Tokyo, July 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058384) titled 'Functionality verification test by continuous intake of test food' on July 8.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Japan Clinical Trial Association

Condition: Condition - Healthy adult Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Verify the functionality of the test food after 12 weeks of continuous consumption Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Continuous intake of one packet per day of the test food for 12 weeks. Interventions/Control_2 - Continuous intake of one packet per day of the placebo for 12 weeks.

Eligibility: Age-lower limit - 40 years-old = Gender - Male and Female Key inclusion criteria - 1.Males and females aged of 40-59 years 2.Subjects who often feel tired in their daily lives and those who feel easily fatigued. 3.Subjects who feel that they catch colds easily or get sick easily. 4.Subjects who are able to maintain the daily routine they had before participating in this test. 5.Have obtained written consent to participate in this study of their own free will, based on a thorough understanding of the study. Key exclusion criteria - 1. Subjects who are currently receiving medical treatment or rprescription medication for chronic fatigue or chronic fatigue syndrome. 2. Subjects with a serious disease. 3. Pregnant, lactating, or planning to become pregnant during the study period 4. Subjects who are receiving medical treatment (hormone replacement therapy, drug therapy, exercise therapy, diet therapy, etc.) under the supervision of a physician 5. Subjects who are taking or have taken supplements, functional foods, or medicines that affect the immune system 6. Subjects who take or will take new supplements, functional foods, or medicines that affect immunity, sleep, body fat, or skin during the study period. 7. Subjects with food allergies. 8. Subjects with a history of drug dependence 9. Excessive smokers and excessive alcohol users 10. BMI less than 18.5 or more than 31 11. Subjects who plan to receive any vaccination from 30 days prior to the start of the study through the end of the study period. 12. Subjects who work night shift or rotating day and night shifts. 13. Subjects who have participated in other clinical trials within the past month and those who are scheduled to participate during the study period. 14. Subjects who are deemed inappropriate by the principal investigator. Target Size - 70

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 06 Month 03 Day Date of IRB - 2025 Year 06 Month 12 Day Anticipated trial start date - 2025 Year 07 Month 08 Day Last follow-up date - 2025 Year 10 Month 03 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066749

Disclaimer: Curated by HT Syndication.