Study of reducing of serum LDL-cholesterol levels by ingestion of test supplement -A randomized, double blinded, placebo controlled, parallel group comparison study-

Study of reducing of serum LDL-cholesterol levels by ingestion of test supplement -A randomized, double blinded, placebo controlled, parallel group comparison study- - Study of reducing of serum LDL-cholesterol levels by ingestion of test supplement

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000043559

Enrollment

Registered

2021-03-12

Start date

2021-03-20

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

Intake of test supplement for 12 consecutive weeks Intake of placebo for 12 consecutive weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female whose age is between 20 and 65 years old. 2. Subjects whose serum LDL-cholesterol levels are between 120 mg/dl and 140 mg/dL at the baseline test.

Exclusion criteria

Exclusion criteria: 1. Subjects who routinely use pharmaceuticals, FOSHU, food with function claim, or health foods that affect serum lipid levels or lipid metabolism. 2. Subjects whose fasting serum triglyceride level are higher than 400 mg/dL at screening test. 3. Subjects who routinely use large amount of functional ingredients contained in test supplements 4. Subjects with a disease under treatment or with a history of serious disease that required medication. 5. Subjects who have or have had a serious disease such as diabetes, liver disease, kidney disease, or heart disease. 6. Subjects who are unable to perform the test according the prescribed procedure (e.g., enter web questionnaires, and web diary, fill out dietary records). 7. Subjects who are judged to be unsuitable to participate in the study based on answers of background survey. 8. Subjects who have allergy related to this study. 9. Subjects whose clinical laboratory tests, blood pressure, and physical measurements before intake of trial supplements are significantly out of the standard values. 10. Subjects who have participated in other clinical studies. 11. Subjects who intend to become pregnant or lactating. 12. Subjects judged as unsuitable for the study by the investigator for other reasons.

Design outcomes

Primary

Measure	Time frame
LDL-cholesterol level (Friedewald Equation)	—

Secondary

Measure	Time frame
Total cholesterol level, non-HDL cholesterol level, HDL-cholesterol level, triglyceride level, ratio of LDL-cholesterol and HDL-cholesterol, subgroup analysis	—

Countries

Japan

Contacts

Public ContactTakashi Nakagawa

EP Mediate Co., Ltd. Development Business Headquarters, TTC Center, Trial Planning Department

nakagawa768@eps.co.jp03-5657-4983

Outcome results

None listed

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