Verification study on the effects of intake of test foods on brain function.

Verification study on the effects of intake of test foods on brain function. - Verification study on the effects of intake of test foods on brain function.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000049524

Enrollment

100

Registered

2022-12-05

Start date

2022-12-06

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

None listed

Interventions

Daily intake of test food for 12 weeks Daily intake of placebo (control food) for 12 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy Japanese men and women who are 20 years of age or older at the time of consent. 2. Persons who are aware of memory or attention decline. 3. Persons who are suspected to have mild cognitive impairment (MCI) with a score of 24 to 29 on the MMSE screening test for dementia. 4. Persons who have signed a consent form prior to the start of the study upon full explanation of the purpose and content of the study.

Exclusion criteria

Exclusion criteria: 1. Persons with a pre-existing or current condition of liver disease, renal disease, cerebrovascular disease, diabetes, dyslipidemia, hypertension, or other chronic disease. 2. Persons who are on treatment for a serious illness. 3. Persons engaged in brain training, puzzles, etc. for the purpose of brain training. 4. Persons with food allergies or those who may be allergic to the test food. 5. Persons who regularly use licensed drugs or quasi-drugs that may affect the study. 6. Persons who regularly use health foods that may affect the study. 7. Persons who are participating in a clinical trial or have participated in another clinical trial within 3 months from the date of obtaining consent. 8. Smokers, or non-smokers who have not smoked within 3 months prior to the start of the study. 9. Persons unable to maintain daily routines. 10. Pregnant, lactating, or wishing to become pregnant. 11. Persons who plan to participate in other examinations during the study. 12. Other subjects who are deemed inappropriate for this study by the investigator.

Design outcomes

Primary

Measure	Time frame
Cognitrax	—

Secondary

Measure	Time frame
Brain Age Meter ATMT (brain age [brain vitality, quickness, effective use of brain], stress intensity, brain traffic) SF-36v2 POMS2 d-ROMs BAP Simple OSP (urinary 8-OHdG/creatinine corrected, PAO) Oxidized LDL	—

Countries

Japan

Contacts

Public ContactRyoko Koizumi

APO PLUS STATION CO., LTD. CRO Department Clinical Operations Division

food-contact@apoplus.co.jp03-6386-8809

Outcome results