Exploratory study on effect of cacao intake on human brain function: single blind - investigators and assessors blind - cross over comparison study.

Not Applicable

• Conditions: Healthy adults

• Registration Number: JPRN-UMIN000036746
• Lead Sponsor: RIKE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-06-27
• Study Start: 2020-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Individual who has been taken medications, quasi-drugs (excluding topical 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. (2) 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. (3) Individual who has nervous seizure (such as Loss of consciousness, coma, convulsions), color blindness, diabetes, or arrhythmia, or who has history of that. (4) Individual who has dysfunction of autonomic nervous system (whose value of LF/HF is more than 10 on the screening test). (5) Individual who has food allergy (6) Individual who can not intake bitter chocolate (dark chocolate) (*1) (7) Individual who consume excessive alcohol (average of 60 g/day or more in alcohol equivalent) (8) Individual who has a smoking habit (9) Individual who have day and night shift work and night work (10) Individual has poor performance, less than 50% correct answer rate) in the cognitive function task (confirmation of answer ability) at the screening test. (11) Individual who has participated in other clinical research within a month before the research, or plan to participate that during the study period. (12) Individual who is pregnant, possibly pregnant, or breastfeeding, or who has plan or wish for pregnancy during the study period. (13) Individual whom principal investigator or sub-investigator judged to be inappropriate as a subject. *1. Bitter (or dark) chocolate refers to chocolate with 40-60 % cacao mass containing no milk (or milk component), chocolate with low sugar or milk content and high bitterness, and chocolate with 70-90% cacao content and low sugar.

Study & Design

• Study Type: Interventional
• Study Design: Not specified