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

Not Applicable
Conditions
Healthy adults
Registration Number
JPRN-UMIN000023894
Lead Sponsor
ORTHOMEDICO, Inc.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
14
Inclusion Criteria

Not provided

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. LDL-cholesterol *1 Take the blood samples at 0 week and 12 weeks after the ingestion
Secondary Outcome Measures
NameTimeMethod
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
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