NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000045684

Registered date:10/10/2021

An interventional study for verifying recognition-improving effects by ingesting a whole egg

Basic Information

Recruitment status Pending
Health condition(s) or Problem(s) studiedHealthy male/female adults
Date of first enrollment2021/10/10
Target sample size100
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Ingestion of the test-food to the volunteers one a day for twelve weeks. Ingestion of the placebo-food to the volunteers one a day for twelve weeks.

Outcome(s)

Primary OutcomeCognitrax basic ver. (Verbal Memory, Visual Memory, Finger Tapping, Symbol Digit Coding, Stroop Test, Shifting Attention, Continuous Performance)
Secondary OutcomeJapanese version of the trail making test

Key inclusion & exclusion criteria

Age minimum55years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteria(1) Volunteers who take steadily (not less than three times a week) in the health-specific/functional/supplementary/health foods, which might affect the test results. (2) Volunteers who have taken affecting medicines (e.g., antibiotic/gut/laxative regulation), and have any difficulty in refraining from taking them during this study. (3) Volunteers being under medical treatment for dyslipidemia, after diagnosis. (4) Volunteers being under medical treatment for dementia, after diagnosis. (5) Volunteers who take excessive alcohol. (6) Volunteers having extremely irregular eating habits, and irregular life rhythms. (7) Volunteers who have a habit of daily vigorous exercises. (8) Volunteers who take not less than fourteen eggs in their daily life. (9) Volunteers who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases. (10) Pregnant, possibly pregnant, and lactating women. (11) Volunteers having drug and/or food allergy (especially to egg and wheat). (12) Volunteers who are now under another clinical test with some kind of medicine and/or health food, or took part in that within four weeks before this study, or will participate in that after giving informed consent to take part in this study. (13) Volunteers who donated their blood components and/or whole blood (200 mL) within a month to this trial. (14) Volunteers who donated their whole blood (400 mL) within the last three months to this trial. (15) Volunteers who will be collected in total of their blood (1200 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this study. (16) Others who have been determined as ineligible for participation, according to the principal investigator's opinion.

Related Information

Contact

public contact
Name Masanori Numa
Address 4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan Japan 101-0047
Telephone 03-5297-3112
E-mail cpcc-contact@cpcc.co.jp
Affiliation CPCC Company Limited Clinical Planning Department
scientific contact
Name Shukuko Ebihara
Address 2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan Japan
Telephone 03-5297-5548
E-mail cpcc-contact@cpcc.co.jp
Affiliation Chiyoda Paramedical Care Clinic Director