Assessment of Cod Protein as an Insulin-sensitizing Agent in Women With Polycystic Ovary Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Change in ovarian function during intervention period.
研究概览
简要总结
The objective of our study is to determine the effects of fish protein on insulin sensitivity in PCOS women with insulin resistance, and its mechanism of action on glucose and endocrine metabolism. Our working hypothesis is that dietary fish protein improves insulin sensitivity, glucose tolerance, and related plasma endocrine and lipid abnormalities in PCOS women by restoring secretory β-cell function and insulin signaling to the PI 3-kinase activity/Akt pathway. We further hypothesize that fish protein will improve cycle regularity and ovarian function.
详细描述
Women with polycystic ovary syndrome are at high risk of developing diabetes. Apart from a primary ovarian defect, up to 10% and 40-50% of those women develop diabetes and insulin resistance (IR) respectively. IR and associated hyperinsulinemia are recognized as important pathogenic factors in determining diabetes in the majority of PCOS women, particularly when obesity is present. Treating IR might reduce the risk of diabetes and improve ovulation and fertility in PCOS women. We recently found that obese, IR men and women consuming a cod protein diet showed a 30% improvement in insulin sensitivity compared with other animal proteins, and also a 24% decrease in high-sensitive C-reactive protein plasma concentration. Therefore, dietary fish protein could represent a natural, safe and practical means to improve insulin sensitivity in PCOS women with IR, and a new non-pharmaceutical approach for the treatment of the multiple endocrine and metabolic abnormalities of PCOS women (see outcome measures for a more extensive description).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 是
入选标准
- •18 to 45 years old
- •having polycystic ovarian syndrome
- •overweight (BMI>27)
- •insulin resistance based on fasting insulin levels in the upper 95th percentile (>90pmol/L)
- •non-diabetic
排除标准
- •hysterectomy
- •abnormal endometrial biopsy if abnormal bleeding in the last 6 months
- •clinical evidence of Cushing's syndrome
- •congenital adrenal hyperplasia (17-OH progesterone>10nmol/l)
- •excessive androgens suspicious of a tumour
- •prolactins levels >50μg/l
- •previous breast, uterus, ovary or liver neoplasia
- •use of medication known to affect glucose and lipid metabolisms (e.g. steroid hormones, oral contraceptives, ß-blockers, glitazones, statins, insulin)
- •depo-medroxyprogesterone acetate injection in the last year
- •important weight loss or weight gain within the last 6 months
- •chronic, metabolic (except well controlled chronic hypothyroidism) or acute disease or major surgery within the last 3 months
- •dietary incompatibility with calcium supplementation and/or fish consumption (allergy, intolerance, dislike)
研究组 & 干预措施
Semi-controlled intervention with fish protein diet
Women with polycystic ovarian syndrome who are assigned to a 12 weeks experimental diet containing cod as the protein source.
干预措施: Semi-controlled nutritional intervention with fish protein diet (Other)
Semi-controlled intervention with other animal proteins
Women with polycystic ovarian syndrome who are assigned to a 12 week experimental diet containing beef, pork, veal, eggs and milk products (BPVEM) as protein sources.
干预措施: Semi-controlled intervention with other animal proteins (Other)
结局指标
主要结局
Change in ovarian function during intervention period.
时间窗: At weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 during the intervention
progesterone measurements
Change in cycle regularity during intervention period.
时间窗: At weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 during the intervention
menstrual diaries
Change in sex hormones, during intervention and from baseline to the end of each intervention period.
时间窗: At baseline, after the wash-out period, at the end of each intervention period (12 weeks), and at weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 during the intervention.
Detailed plasma androgen profile including active androgens (testosterone and dihydrotestosterone), adrenal androgens (androstenedione, dehydroepiandrosterone and its sulphate), major glucuronide-conjugated androgen metabolites, plasma levels of the sex hormone transport protein Sex Hormone-Binding Globulin (SHBG).
次要结局
- Change in anthropometric measurements from baseline to the end of each intervention period.(At baseline and at the end of the intervention period (12 weeks))
- Change in nutritional variables from baseline to the end of each intervention period.(At baseline and at the end of the intervention period (12 weeks).)
- Change in physical activity habits from baseline to the end of each intervention period.(At baseline and at the end of the intervention period (12 weeks))
- Change in cardiometabolic statute from baseline to the end of each intervention period(At baseline (at the beginning of the intervention), after the 12 weeks wash-out period, and at the end of each intervention period (12 weeks each))
- Muscle insulin signaling(After each intervention period (12 weeks))
研究者
Helene Jacques
Professor, Ph.D., Dt.P.
Laval University