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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023894
Enrollment
14
Registered
2016-09-01
Start date
2016-09-02
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: &quot
Administration: Drink it at any time of a day Duration: 12 weeks Test material: &quot
Placebo beverage&quot
Administration: Drink it at any time of a day

Sponsors

ORTHOMEDICO, Inc.
Lead Sponsor
Seishin-kai Medical Association Inc, Takara Medical Clinic.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy Japanese adults of 20 years old or more 2. LDL-cholesterol levels were higher in the boundary region at most recent medical check-up

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, hypertension 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 and drink beverage with related to vinegar 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
1. LDL-cholesterol *1 Take the blood samples at 0 week and 12 weeks after the ingestion

Secondary

MeasureTime frame
1. Total cholesterol, HDL-cholesterol, LDL/HDL ratio, triglyceride (TG), glucose, HbA1c, and glycoalbumin *1 Take the blood samples at 0 week and 12 weeks after the ingestion 2. Body weight, BMI, and body fat percentage *2 Take the measurements at 0 week and 12 weeks after the ingestion

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