A PILOT STUDY ON TREATMENT EFFECT OF TOMATO LYCOPENE AND SOY ISOFLAVONES ON

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 番茄红素衍生物还被证明可以提高细胞培养中的胰岛素敏感性，并改善2型糖尿病动物模型以及肥胖和瘦削的Zucker大鼠的胰岛素抵抗。关于口服番茄红素对人类外周胰岛素敏感性的影响的数据仍不清楚。我们假设番茄红素和/或大豆异黄酮可以提高胰岛素的降血糖能力。本研究的目的是测量含有番茄红素、大豆异黄酮片或两者组合的片剂治疗12周对胰岛素降血糖能力的影响。我们将邀请健康的志愿者参与这项研究。每个志愿者都测量了皮褶，以估计体内的脂肪含量。入院期间还将测量体重和身高。早上，在隔夜禁食后，每个志愿者都将接受一项名为正常血糖-高胰岛素钳夹的测试。这项测试可以测量胰岛素在降低血糖方面的效果。然后，我们会给志愿者一颗含有番茄红素、异黄酮类成分的胶囊，或两种不同的含有番茄红素和异黄酮类成分的胶囊(未预先混合)。在12周结束时，每个志愿者将再次接受首次入院时所做的相同测试。如果我们的研究证实番茄红素和/或大豆异黄酮可以改善胰岛素降低血糖的能力，这种治疗方法可以用于有风险或已经患上糖尿病的人。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Lycopene derivative has been also shown to increase insulin sensitivity in cell cultures and improve insulin resistance in animal models of type 2 diabetes and in obese and lean Zucker rats. Data about the effect of oral administration of lycopene on peripheral insulin sensitivity in human is still unknown. We hypothesize that Lycopene and/or soy isoflavones can improve the ability of insulin to lower blood sugar. The objective of this study is to measure the effect of 12 weeks treatment with tablets containing Tomato Lycopene, Soy Isoflavones or a combination of the two, on the ability of insulin to lower blood sugar. We will ask healthy volunteers to participate in this study. Each volunteer and have skinfolds measured to estimate content of fat in the body. Weight and height will also be measured during the admission. In the morning, after overnight fast, each volunteer will have a test called euglycemic-hyperinsulinemic clamp. This test allows measuring how well insulin works in decreasing blood sugar. We will then give the volunteer either a capsule that contains lycopene, isoflavone, a premix of the two or 2 different capsules with lycopene and isoflavones (not pre-mixed). At the end of 12 weeks each volunteer will again be given the same tests done on first admission. If our study confirms that tomato lycopene and/or soy isoflavones can improve the ability of insulin to lower blood sugar, this treatment could be used in persons who are at risk or who have already developed diabetes.