Unique ID issued by UMIN | UMIN000046600 |
---|---|
Receipt number | R000052960 |
Scientific Title | Effects of breakfast on cognitive functions |
Date of disclosure of the study information | 2022/01/13 |
Last modified on | 2022/07/22 10:46:28 |
Effects of breakfast on cognitive functions
Effects of breakfast on cognitive functions
Effects of breakfast on cognitive functions
Effects of breakfast on cognitive functions
Japan |
No
Not applicable | Adult |
Others
NO
This study aims at elucidating the effects of breakfast with the test food on cognitive functions, operating efficacies, and sensory scales
Efficacy
[1] Cognitive function test (1)
[2] Work efficiency inspection (1)
[3] Questionnaire survey on sensation (1)
(1): Screening,Before and after ingestion of the test food. [observation period I and II]
*Secondary indexes
[1] Blood pressure,pulsation (Screening, Before ingestion of the test food. [observation period I and II]).
[2] Subject's diary (From the first day of ingestion of a test material to the last day of the test).
[3] Doctor's questions (Screening, After ingestion of the test food. [observation period I and II]).
*Other indexes
[1] Baseline characteristics (Screening).
[2] Weight,body fat percentage,BMI (Screening).
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
[1]Oral ingestion of a test food (1 time).
[2]Observation.
[3]Washout (over 3days)
[4]Oral ingestion of a Control food. (1 time).
[5]Observation.
[1]Oral ingestion of a Control food (1 time).
[2]Observation.
[3]Washout (over 3days)
[4]Oral ingestion of a test food. (1 time).
[5]Observation.
30 | years-old | <= |
50 | years-old | > |
Male and Female
[1] Males and females aged 30-49 years.
[2] Individuals who are healthy and are not suffered from a chronic malady including skin disease.
[3] Individuals whose written informed consent has been obtained.
[4] Individuals judged appropriate for the study by the principal.
[1] Individuals using medical products.
[2] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[3] Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
[4] Individuals who are a patient or have a history of or endocrine disease.
[5] Individuals with or under treatment for memory impairment such as dementia
[6] Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis).
[7] Individuals whose BMI is over 25kg/m2.
[8] Individuals who do not have the habit of eating breakfast and those who have irregular eating habits.
[9] Individuals who are sensitive to the test food.
[10] Individuals who are not good ingesting caffeine-containing foods such as coffee.
[11] Individuals who are a smoker.
[12] Individuals who habitually take the foods for specified health uses (FOSHU) or functional food (except for subjects who can stop consume them after informed consent).
[13] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day).
[14] Individuals with possible changes of life style, such as conducting a long-term travel, during the test period.
[15] Individuals who are or are possibly pregnant, or are lactating.
[16] Individuals who participated in other clinical studies in the past 3 months.
[17] Individuals who are or whose family is engaged in functional foods or cosmetics.
[18] Individuals judged inappropriate for the study by the principal.
20
1st name | Takahiro |
Middle name | |
Last name | Ono |
Ueno-Asagao Clinic
Head
110-0015
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
+81-3-6240-1162
info@ueno-asagao.clinc
1st name | Ryoma |
Middle name | |
Last name | Shimizu |
TES Holdings Co., Ltd.
Administrative Department of Clinical Trials
110-0015
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
+81-3-6801-8480
r.shimizu@tes-h.co.jp
TES Holdings Co., Ltd.
Nestle Japan Ltd.
Profit organization
Ueno-Asagao Clinic Ethical Review Committee
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
+81-3-6240-1162
i.takahashi@tes-h.co.jp
NO
2022 | Year | 01 | Month | 13 | Day |
Unpublished
Completed
2021 | Year | 12 | Month | 15 | Day |
2021 | Year | 12 | Month | 16 | Day |
2022 | Year | 01 | Month | 19 | Day |
2022 | Year | 01 | Month | 28 | Day |
2022 | Year | 01 | Month | 11 | Day |
2022 | Year | 07 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052960
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |