Unique ID issued by UMIN | UMIN000041636 |
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Receipt number | R000047518 |
Scientific Title | Examination of the effect of cacao intake on performance and brain activity during cognitive task: single blind - investigators and assessors blind - cross over comparison study |
Date of disclosure of the study information | 2020/10/13 |
Last modified on | 2022/11/21 13:03:21 |
Examination of the effect of cacao intake on performance and brain activity during cognitive task: single blind - investigators and assessors blind - cross over comparison study
Examination of the effect of cacao intake on performance and brain activity during cognitive task
Examination of the effect of cacao intake on performance and brain activity during cognitive task: single blind - investigators and assessors blind - cross over comparison study
Examination of the effect of cacao intake on performance and brain activity during cognitive task
Japan |
Healthy adults
Adult |
Others
NO
To examine effects of single ingestion of cacao products on subjective feelings (fatigue, stress, boring, sleepiness, motivation, healng, joy, relax, and concentration), autonomic nervous function, cognitive function and brain function.
Efficacy
Comparison of brain activity during cognitive task at the period from 25 to 40 minutes after test food ingestion and from 50 to 65 minutes after test food ingestion.
Comparison of cognitive task performance at the period from 25 to 40 minutes after test food ingestion and from 50 to 65 minutes after test food ingestion.
Comparison of subjective feelings, measured by visual analog scale, before and after test food ingestion.
Comparison of autonomic nervous function before and after test food ingestion.
Interventional
Cross-over
Randomized
Individual
Single blind -investigator(s) and assessor(s) are blinded
Dose comparison
2
Treatment
Food |
Single ingestion of test food 1-> Washout (3 days or more) -> Single ingestion of test food 2
Single ingestion of test food 2-> Washout (3 days or more) -> Single ingestion of test food 1
30 | years-old | <= |
50 | years-old | > |
Male and Female
1) Individual who has received sufficient explanation about purpose and content of research, and consenting ability, and who volunteers with his/her free intent and gives written informed consent.
2) Healthy men and women aged 30 to under 50 at the time of informed consent.
- Individual who has been taken medications, quasi-drugs and supplements for more than 5 days a week within a month before screening test, or who plans to take those for more than 5 days a week during research period
- Individual who has a serious disease such as cranial nerve disease, liver disease, kidney disease, heart disease, cardiovascular disease, malignancy, or who has history of that
- Individual who has nervous seizure, color blindness, diabetes, or arrhythmia, or who has history of that
- Individual who has food allergy
- Individual who cannot intake foods containing a large amount of test food ingredients
- Individual who consume excessive alcohol
- Individual who has a smoking habit
- Individual who have day and night shift work and night work during research period
- Individual who quite poor performance for cognitive function task in the SCR
- Individual who did not complete the measurement of autonomic nervous system test in the SCR
- Individual who is left-handed
- Individual using internal or external life support devices
- Individual with a metallic foreign body inside
- Individual using orthodontic metal bridges
- Individual who is applying tattoos and permanent makeup
- Individual who is or has been engaged in the metalworking industry or in work that frequently handle metals
- Individual with mental attacks or claustrophobia
- Individual with impaired hearing, vocalization, or grip strength
- Individual who have difficulty in regulating body temperature regulation or sweating
- Individual who cannot continue supine for more than 1 hour
- Individual who has participated in other clinical research within a month before the research, or plan to participate that during the research period
- Individual who is pregnant, possibly pregnant, or breastfeeding, or who has plan or wish for pregnancy during the study period
- Individual whom principal investigator or sub-investigator judged to be inappropriate as a subject.
30
1st name | Akihiro |
Middle name | |
Last name | Sasaki |
RIKEN Center for Biosystems Dynamics Research
Laboratory for Pathophysiological and Health Science
650-0047
6-7-1, Minatojimaminami-machi, Chuo-ku, Kobe, Hyogo 650-0047, Japan
+81-78-569-8868
akihiro.sasaki@riken.jp
1st name | Akihiro |
Middle name | |
Last name | Sasaki |
RIKEN Center for Biosystems Dynamics Research
Laboratory for Pathophysiological and Health Science
650-0047
6-7-1, Minatojimaminami-machi, Chuo-ku, Kobe, Hyogo 650-0047, Japan
+81-78-569-8868
akihiro.sasaki@riken.jp
RIKEN
Meiji Co., Ltd.
Profit organization
RIKEN Kobe Institute Safety Center
2-2-3 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo 650-0047, Japan
078-306-3036
kobe-ankan@ml.riken.jp
NO
2020 | Year | 10 | Month | 13 | Day |
Unpublished
Completed
2020 | Year | 06 | Month | 17 | Day |
2020 | Year | 07 | Month | 31 | Day |
2020 | Year | 08 | Month | 28 | Day |
2021 | Year | 04 | Month | 30 | Day |
2020 | Year | 09 | Month | 01 | Day |
2022 | Year | 11 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047518
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