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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000028838

Enrollment

Registered

2017-09-05

Start date

2017-08-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy subjects

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Subjects giving written informed consent 2. Age: 20 and over, below 65 Males and females with Japanese nationality who are not affected with a disease 3. Persons who are able to drink 1 can of beverage per day for 12 weeks on a continuous basis 4.As liver function markers, ALT: 50 and below, GAMMA-GTP: 100 and below, AST: 50 or below 5. LDL-C: 120 to 159 mg/dl 6.Average pure alcohol intake per day for males: below 60 g, females: below 40 g

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
1.ALT 2.LDL-C	—

Secondary

Measure	Time frame
1.GAMMA-GTP 2.AST 3.TC 4.HDL-C 5.TG	—

Countries

Japan

Contacts

Public ContactOchitani Daisuke

HUMA R&D CORP Clinical Development Division

ochitani@huma-c.co.jp81-3-3431-1260

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026