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The verification study of triglyceride level in blood suppression effects: a randomized, double-blind, parallel-group, placebo-controlled trial

The verification study of triglyceride level in blood suppression effects: a randomized, double-blind, parallel-group, placebo-controlled trial - The verification study of triglyceride level in blood suppression effects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000030110
Enrollment
20
Registered
2017-11-24
Start date
2017-11-25
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 adult people

Interventions

Duration: 8 weeks Active: Pure white sesame oil Administration: Eat 14 g/day of the active oil with the bread from the store or eat the oil directly at breakfast. * If you forget to eat the activ

Sponsors

ORTHOMEDICO Inc.
Lead Sponsor
Medical Corporation Seishinkai, Takara Clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy Japanese adult people with relatively higher level of blood triglyceride 2. Subjects who are judged as eligible to participate in the study by the principal investigator 3. Among the subjects who met 2nd inclusion criteria, preferentially select subjects whose blood triglyceride level is on the borderline (120 ~ 149 mg/dL), then select subjects whose blood triglyceride level is relatively higher (150 ~ 199 mg/dL). If the number of people who met 2nd inclusion criteria is less than the sample size, select subjects whose blood triglyceride level is relatively higher, however, less than 120 mg/dL.

Exclusion criteria

Exclusion criteria: 1. At least one previous medical history or under the treatment 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, hypertension, or other chronic diseases 3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional foods/beverages in daily 4. Currently taking medicines (include herbal medicines) and supplements 5. Subjects who are allergic to medicines and/or the test food related products *Particularly, sesame and soybean allergies 6. Subjects who are pregnant, breast-feeding, and planning to become pregnant 7. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 8. Subjects who are judged as ineligible to participate in the study by the principal investigator

Design outcomes

Primary

MeasureTime frame
Triglyceride * Assess at screening and examination before consuming and at 4 and 8 weeks after consuming

Secondary

MeasureTime frame
1. Total cholesterol 2. High-density lipoprotein (HDL) cholesterol 3. Low-density lipoprotein (LDL) cholesterol * Assess at screening and examination before consuming and at 4 and 8 weeks after consuming

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