Walnuts, Walnut-Oil, Glucose Homeostasis, PCOS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- The investigators hope to learn the effects of walnuts, walnut-oil, almonds and fish oils on blood sugar and insulin levels in PCOS patients.
研究概览
简要总结
The purpose of this study is to learn more about the effects of walnuts, walnut-oil, almonds and fish oils on blood sugar and insulin levels in polycystic ovary syndrome (PCOS) patients. The hypothesis is that a diet rich in these foods will improve insulin resistance in women with PCOS.
详细描述
Polycystic ovary syndrome is a common disease that affects 1 out of 16 women. Metabolic and endocrine abnormalities seen in PCOS include insulin resistance, androgen excess and infertility. This study focuses on the insulin resistance aspect because increased insulin resistance leads to premature onset of impaired glucose tolerance or diabetes whereas decreased insulin resistance reduces androgen excess, improves the ovarian function and increases fertility. Although insulin resistance can be treated with insulin-sensitizing drugs, PCOS clinically manifests during adolescence and the long-term safety of the drug-treatment can be a concern. Thus, improving insulin resistance with effective nutritional approaches would be very desirable. Epidemiological studies and animal experiments suggest that replacement of dietary saturated fats with monounsaturated (MUFA) and polyunsaturated (PUFA) fats improves insulin resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Clinical diagnosis of polycystic ovary syndrome
- •Body mass index (BMI) 22-52
排除标准
- •Habitual dietary intake of less than 30% fat
- •Use of oral contraceptives, insulin sensitizers, d-chiro inositol, or any other supplements affecting weight or insulin sensitivity during the preceding two months
- •Impaired glucose tolerance
- •Diabetes mellitus
- •Other system illnesses such as renal, hepatic, gastrointestinal, severe hyperlipidemia and hypertension that require medication
- •Smoking, alcohol intake (more than 2 drinks/week)
- •The laboratory values used for exclusion of subjects will be fasting glucose > 110 mg/dl, glycosylated hemoglobin (HgBA1) > 6.5%, serum creatinine > 1.5 mg/dl, ALT or AST > 2x the upper limit of normal, cholesterol > 250 mg/dl. The investigators will also exclude subjects with hematocrit < 30%.
结局指标
主要结局
The investigators hope to learn the effects of walnuts, walnut-oil, almonds and fish oils on blood sugar and insulin levels in PCOS patients.
时间窗: 3 years
次要结局
未报告次要终点