Soy Isoflavones for Menopausal Vasomotor Symptoms

大豆异黄酮治疗更年期血管舒缩症状

• 批准号: 6968333
• 负责人: JUDITH K OCKENE
• 金额: $ 32.4万
• 依托单位: UNIV OF MASSACHUSETTS MED SCH WORCESTER
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6968333
• 关键词: clinical research; clinical trials; data collection methodology /evaluation; drug administration rate /duration; female; flavonoids; gas chromatography mass spectrometry; hot flash; human subject; human therapy evaluation; isotope dilution method; menopause; outcomes research; pharmacokinetics; quality of life; soybeans; sweat; therapy compliance; urinalysis; vasomotion; women' s health

DESCRIPTION (provided by applicant): Vasomotor symptoms (VMS), including hot flashes and night sweats, affect the majority of menopausal women. Since the results of the Women's Health Initiative were publicized, many women and their health care providers no longer wish to use hormone therapy for VMS. Soy isoflavones have been marketed for reducing VMS, but data are inconclusive as to their effectiveness. Although isoflavones are structurally similar to estrogen and thus bind to estrogen receptors, results from randomized controlled trials of both soy foods and supplements have been mixed. Given the pharmacokinetic characteristics of soy isoflavones, in particular the half-life (approximately 8 hours), dosing frequency may be critical to their effectiveness in reducing VMS. In addition, no intervention study of VMS has examined whether participants are equol producers. Equol, daidzein's active metabolite, may affect the efficacy of daidzein in reducing VMS intensity. We propose to conduct a small pilot randomized placebo-controlled trial under the R21 mechanism of 180 menopausal women with moderate to severe VMS to examine a range of doses (total daily dose of 100 mg/day and 200 mg/day) and three dosing frequencies (1, 2, and 3 times a day) of capsules containing the primary isoflavones found in soy (daidzein and genistein). Outcomes will include feasibility and preliminary dose evaluation. For feasibility aims we will: 1) assess our ability to recruit and retain participants; 2) measure adherence to capsules and to completing symptoms diaries; 3) modify and test a daily symptoms diary that is more complex than previously used; and 4) test the feasibility and utility of identifying equol producer status. For preliminary dose evaluation aims we will examine VMS as they relate to: 1) isoflavones by dose amount and dose frequency; 2) equol producer status; and 3) in a subgroup, steady state concentrations. These data will provide essential information for optimal study design, methods of data collection, and total daily dose and dosing frequency for a larger, more definitive randomized controlled trial.

描述（由申请人提供）：血管舒缩症状（VM），包括潮热和夜汗，会影响大多数绝经女性。由于公开了妇女健康计划的结果，因此许多妇女及其医疗保健提供者不再希望将激素治疗用于VM。大豆异黄酮已经用于减少VM的销售，但数据对其有效性尚无定论。尽管异黄酮在结构上与雌激素相似，因此与雌激素受体结合，但混合了大豆食品和补充剂的随机对照试验的结果。考虑到大豆异黄酮的药代动力学特征，尤其是半衰期（大约8小时），剂量频率对于它们在降低VM中的有效性可能至关重要。此外，对VM的干预研究尚未研究参与者是否是stequol生产者。大豆活性代谢产物Equol可能会影响大麦（Daidzein）降低VM强度的功效。我们建议通过180个中度至重度VM的R21机制进行一项小型试验安慰剂对照试验，以检查一系列剂量（每日总剂量为100 mg/day和200 mg/day）和三种给药频率（每天1、2和3次）（每天1、2和3次），其中包含capsuls capsuls and capsuls and capsuls and capsine and capsin and centey and geniste and geniste and and and and geniste and and and niste and and and and niste and。结果将包括可行性和初步剂量评估。为了可行性，我们将：1）评估我们招募和留住参与者的能力； 2）测量对胶囊的依从性并完成症状日记； 3）修改和测试每日症状日记，该日记比以前使用的更为复杂； 4）测试识别stequol生产者状态的可行性和效用。对于初步剂量评估目的，我们将检查VM与：1）异黄酮的剂量和剂量频率相关； 2）Equol生产者身份； 3）在亚组，稳态浓度中。这些数据将为最佳研究设计，数据收集方法以及总每日剂量和剂量频率提供必不可少的信息，以提供更大，更确定的随机对照试验。