A dose finding study on the effect of continuous intake of test foods on the cognitive function. -a randomized, double-blind, parallel-group comparison trial-

A dose finding study on the effect of continuous intake of test foods on the cognitive function. -a randomized, double-blind, parallel-group comparison trial- - A dose finding study on the effect of continuous intake of test foods on the cognitive function. -a randomized, double-blind, parallel-group comparison trial-

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000046397

Enrollment

Registered

2021-12-19

Start date

2021-12-20

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

Take six tablets of the test food (high dose) after breakfast once every day for 12 weeks Take six tablets of the test food (low dose) after breakfast once every day for 12 weeks Take six tablets of t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged between 65 and less than 80 years old. 2. Japanese males and females. 3. Those who have subjective symptoms of cognitive decline and are judged by the investigators to have no problem participating in the study. 4. Those who were not pointed out high blood pressure at medical checkup. 5. Those who can input their own data into the electronic diary. 6. Those who received sufficient explanation for the objective and summary of the trial, and voluntarily volunteered to the trial with the agreement of informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who are receiving any types of medicines and/or Chinese medical treatment. 2. Those who are managed by medical doctors for diet/exercise therapy. 3. Those who have severe diseases or a history of severe diseases. 4. Those who have strabismus, cataracta, or have surgical history of eye within 1year ago from the date of consent. 5. Those who have currently been taking commercially available drugs, quasi-drug products, and foods or supplements with functional claims. 6. Those who have a drug/food allergy. 7. Those whose MMSE-J score are less than 24, or over 29. 8. Those who drink more than 60 g alcohol/day. 9. Those who have excessive smoking habits (21 or more cigarettes / day) 10. Those who are planning extremely change their lifestyle during the trial. 11. Those who are planning travel to foreign countries during the trial. 12. Those who joined other clinical trials from 1 month before this trial, or those who have currently been joined or planning to join other clinical trials. 13. Those who are unsuitable for this trial, that judged by the principal investigator.

Design outcomes

Primary

Measure	Time frame
Cognitive function test (eye-tracking test)	—

Secondary

Measure	Time frame
Cognitive function test (MMSE-J), QOL questionnaire	—

Countries

Japan

Contacts

Public ContactHirokuni Kayama

IMEQRD Co., Ltd Planning and Sales Department

clinical-trial@imeqrd.co.jp03-6704-5968

Outcome results

None listed

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