Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059256) titled 'Verification of the Effects of a Single Dose of a Test Food on Psychological Effects' on Oct. 1.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved 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 investigate the psychological changes induced by single dose consumption of the test food product.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Consumption of the test food
Interventions/Control_2 - Consumption of the placebo food
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1. Male and female aged 20 to below 40 years at the time of consent acquisition.
2. Individuals with a body mass index (BMI) of less than 30.0 kg/m2.
3. Individuals with no smoking history (for at least one year).
4. Individuals who are able to give informed consent to participate in this study after receiving a detailed explanation of the protocol and understanding its contents.
Key exclusion criteria - 1. Individuals who are unable to adhere to the trial protocol during the study period.
2. Individuals who are consuming Foods for Specified Health Uses, Foods with Function Claims, or health supplements (including supplements) that may affect the autonomic nervous system, metabolism, or sleep, and who cannot discontinue their use during the study period.
3. Individuals who are taking medications or quasi-drugs that may affect the autonomic nervous system, metabolism, or sleep, and who cannot discontinue their use during the study period.
4. Individuals who are participating in other clinical trials, who have participated in other clinical trials within 4 weeks prior to the current trial, or who plan to participate in other clinical trials at the time of consent acquisition.
5. Individuals who have experienced significant life changes (e.g., moving, changing jobs, or separation from close relatives) within 3 months prior to consent acquisition, which could lead to high stress, or those who are likely to experience such events during the study period.
6. Individuals with irregular lifestyles (including those with highly irregular meal times, shift workers, and night workers).
7. Individuals who routinely engage in excessive physical exercise.
8. Individuals with excessive alcohol intake.
9. Individuals who are physiologically unable to consume alcohol.
10. Individuals who dislike non-alcoholic beer, beer, or beer flavor.
11. Individuals who are unable to abstain from alcohol starting from the day before the trial.
12. Individuals with severe symptoms of premenstrual syndrome (PMS).
13. Individuals with a current or past history of drug or alcohol dependence.
14. Individuals with allergic rhinitis that may interfere with trial procedures.
15. Individuals who are under medical supervision for dietary or exercise therapy.
Target Size - 60
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2025 Year 09 Month 22 Day
Date of IRB - 2025 Year 09 Month 19 Day
Anticipated trial start date - 2025 Year 10 Month 02 Day
Last follow-up date - 2025 Year 12 Month 05 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067649
Disclaimer: Curated by HT Syndication.
