Tokyo, July 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000055079) titled 'Trial to Evaluate the Impact of Single Dose Consumption of the Test Food on Psychological Effects' on July 26.
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. Men and women aged 20 to below 35 years at the time of consent acquisition.
2. Subjects with a Body Mass Index (BMI) less than 30.0 kg/m2.
3. Non-smokers (no smoking in the past year).
4. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria - 1. Subjects unable to adhere to the trial protocol during the study period.
2. Subjects consuming Food for Specified Health Uses (FOSHU), Foods with Function Claims, or health supplements (including supplements) that affect the autonomic nervous system, metabolism, and sleep, and cannot discontinue use during the study period.
3. Subjects taking medications or quasi-drugs that affect the autonomic nervous system, metabolism, and sleep, and cannot discontinue use during the study period.
4. Subjects who are participating in the other clinical trials and/or who have participated in the other clinical trials within 4 weeks prior to the current trial and/or who are planning to participate in the other clinical trials at the time of consent acquisition.
5. Subjects who have experienced significant life changes such as moving, changing jobs, or separation from close relatives within the last three months prior to consent acquisition, which could lead to high stress, or those likely to experience such events during the study period.
6. Subjects with irregular life rhythms (including those with highly irregular meal times, shift workers, night workers, etc.).
7. Subjects who engage in excessive physical exercise routinely.
8. Subjects with excessive alcohol intake.
9. Subjects who are physiologically unable to consume alcohol.
10. Subjects with severe symptoms of Premenstrual Syndrome (PMS).
11. Subjects with a current or past history of drug or alcohol dependence.
12. Subjects with allergic rhinitis that may interfere with trial operations.
13. Subjects under medical supervision for dietary or exercise therapy.
14. Subjects currently receiving treatment for, or with a history of, mental disorders (such as depression) or sleep disorders.
Target Size - 60
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2024 Year 06 Month 17 Day
Date of IRB - 2024 Year 06 Month 14 Day
Anticipated trial start date - 2024 Year 07 Month 28 Day
Last follow-up date - 2024 Year 09 Month 17 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062460
Disclaimer: Curated by HT Syndication.
