Study on the Efficacy of Continuous Intake of Test Food on Liver Function - A Placebo-Controlled Randomized Double-Blind Parallel Group Comparison Trial

UMIN ID: UMIN000054026

Registered date:05/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy adults
• Date of first enrollment: 2024/06/14
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

The test food will be consumed once a day for 24 weeks, two tablets each time, after breakfast, without chewing, with water or lukewarm water.
The placebo food will be consumed once a day for 24 weeks, two tablets each time, after breakfast, without chewing, with water or lukewarm water.

Outcome(s)

• Primary Outcome: Blood ALT level at 24 weeks of intake
• Secondary Outcome: Blood ALT levels at 6, 12, and 18 weeks of intake Blood AST levels at 6, 12, 18, and 24 weeks of intake Blood gamma-GTP levels at 6, 12, 18, and 24 weeks of intake Liver fat content (FibroScan CAP values) at 12 and 24 weeks of intake Liver fibrosis-related index at 24 weeks of intake Fatty liver-related index at 6, 12, 18, and 24 weeks of intake

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1. Those with FibroScan VCTE values of 6.0 kPa or more (indicating liver fibrosis). 2. Those currently on medical treatment (except as-needed medication). 3. Those under diet or exercise therapy supervision. 4. Those with a current severe disease. 5. Those regularly utilizing quasi-drugs, drugs, or health foods that may affect test items like obesity, hyperlipidemia, lipid metabolism, and liver function. 6. Those regularly using quasi-drugs, drugs (excluding as-needed medication), and health foods other than item 5 (can participate if able to quit from consent acquisition to trial end). 7. Those with a current or past history of serious liver diseases or suspected of such diseases. 8. Those with gastrointestinal surgery history (except appendicitis). 9. Those with cardiac pacemakers or implanted medical devices. 10. Those with excessive drinking habits (60 g or more for men, 40 g or more for women in pure alcohol conversion per day on a weekly average). 11. Those unable to abstain from alcohol the day before the visit. 12. Those with excessive smoking habits (21 or more cigarettes per day). 13. Those with excessive exercise habits (those aiming for personal best records in competitions). 14. Those with current food or drug allergies. 15. Those with current or past drug or alcohol addiction. 16. Those with night shifts due to shift work. 17. Those planning significant lifestyle changes (diet, sleep, exercise, etc.) during the study period. 18. Those planning to travel overseas during the study period. 19. Those who tested positive for infectious diseases at SCR visit. 20. Those participating in other clinical trials or have participated within one month of the trial end. 21. Those who have had blood drawn more than 200 mL within a month, or more than 400 mL within three months prior to the study period. 22. Pregnant, lactating, or women wishing to become pregnant during the study period. 23. Those deemed unsuitable by the principal investigator, etc.

Related Information

• Primary Sponsor: IMEQRD Co., Ltd
• Source(s) of Monetary Support: EN Otsuka Pharmaceutical Co., Ltd.