Effect of daily ingestion of Kishu plum ( Prunus mume) on arteriosclerosis and lipid metabolism: a double-blind, placebo-controlled, parallel group comparison study.
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000020201
- Lead Sponsor
- Hokkaido Information University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 52
Not provided
1. Subjects who are under treatmentand medication for hyperlipidemia and diabetes. 2. Subjects with familial hypercholesterolemia. 3. Subjects whose LDL-C is >=180 mg/dl. 4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, disorder of endocrine and metabolism or affected with infectious diseases which are required to report to the authorities. 5. Subjects who have a major surgical history related to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 6. Subjects with unusually high and/or low blood pressure or abnormal hematological data. 7. Subjects with serious anemia. 8. Pre- or post-menopausal women having obvious changes in physical condition. 9. Subjects who are at risk of having allergic reactions to drugs or foods (especially plum and agar). 10. Subjects who regularly take drugs, functional foods and/or supplements (EPA, DHA, MCT, phytosterol, sesamin, turmeric, polyphenols, dietary fiber, etc.) which would affect the blood lipid levels. 11. Subjects who regularly take drugs, functional foods and/or supplements (containing dietary fiber such as indigestible dextrin, polyphenol, etc.) which would affect blood glucose. 12. Heavy smokers, alcohol addicts or subjects with irregular lifestyle 13. Subjects who donate either 400ml whole blood within 12 weeks or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to this study. 14. Pregnant or lactating women or women expect to be pregnant during the clinical trial. 15. Subjects who participate in other clinical trials within the last one month prior to this study. 16. Any other medical reasons judged by the principal investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Arteriosclerosis Index, TC, LDL-C, HDL-C and TG at 4, 8 and 12 weeks after the beginning of ingestion of test meals.
- Secondary Outcome Measures
Name Time Method oxo-LDL, TBARS, VAS questionnaire for lassitude and defecation, frequency of bowel movement, body composition (BW, BFR, BMI)