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Confirmatory study of the efficacy and effectiveness of egg consumption on cognitive function improvement in Japanese adults - A placebo-controlled, double-blind, randomized, comparative trial-.

Confirmatory study of the efficacy and effectiveness of egg consumption on cognitive function improvement in Japanese adults - A placebo-controlled, double-blind, randomized, comparative trial-. - Confirmatory study of the efficacy and effectiveness of egg consumption on cognitive function improvement in Japanese adults.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000050219
Enrollment
100
Registered
2023-02-07
Start date
2023-04-10
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

Adults

Interventions

Take a piece of the test diet twice a day, one after breakfast and the other between lunch and dinner. Take a piece of the control diet twice a day, one after breakfast and the other between lunch and

Sponsors

IMEQRD Co., Ltd
Lead Sponsor
The University of Tokyo Kewpie Corporation Tokyo Medical University School Of Medicine Alumni Association Kanagawa Institute of Industrial Science and Technology CPCC Company Limited
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese male or female aged 55 years or older and less than 80 years at the time of consent. 2. Have a sense of forgetfulness or receive an objective suggestion. 3. MMSE-J score equal to or above 24 at the SCR. 4. Every validity indicator for the Cognitrax score, including Composite Memory, Verbal Memory, and Visual Memory, is "yes". 5. Has a relatively low Composite Memory score on the Cognitrax test. 6. Can write an electronic daily log using smartphones or PCs. 7. Received an adequate explanation of the purpose of the study and voluntarily participated in the study under informed consent.

Exclusion criteria

Exclusion criteria: 1. Taking foods or dietary supplements with functional health claims that may affect the outcome of the study, such as FOSHU, and FFC, more than three times per week and are unable to discontinue taking these foods after the time of consent. 2. Are regularly taking medications that may affect the outcome of the study, such as antibiotics, bowel preparations, laxatives, and medications for psychiatric disorders, and are unable to limit the use of these medications after the time of consent. 3. Are diagnosed with lipidemia, and receive treatment. 4. Are diagnosed with dementia, and receive treatment. 5. Heavy drinker, greater than or equal to 60 grams of alcohol per day. 6. Have irregular eating habits or rhythm of daily life. 7. Have intense regular exercise habits. 8. Voluntarily take bluefish such as sardines, mackerel, and saury. 9. Have an egg intake amount greater than or equal to 14 per week in daily life. 10. Daily use of brain-training materials that may affect cognitive function, such as devices, digital applications, or games. 11. Serious heart, liver, renal, or gastrointestinal disease or a history of such disease. 12. Allergies to any medications or foods. 13. Are currently participating in other clinical trials, plan to participate in other clinical trials three months after the end of the study, plan to participate in other clinical trials after consenting to the study, and experienced the Cognitrax six months before consenting to the study. 14. Have donated more than 200 mL of blood within one month before the start of the study. 15. Have a blood donation volume greater than 1200 mL, which is the sum of the planned blood donation volume in the study and the previous blood donation volume within 12 months before the start of the study. 16. Unsuitable for the study, as determined by the investigator.

Design outcomes

Primary

MeasureTime frame
Cognitrax basic: Composite Memory

Secondary

MeasureTime frame
Cognitrax basic: Verbal Memory, Visual Memory, Psychomotor Speed, Response Time, Complex Attention, Cognitive Flexibility, Process Speed, Executive Function, Simple Attention, and Motor Speed. Trail Making Test Japanese Version (TMT-J) Other outcomes: miRNA measurement, BDHQL

Countries

Japan

Contacts

Public ContactYoshitada Hira

IMEQRD Co., Ltd. Planning and Sales Department

clinical-trial@imeqrd.co.jp0367045968

Outcome results

None listed

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