Time-restricted Eating as a Novel Approach to PCOS Remission, Compared to Guideline's Standard Hormonal Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- PCOS Rotterdam criteria
研究概览
简要总结
The purpose of this study is to assess the effects of Time restricted eating in patients diagnosed with polycystic ovary syndrome, comparing it to the standard hormonal treatment.
详细描述
After being informed about the study and potential risks, all patients were given a written informed consent. Patients were recruited through social media and digital questionnaires, to make sure they met the criteria. There was a semi aleatory distribution of the patients into three different groups, one group underwent time restricted eating with no hormonal treatment (TRE group), the second group received hormonal treatment combined with time restricted eating (combined group) and the last group received only hormonal treatment (HT). PCOS was diagnosed using Rotterdam criteria, which were evaluated according to the ultrasound, blood samples and self reported menstrual cycle.
Blood samples and transvaginal ultrasound were taken at day 0 and 90 to evaluate hormonal status, including insulin and glucose.
Homeostatic assessment for insulin resistance (HOMA-IR) was calculated to determine insulin resistance, as well as metabolic disfunction.
After data collection, statistical analyses was done to determine the effect of the different approaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 20 - 35 years
- •Mild to moderate exercise at least 4 times per week
- •Body Mass Index (BMI) of 20-24.9
- •Diagnosis of PCOS by Rotterdam criteria
- •Type of oral contraceptives: combined (estrogens and progestins) in group 1 and
- •PCOS Phenotype A, B, C
- •nulliparity
- •Signed informed consent letter
排除标准
- •Menopause or perimenopause
- •Night work shifts
- •Phenotype D (without hyperandrogenism)
- •Associated pathologies such as diabetes mellitus, arterial hypertension, metabolic syndrome, neoplasms, autoimmune diseases.
- •Intake of medications on a regular basis, not including oral contraceptives for group 1 and 2.
结局指标
主要结局
PCOS Rotterdam criteria
时间窗: 3 months
Ovary volume \>9ml, presence of 12 or more follicles, biochemical or clinical signs of hyperandrogenism and anovulation.
次要结局
- Insulin resistance (IR)(3 months)
研究者
Isabela von Damm Longoria
Principal investigator
Instituto Superior de Investigación en Estética Médica, Nutrición y Anti-Envejecimiento