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Effect of daily ingestion of the test drink on HDL-cholesterol level: A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Comparison Study

Effect of daily ingestion of the test drink on HDL-cholesterol level - Effect of daily ingestion of the test drink on HDL-cholesterol level

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000044228
Enrollment
270
Registered
2021-06-30
Start date
2021-07-01
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

Daily ingestion of 200 mL of juice containing active ingredient for 12 weeks Daily ingestion of 200 mL of juice not containing active ingredient for 12 weeks

Sponsors

Leverage Brain Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects who agree to participate in this study with a written informed consent 2. Subjects whose HDL-cholesterol level is >=35 mg/dL and <=60 mg/dL

Exclusion criteria

Exclusion criteria: 1. Subjects who are under physician's advice, treatment, and/or medication for dyslipidemia and/or diabetes. 2. Subjects with familial hypercholesterolemia. 3. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 4. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 5. Subjects who have had allergic reactions to drugs or foods especially based on test food, Japanese cedar, Japanese cypress, or grass. 6. Subjects who regularly use medicines, health foods, and supplements. 7. Subjects who regularly take foods containing ingredients of test food. 8. Heavy smokers. 9. Alcohol addicts. 10. Subjects with disordered lifestyle. 11. Subjects with anemia. 12. Pre- or post-menopausal women complaining of obvious physical changes. 13. Pregnant or lactating women, women who expect to be pregnant during this study or may be pregnant. 14. Subjects who currently participate in other clinical trials or participated within the last 4 weeks prior to the current study. 15. Subjects who regularly exercise. 16. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.

Design outcomes

Primary

MeasureTime frame
HDL-cholesterol level

Secondary

MeasureTime frame
Total cholesterol level, LDL-cholesterol level, triglyceride level, serum active ingredient level, skin carotenoid level

Countries

Japan

Contacts

Public ContactShigeru Imai

Leverage Brain Inc. Clinical Trial Department

imai@levbrain.com080-7290-0404

Outcome results

None listed

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