Verification test on improvement in a liver disorder marker and a cholesterol lowering effect

UMIN ID: UMIN000028838

Registered date:05/09/2017

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy subjects
• Date of first enrollment: 2017/08/30
• Target sample size: 69
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

12-week intake of the test food
12-week intake of the test food
12-week intake of the placebo food

Outcome(s)

• Primary Outcome: 1.ALT 2.LDL-C
• Secondary Outcome: 1.GAMMA-GTP 2.AST 3.TC 4.HDL-C 5.TG

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1. Currently in treatment with medication or seeing a doctor for treatment 2. Previous history of severe liver disorder (viral hepatitis, drug-induced liver injury, cirrhosis) or currently suspected to have liver disorder (a positive test result on hepatitis screening, etc.) 3. Previous history of liver disorder or severe disorder related to kidney, endocrine, cardiovascular system, gastrointestine, lung, blood, metabolism, or currently presence of complications 4. Previous history of a drug allergy and/or food allergy 5. Regular intake of a health food product or supplement possibly influencing the liver function and lowering cholesterol 6. Regular intake of medication possibly influencing the liver function and lowering cholesterol 7.Extreme faddiness 8. Extremely irregular lifestyle such as a dietary pattern and a sleeping pattern 9.Presence or previous history of mental disorder (depression, etc.) 10. A large volume of alcohol intake (average pure alcohol intake per day for males: 60 g or over, females: 40 g or over) 11.11) Current participation in another clinical trial or participation in another clinical trial within the last three months 12.Determined by the investigator to be unsuitable for enrollment in this study

Related Information

• Primary Sponsor: HUMA R&D CORP
• Source(s) of Monetary Support: Asahi Group Holdings,Ltd