Effects of consumption of the test food on low density lipoprotein (LDL) cholesterol in healthy Japanese

Effects of consumption of the test food on LDL cholesterol in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study - Effects of consumption of the test food on LDL cholesterol in healthy Japanese

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000052633

Enrollment

Registered

2023-10-27

Start date

2023-10-27

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 Japanese

Interventions

Duration: Eight weeks Test food: Active food Duration: Eight weeks Test food: Placebo food

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals whose value of LDL cholesterol is close to 139 mg/dL at screening (before consumption) among those who meet inclusion criteria No.1~4 without meeting any of exclusion criteria

Exclusion criteria

Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking medications (including herbal medicines) and supplements 6. Individuals who are allergic to medicines and/or the test food related products 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study 9. Individuals who are judged as ineligible to participate in this study by the physician

Design outcomes

Primary

Measure	Time frame
1. The measured value of LDL cholesterol (Friedewald method) at eight weeks after consumption (8w)	—

Secondary

Measure	Time frame
1. The amount and rate of change of LDL cholesterol (Friedewald method) between screening (before consumption; Scr) and 8w 2. The measured values of LDL cholesterol (direct measurement), total cholesterol, high density lipoprotein (HDL) cholesterol, the ratio of LDL cholesterol per HDL cholesterol, and small dense LDL cholesterol at 8w, and the amount and rate of changes of them from Scr	—

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

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