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The verification study for blood lipid reduction effects : a randomized double-blind, parallel-group, placebo-controlled study

The verification study for blood lipid reduction effects : a randomized double-blind, parallel-group, placebo-controlled study - The verification study for blood lipid reduction effects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000027024
Enrollment
20
Registered
2017-09-30
Start date
2017-04-19
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

Duration: 12 weeks Test material: gamma-Tocotrienol cupsule Dose: Take one capsule, once a day Administration: Take one capsule after dinner Duration: 12 weeks Test material: Placebo Dose: Take

Sponsors

ORYZA OIL & FAT CHEMICAL CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy Japanese adults of 20 years old or more 2. LDL-cholesterol levels more than 120 mg/dL

Exclusion criteria

Exclusion criteria: 1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, or other chronic diseases 3. Currently taking medicines and/or herbal medicines 4. Those who eat Food with Functional Claims of the LDL-cholesterol reduction effects on a daily basis 5. Those who eat and/or drink Food for Specified Health Uses and/or Food with Function Claims on a daily basis 6. Allergic to medicines or foods related to the test food of this trial 7. Pregnant, lactating, or planning to get pregnant during the trial period 8. Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial 9. Judged unsuitable for participating in this trial by physician

Design outcomes

Primary

MeasureTime frame
LDL-cholesterol at 12 weeks after the ingestion

Secondary

MeasureTime frame
1. Total cholesterol, HDL-cholesterol, LDL/HDL ratio, triglyceride (TG) 2. Body weight

Countries

Japan

Contacts

Public ContactNorihito Shimizu

ORYZA OIL & FAT CHEMICAL CO., LTD. Food Development Dept. R & D Center

kaihatsu@mri.biglobe.ne.jp0586865141

Outcome results

None listed

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