration: 12 weeks. Administration: Take once a day.

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Males and females from 60 to 80 years of age. 2.Subjects who get 26 or more in score of Mini Mental State Examination-Japanese (MMSE-J) 3.Subjects who are experiencing memory loss. 4.Subjects 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.Subjects who have mental health issues such as depression disorder or other issues and medical history or treatment of cerebrovascular disease. 2.Subjects who get 6 or more in score of The Geriatric Depression Scale-Short Form-Japanese (GDS-S-J). 3.Subjects who take medicines that may affect the central nervous system, except sleeping pills. 4.Subjects who take supplements related to improving cognitive functions. 5.Subjects who have visual impairment or hearing impairment. 6.Subjects who have serious liver, kidney, heart, respiratory, endocrine, or metabolic diseases. 7.Heavy smoker ,drinker of alcohol or subjects with disordered lifestyle. 8.Subjects who are allergic to medicines and/or the test food related products. 9.Subjects who constantly use or who can't restrict use medicines (related to Antipsychotics, anxiolytics, antidepressants, antiparkinson's drugs, antidepressants, antiepileptics, anticoagulants, etc.) having a possibility of affecting test results. 10.Subjects who constantly use or who can't restrict use supplements, vitamins and nutrient (related to blood flow and antioxidant effect) having a possibility of affecting test results. 11.Subjects who are participating the other clinical tests. 12.Others who have been determined ineligible by principal investigator or sub-investigator.

Design outcomes

Primary

MeasureTime frame
Cognitive function test score * Assessed by Cognitrax * Perform Cognitrax at before consuming and at 6 and 12 weeks after ingestion

Secondary

MeasureTime frame
TMT-A, B SF-36v2 WHO-5 OSA Sleep Inventory Evaluation of blood parameter values

Countries

Japan

Contacts

Public ContactEiji Yoshikawa

KSO Corporation Sales department

yoshikawa@kso.co.jp03-3452-7733

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026