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A Study on the Effect of Food Containing Plant Extract on Liver Function -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-

A Study on the Effect of Food Containing Plant Extract on Liver Function -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study- - A Study on the Effect of Food Containing Plant Extract on Liver Function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000047438
Enrollment
60
Registered
2022-04-08
Start date
2022-04-09
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

None listed

Interventions

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Healthy males and females aged 20 to 64 years old. (2)Subjects whose AST and ALT are up to 50 U/L, and gamma-GTP are up to 100 U/L in the screening test. (3)Subjects whose BMI are less than 30. (4)Subjects who are judged not suffering from a disease by the investigator. (5)Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

Exclusion criteria: (1)Subjects who regularly use medications. (2) Subjects who contract or are under treatment for serious diseases (e.g., liver disease, cardiovascular disease, respiratory disease, endocrine disease and/or metabolic disease). (3)Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption. (4) Subjects who have a history of and/or contract drug addiction and/or alcoholism. (5)Subjects who have excessive alcohol intake more than approximately 60 g/day of pure alcohol equivalent or habit of drinking not less than 5 days a week. (6)Subjects who can't stop using supplements and/or functional foods (including Foods with Function Claims) during test periods. (7)Subjects who can't stop drinking from 2 days before each measurement. (8)Subjects who have declared allergic reaction to ingredients of test foods. (9)Subjects who are shiftworker and/or midnight-shift worker. (10)Subjects with extremely irregular dietary habits. (11)Subjects who plan to travel abroad, including overseas travel, during test periods. (12)Subjects who have been pregnant or have a plan to become pregnant, or breast feed during the study period. (13)Subjects who have donated over 200 mL of blood and/or blood components within the last 4 weeks prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study. (14)Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study. (15)Subjects who are judged as unsuitable for the current study by the investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
Liver function enzyme

Secondary

MeasureTime frame
Questionnaire survey (Visual Analogue Scale)

Countries

Japan

Contacts

Public ContactYoshika Komori

KSO Corporation Sales department

eigyou27@kso.co.jp03-3452-7733

Outcome results

None listed

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