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-.
- Conditions
- Adults
- Registration Number
- JPRN-UMIN000050219
- Lead Sponsor
- IMEQRD Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cognitrax basic: Composite Memory
- Secondary Outcome Measures
Name Time Method 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, BDHQ