Tokyo, Sept. 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000055810) titled 'Validation study of test food effects on brain activity' on Sept. 17.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Morinaga & Co., Ltd.
Condition:
Condition - Healthy subjects
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To verify the effects of test food on brain activity.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Single ingestion of the test food > Washout period > Single ingestion of the placebo food
Interventions/Control_2 - Single ingestion of the placebo food > Washout period > Single ingestion of the test food
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - (1)Healthy male/female subjects ranging in age from 18 to 39, at informed consent.
(2)Subjects who can give informed consent to participate in this trial, after being provided with an explanation of the protocol detail.
(3)Subjects who can visit the designated measurement days and receive the measurement.
Key exclusion criteria - Subjects
1) who have a habit of continuously taking drugs, foods with health claims (Foods with Nutritional Function Claims, Foods for Specified Health Uses, and Foods with Function Claims), health foods, or supplements that claim to maintain or promote cognitive function (At least 3 times/week for at least 1 month), currently or within the past 3 months, or those who plan to take them during the study period
2) whose sleeping timeframe fluctuate greatly, such as shift work
3) who may change their lifestyle habits during the study period (Changing jobs, moving, long trips, learning, etc.)
4) being under another clinical test with medicine or health food, or partook in that within the past 4 weeks, or will partake in another clinical test
5) who may take medicine during the study period due to seasonal allergies (e.g., hay fever)
6) having a habit of smoking
7) with excessive alcohol intake
8) with lifestyle diseases (e.g., diabetes mellitus, hypertension, dyslipidemia) or diagnosed in the past
9) who has been diagnosed as having hyperglycemia through a medical examination
10) with neurological disorders such as dementia, stroke, Parkinson's disease, epilepsy, etc. (Excluding headaches and migraines)
11) who received medication for 1 month prior to obtaining consent or who plan to receive medication during the study period (Excluding history of taking medicine for headache, menstrual pain, cold, etc.)
12) with a past or current history of serious diseases (e.g., heart disease, cancer, renal failure)
13) who are pregnant, lactating or planning to become a pregnant during the study period
14) with sensitive skin to any coatings (e.g., drugs, quasi drugs, cosmetics), bath salts, tapes, etc., and those with wounds on the head (forehead, near mastoid process (behind ear))
15) with allergies to drug and/or food (including a history of these allergies) (especially milk and gelatin)
16) deemed unsuitable for participation in the trial by the principal investigator
Target Size - 14
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2024 Year 09 Month 24 Day
Date of IRB - 2024 Year 09 Month 20 Day
Anticipated trial start date - 2024 Year 12 Month 02 Day
Last follow-up date - 2024 Year 12 Month 09 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063787
Disclaimer: Curated by HT Syndication.
