跳至主要内容
临床试验/NCT02078505
NCT02078505Unknown不适用

The Effect of Diet on the Microbiome of Women With Polycystic Ovary Syndrome

Meir Medical Center2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
change in microbial population of the colon

研究概览

简要总结

The polycystic ovary syndrome is intimately associated with body weight and nutrition.The genomic era did not bring a breakthrough to the understanding of the syndrome. The recent surge of studies on gut microbiome has raised the possibility that the specific diet, which often affect these women favorably, would change their gut microbiome. Hence, the investigators will examine their gut microbial population in comparison to normal ovulatory women and then examine whether a low carbohydrate diet causes favorable change in their gut microbial population.

详细描述

  • Scientific Background

Infertility is a major health problem that affects up to 15% of married couples. About half of these cases are attributable to female factors, among which anovulation is the leading cause. About 5% of all women of reproductive age are anovulatory due to the polycystic ovarian syndrome (PCOS). In addition to its effect on fertility, PCOS causes major health and cosmetic problems and significantly affects quality of life in women. PCOS is associated with cardiovascular morbidity and Type 2 diabetes mellitus, but it is unclear whether these are caused by the ovarian dysfunction or result from a common denominator.

  • PCOS
  • The clinical picture:

The polycystic ovary syndrome consists of anovulation, acne, hirsutism (resulting from hyperandrogenism), and reversed serum LH to FSH ratio. A large proportion of women with PCOS are overweight, and a significant proportion of women with PCOS have decreased peripheral insulin sensitivity. The direct cause to this insulin resistance is still enigmatic. All these features place women with PCOS as a group of patients related to the metabolic syndrome. Baranova et al. (2011) even stated that "it seems appropriate to consider polycystic ovary syndrome as the ovarian manifestation of metabolic syndrome".

  • Genetics

研究设计

研究类型
Interventional
分配方式
Non Randomized
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 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Study group - no other etiologies for infertility

排除标准

  • Other etiologies for infertility

研究组 & 干预措施

PCOS after diet

Experimental

Patients after 2 months of diet

干预措施: diet (Behavioral)

control

No Intervention

Ovulatory women

结局指标

主要结局

change in microbial population of the colon

时间窗: 2 months of diet

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)

Loading locations...

相似试验