Tokyo, Nov. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059773) titled 'A Study on the Effects of Continuous Intake of a Food Product on Physical and Mental Health' on Nov. 14.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - CPCC Company Limited
Condition:
Condition - Healthy adult male
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To confirm the effects of continuous intake of the test food on physical and mental health.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Oral consumption of the test food (4 pieces per time, twice daily) for 4 weeks
Eligibility:
Age-lower limit - 30
years-old
Gender - Male
Key inclusion criteria - 1. Healthy males aged 30 to below 40 years at the time of consent acquisition.
2. Individuals with a body mass index (BMI) of 18.5 kg/m2 or higher and less than 25.0 kg/m2.
3. Individuals who constantly perceive daily stress.
4. Individuals who spend 30 minutes or more outdoors during the day (e.g., during commuting) without sunglasses.
5. 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 regularly consume Foods for Specified Health Uses, Foods with Function Claims, or health foods (including supplements) that may affect the study (including sleep improvement and stress reduction claims) and are unable to discontinue use from one month before the pre-examination and test food intake.
2. Individuals who take medications (e.g., antibiotics, laxatives, gastrointestinal drugs) that may affect the study and who cannot restrict their use during the study period.
3. Individuals who are receiving medical care or drug treatment for a disease that may affect the study.
4. Individuals diagnosed with severe anemia based on pre-examination blood test results.
5. Individuals with a habit of consuming foods/beverages containing cacao, cocoa, or cocoa butter (once a week or more).
6. Individuals who dislike chocolate.
7. Individuals with bruises or scars on the skin measurement area (inner side of the left forearm).
8. Individuals who are participating in, have participated in within the four weeks prior to the current trial, or are planning to participate in clinical trials of pharmaceuticals or health foods.
9. Individuals with extremely irregular lifestyles (such as night shifts, irregular shift work, or irregular sleep habits).
10. Individuals with excessive alcohol intake.
11. Individuals who are in the habit of smoking, or have been in the habit of smoking within the past six months.
12. Individuals who, at the time of consent acquisition, have plans involving significant changes in lifestyle or sleep habits (e.g., overseas business trips of 2 weeks or longer) during the study period.
13. Individuals who will develop hay fever symptoms during the study period, or who plan to take medication during the same period.
14. Individuals with previous and/or current medical history of serious diseases in the heart, liver, kidney, digestive organs, etc., (including perioperative period).
Target Size - 24
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 29 Day
Date of IRB - 2025 Year 10 Month 24 Day
Anticipated trial start date - 2025 Year 11 Month 17 Day
Last follow-up date - 2026 Year 03 Month 26 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067801
Disclaimer: Curated by HT Syndication.
