Soy Almond Bread as Complimentary Therapy for Prostate Cancer

大豆杏仁面包作为前列腺癌的补充疗法

基本信息

批准号：
7646429
负责人：
Yael Vodovotz
金额：
$ 20.25万
依托单位：
OHIO STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-07-01 至 2011-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7646429
关键词：
Accounting Address Adjuvant Aging Almond Nut Alternative Therapies Androgens Animal Model Antioxidants Area Asians Bioavailable Biochemical Biological Biological Availability Biological Markers Blood Bread Breast Cancer Patient Cardiovascular system Cholesterol Clinical Clinical Trials Clinical Trials Design Coagulation Process Complementary therapies Consumption Cross-Over Studies Data Descriptive Epidemiology Diet Dietary Intervention Dietary Practices Dietary intake Disease Drug Kinetics Employee Strikes Enzymes Estrogens Excretory function Exhibits FDA approved Failure Figs - dietary Food Future Genetic Crossing Over Genistein Glucosides Goals Health Health Benefit Heart Hormonal Hormones Human Hydrolysis In Vitro Incidence Individual Insulin-Like Growth Factor Binding Protein 3 Insulin-Like Growth Factor I Intervention Intervention Trial Isoflavones Laboratories Laboratory Animal Models Lignans Liver Malignant Neoplasms Malignant neoplasm of prostate Marketing Measurable Disease Metabolism Monitor Nutritional Nutritionist Ohio Osteoporosis Outcome PSA Velocity Parents Patients Pattern Phase Phase III Clinical Trials Physicians Phytochemical Plasma Population Powder dose form Preventive Property Prostate Prostate Cancer therapy Proteins Publishing Randomized Randomized Clinical Trials Recommendation Records Renal function Research Research Personnel Risk Role Safety Saponin Saponins Scientist Serum Severities Signal Transduction Slice Somatomedins Source Soy Foods Soy Proteins Soybeans Symptoms System Time Toxic effect Treatment Efficacy United States United States National Institutes of Health Universities Upper arm Urine Vascular Endothelial Growth Factors absorption base cancer prevention cohort daidzein design dietary supplements evidence base evidence based guidelines experience glucosidase improved indexing interest meetings men novel pill prevent prostate cancer prevention public health relevance sound soy soy protein isolate survivorship tumor progression urinary

项目摘要

DESCRIPTION (provided by applicant): Rationale. The role of complementary and alternative interventions for prostate cancer prevention, and as an adjunct to treatment, is of great interest to the public and patients, but a highly contentious area among physicians and scientists. Soy is hypothesized, but not proven, to reduce the risk of prostate cancer or enhance the efficacy of therapy. One of the obstacles to soy consumption is the lack of consumer friendly, food-based, "phytochemical delivery systems". Our team of investigators have formulated two such systems: (a) a soy bread providing 33 mg isoflavones per 50g slice, and (b) 2-glucosidase-enriched soy bread that increases by 100% the aglycone form (potentially most active and more readily absorbed). Hypothesis. We hypothesize 2 -glucosidase-enriched soy bread will serve as an excellent source of bioavailable soy isoflavones for future phase II/III randomized clinical trials. Experimental Approach. We propose a randomized phase II cross-over trial in 40 men with prostate cancer and experiencing asymptomatic biochemical failure (rising PSA). Men will be randomized to consume 3 slices/day of soy bread or 2-glucosidase-enriched soy bread for 8 weeks and after a two week soy-free period cross over to the other arm for another 8 weeks. The following aims will be addressed. Aim 1. We hypothesize men will achieve excellent compliance with consumption of the soy breads with minimal toxicity. Aim 2. We hypothesize that consumption of the 2-glucosidase-enriched soy bread compared to control soy bread will result in an increase in the bioavailability of soy phytochemicals in the blood and provide distinct daidzein metabolite profiles. Aim 3. We hypothesize that consumption of the 2-glucosidase-enriched soy bread compared to control soy bread will have a greater effect on blood biomarkers that favor anti-cancer activity. Value: The proposed studies will characterize the ability of 2 -glucosidase-enriched soy bread to serve as a vehicle for bioactive soy phytochemicals in future definitive randomized clinical trails. PUBLIC HEALTH RELEVANCE: The public, including cancer patients, are in need of evidence based guidelines regarding dietary and nutritional products that may prevent cancer or enhance survivorship. We have developed novel soy bread products in our effort to bring desirable soy-based foods into clinical trials and, in the future, into the marketplace. The proposed study represents a critical assessment of soy bread safety/toxicity in men with prostate cancer, a group that is ideally suited for clinical trials of complementary and alternative therapy.

描述（由申请人提供）：理由。预防前列腺癌的互补和替代干预措施以及作为治疗的辅助性的作用引起了公众和患者的极大兴趣，但医生和科学家中的领域极为有争议。假设大豆是为了降低前列腺癌的风险或增强治疗的疗效。大豆消费的障碍之一是缺乏消费者友好的，基于食物的“植物化学输送系统”。我们的调查人员团队已经制定了两个这样的系统：（a）每50克片的大豆面包提供33毫克异黄酮，以及（b）2-葡萄糖苷酶富含大豆面包，增加了100％的aglycone形式（可能是最活跃的，更易于吸收的）。假设。我们假设2-葡萄糖苷酶含有富含大豆的大豆将成为生物利用的大豆异黄酮的绝佳来源，用于将来的II/III期随机临床试验。实验方法。我们提出了40名前列腺癌男性和无症状生化衰竭（PSA升高）的40名男性的II期交叉试验。男性将被随机消耗3片/天的大豆面包或2-葡萄糖苷酶的大豆面包，持续8周，经过两周的无大豆段时，再搭配另一只手臂，再过8周。将解决以下目标。目的1。我们假设男性将获得极大的依从性，以最少的毒性消耗大豆面包。目标2。我们假设与对照大豆面包相比，富含2-葡萄糖苷酶的大豆面包的消费将导致血液中大豆植物化学物质的生物利用度提高，并提供明显的大麦格代谢物概况。 AIM 3。我们假设与对照大豆面包相比，富含2-葡萄糖苷酶的大豆面包的消费将对有利于抗癌活性的血液生物标志物产生更大的影响。价值：拟议的研究将表征富含2-葡萄糖苷酶的大豆面包在未来确定的随机随机临床踪迹中作为生物活性大豆植物化学物质的载体的能力。公共卫生相关性：包括癌症患者在内的公众需要基于证据的饮食和营养产品指南，这些准则可能预防癌症或增强生存。我们开发了新颖的大豆产品，旨在将理想的基于大豆的食物带入临床试验，并将来将来进入市场。拟议的研究代表了对前列腺癌男性大豆面包安全/毒性的批判性评估，该小组非常适合互补和替代疗法的临床试验。