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临床试验/NCT00693082
NCT00693082终止2 期

Polycystic Ovarian Syndrome: Impact of Flaxseed Supplementation

Duke University2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2007年8月最近更新:
适应症

试验速览

阶段
2 期
状态
终止
入组人数
4
试验地点
2
主要终点
To explore the effects of flaxseed supplementation on women with clinically confirmed PCOS.

研究概览

简要总结

The overall aim of this study is to explore the effects of flaxseed supplementation and determine whether it is a feasible and potentially effective dietary intervention among women with polycystic ovarian syndrome (PCOS). Women, ages 18-45, with clinically confirmed PCOS (N=20) will be scheduled for baseline measures and then instructed and given supplies necessary to follow a flaxseed supplemented (30 g/day) diet for a period of three months, whereupon follow-up measures will be taken. Subjects will be asked to resume their typical (unsupplemented) diet for another three months and a second set of follow-up measures will be taken. Baseline levels of bioavailable and total testosterone, fasting insulin, glucose, and triglycerides (TG), total/LDL/HDL cholesterol, body weight, degree of hirsutism and acne, and menstrual cyclicity will be compared to levels at 3 and 6 month follow-up. The overall hypothesis (based upon our work in men at risk for prostate cancer and data from one case-study conducted in a woman with confirmed PCOS) is that during the time women receive flaxseed supplementation they will experience reduced serum levels of testosterone, and total and LDL cholesterol, as well as clinical evidence of hirsutism. Given the pilot nature of this study, statistical analyses will be limited to simple descriptive statistics. We have observed no negative side effects, other than minor gastro-intestinal occurrences (i.e., temporary increased flatulence, borborygmi, increased number of stools, etc.) associated with flaxseed supplementation in our previous studies either with short or long-term use. Flaxseed supplementation will be discontinued if indicated and the events reported to the institutional review board.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • limited to women aged 18-45
  • diagnosis of PCOS by menstrual irregularity (fewer than 9 menses annually), Ferriman-Gallwey score > 8, and/or hyperandrogenemia defined as bioavailable T>8.4ng/dL (Zawdaki & Dunaif 1992)
  • mentally competent
  • English speaking/writing
  • telephone access and/or email access

排除标准

  • Use of oral contraceptives, spironolactone or insulin-sensitizing agents within the past 3 months;
  • Long-term or chronic use of oral antibiotics;
  • Diagnoses of hyperprolactinemia, thyroid abnormalities, or nonclassic adrenal hyperplasia;
  • Hysterectomy;
  • Onset of menopause;
  • Pregnancy/Lactation;
  • Consumption of flaxseed within the past month; and
  • Use of any dietary fiber supplements which are newly started (within the past 6 months) and agreement not to use any new fiber supplements during the study period

结局指标

主要结局

To explore the effects of flaxseed supplementation on women with clinically confirmed PCOS.

时间窗: baseline, 12 weeks, 24 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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