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Effect of 12-week continuous ingestion of the supplement on liver function.-A placebo-controlled, randomized, double-blind, parallel-group comparative study-

Effect of 12-week continuous ingestion of the supplement on liver function.-A placebo-controlled, randomized, double-blind, parallel-group comparative study- - Effect of 12-week continuous ingestion of the supplement on liver function.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000044495
Enrollment
100
Registered
2021-06-11
Start date
2021-06-12
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 adults

Interventions

Test food(Intake period:12 weeks) Control food (Intake period:12 weeks)

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Male and female aged between 20 to 64 years old at the time of informed consent. 2.Subjects whose BMI is between the range of 25 and 29 kg/m2. 3.Subjects whose ALT is between 31 to 50 U/+-10% at the time of the screening test 1. 4.Subjects whose ALT is between 31 to 50 U/L+-10% at the time of the screening test 2. 5.Subjects who agree to participate in the study on one's own will.

Exclusion criteria

Exclusion criteria: 1.Subjects whose AST is above 50 U/L and/or Gamma-GTP above 100 U/L at the time of the screening test 2. 2.Subjects who have history of liver disease, or is currently under medical treatment of the liver disease. 3.Subjects who are suffering or suffered from serious disease in the past. 4.Subjects who have average intake of alcohol more than 59 g per week. 5.Subjects who have food allergies or who may be allergic to the test food. 6.Subjects who are taking drugs and quasi-drugs that may affect the current study. 7.Subjects who are taking health foods that may affect the current study. 8.Subjects who cannot stop taking the drugs, quasi-drugs and health foods during the study period (after agreeing to the informed consent until the end of the 12-week test food ingestion period). 9.Subjects who have extremely irregular lifestyles. 10.Subjects who are currently participating in other studies, or participating in other studies within the past 3 months from the time of the informed consent. 11.Subjects who are planning to participate in other studies during this study. 12.Subjects who are pregnant, or planning to become pregnant or breastfeed during this study. 13.Subjects who are judged as unsuitable participant for the study by the doctor and investigator.

Design outcomes

Primary

MeasureTime frame
ALT : Alanine Aminotransferase

Secondary

MeasureTime frame
AST : Aspartate Aminotransferase Gamma-GTP : Gamma-Glutamic Transpeptidase

Countries

Japan

Contacts

Public ContactEiji Yoshikawa

KSO Corporation Sales department

eigyou27@kso.co.jp03-3452-7733

Outcome results

None listed

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