JPRN-UMIN000031975已完成未知
Effect of Daily Ingestion of High-Lycopene Tomato "PR-7" on Lipid Metabolism for 12 weeks: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study - Beneficial Effects of High-Lycopene Tomato "PR-7" on Lipid Metabolism
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 30years-old 至 70years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Subject who participated in the pilot study. 2. Subjects who usually do not intake raw tomatoes. 3. Subjects who usually intake tomato juice. 4. Subjects who are under physician's advice, treatment, and/or medication for dyslipidemia and/or diabetes. 5. Subjects whose BMI is >=30 kg/m2. 6. Subjects with familial hypercholesterolemia. 7. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 8. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 9. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 10. Subjects with severe anemia. 11. Pre- or post-menopausal women complaining of obvious physical changes. 12. Subjects who are at risk of having allergic reactions to drugs or foods especially based on tomato, Japanese cedar, Japanese cypress, or grass. 13. Subjects who regularly take medicine, functional foods, and/or supplements which would affect blood lipid levels. 14. Subjects who regularly take medicine, functional foods, and/or supplements which would affect glucose metabolism. 15. Alcohol addicts or subjects with eating disordered lifestyle. 16. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the current study. 17. Pregnant or lactating women or women who expect to be pregnant during this study. 18. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study. 19. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
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