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Double-Blind, Placebo-Controlled Study for the Effect of Lyophilized Herring-Roe Powder on Lipid Metabolism Improvement

Phase 3
Conditions
Healthy subjects
Registration Number
JPRN-UMIN000017072
Lead Sponsor
Hokkaido Information University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
32
Inclusion Criteria

Not provided

Exclusion Criteria

1.Subjects who are under treatment and medication for chronic ailments (especially diseases related to cancer, liver, kidney, heart, digestive system, diabetes, dyslipidemia, hypertension, mental disorder, etc.) 2.Subjects with serious cerebrovascular, cardiac, hepatic, renal and / or gastrointestinal diseases, or affected with an infectious disease which is required to report to the authorities 3. Subjects who have a major surgical history related to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 4. Subjects with familial hypercholesterolemia. 5. Subjects with frequent complaints of pre- or post-menopausal symptoms 6. Subjects with unusually high and/or low blood pressure, or with abnormal hematological data 7. Subjects with serious anemia 8. Subjects who are at risk of having allergic reactions to drugs or foods (especially fish-roe, soybean) 9. Subjects who take regularly thyroid drugs, or drugs containing EPA, statin, fibrate, ezetibime and/or steroids, etc. Or functional foods and/or supplements (EPA, DHA, MCT, phytosterol, sesamin, turmeric, polyphenols, dietary fiber, etc.) which would affect the blood lipids. 10. Heavy smokers, alcohol addicts or subjects with irregular lifestyle 11. Subjects who donate either 400ml whole blood within 12 weeks or 200ml within 4 weeks, or blood component within 2 weeks prior to this study 12. Subjects who are pregnant or expected to be pregnant, or lactating during the study 13. Subjects who participate in other clinical trials within the last one month prior to the current clinical trial 14. Any other medical reasons judged by the principal investigator

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
DL-Cho
Secondary Outcome Measures
NameTimeMethod
T-Cho,HDL-Cho,TG,RLP-Cho,NEFA, Adiponectin, Leptin, Fasting blood glucose, HbA1c, Body weight, BMI, Body fat rate, OSA sleep inventory, AIS
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