Tokyo, Sept. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059200) titled 'Verification of the Effects of a Single Dose of a Test Food on Brain Activity' on Sept. 26.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Single blind -investigator(s) and assessor(s) are blinded
Control - Placebo
Primary Sponsor:
Institute - CPCC Company Limited
Condition:
Condition - Male/female adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To verify some kind of effect on brain activity by the test-food intake in a single dose
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Consumption of the test liquid (200 mL) within 3 min.
Interventions/Control_2 - Consumption of the placebo liquid (200 mL) within 3 min.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1. Male/female ranging in age from 20 to 34 at informed consent.
2. Individuals having less than 25.0 kg/m2 of BMI.
3. Individuals with no smoking (not less than one year).
4. Individuals who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria - 1. Individuals being under some kind of continuous medical treatment, including the test period.
2. Individuals who have periodically used health-specific / functional / health foods including supplements, which might affect the autonomic nervous system, metabolism and sleep.
3. Individuals with incompatible chest (e.g., thick body hair, pacemaker-fitting) for heartbeat measurements.
4. Individuals with excessive alcohol intake.
5. Individuals with extremely irregular eating habits, and having an irregular life rhythm with irregular shift work or midnight one.
6. At the moment of informed consent, Individuals who are under the other clinical tests with some kind of medicine/food, or participated in those within four weeks after the current trial, or are planning to join those after the consent.
7. Individuals who are under a large stress condition with some kind of life event, such as house-moving, transfer, bereavement, etc., within three months before the agreement for this trial and during the test period.
8. Individuals with any difficulty in giving up drinking since the day before the scheduled date of this trial.
9. Individuals with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
10. Individuals getting excessive exercise every day.
11. Individuals with a serious symptom of premenstrual syndrome.
12. Individuals who dislike the flavor of test foods (such as the aroma of sake or the scent of apples, pears, pineapples, etc.)
13. Pregnant, possibly pregnant, and lactating women.
14. Individuals having some kind of drug and/or food allergy.
15. Individuals who break out in a rash from putting electrodes on the head and chest.
16. Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Target Size - 24
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 01 Day
Date of IRB - 2025 Year 08 Month 29 Day
Anticipated trial start date - 2025 Year 09 Month 29 Day
Last follow-up date - 2025 Year 11 Month 26 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066952
Disclaimer: Curated by HT Syndication.
