Effects of Inofolic NRT on Post-menopausal Women Affected by the Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- percentage reduction of women with metabolic syndrome
研究概览
简要总结
A prospective, randomized, controlled, open-label study will be carried out on 80 post-menopausal women affected by the metabolic syndrome (criteria are described in NIH ATP III). After a written informed consent, women will be randomly treated for 6 months with hypocaloric diet (control group) or with diet and a supplementation of myo-inositol 2000 mg plus cocoa polyphenols 30 mg and plus isoflavones 80 mg. will be given randomly Eighty post-menopausal women, affected by metabolic syndrome will be randomized into two groups: 40 treated with myo-inositol 2 g twice per day and forty treated with placebo for six months. The investigators hypothesize that the administration of myo-inositol would improve the insulin-receptor activity in these women, reducing insulin resistance.
详细描述
Inclusion Criteria: post-menopausal women (12 months after last menstruation) affected by metabolic syndrome according to ATP III, 2001.
At least 3 of following 5 criteria must be present:
- waist circumference > 88 cm
- Triglycerides > 150 mg/dl
- HDL-cholesterol < 50 mg/dl
- Fast glycemia > 110 mg/dl
- Systolic blood pressure > 135 mmHg. diastolic > 85 mmHg -
Exclusion Criteria:1) post-menopausal women with less than 12 months from the last menstruation 2) less than 3 criteria according with ATP III 3) TSH > 3.5 4) in treatment with drugs lowering glycemia or cholesterol 5) allergy to cocoa
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •post-menopausal women (12 months after last menstruation) affected by metabolic syndrome according to ATP III,
- •At least 3 of following 5 criteria must be present:
- •waist circumference > 88 cm
- •Triglycerides > 150 mg/dl
- •HDL-cholesterol < 50 mg/dl
- •Fast glycemia > 110 mg/dl
- •Systolic blood pressure > 135 mmHg. diastolic > 85 mmHg -
排除标准
- •post-menopausal women with less than 12 months from the last menstruation
- •less than 3 criteria according with ATP III
- •in treatment with drugs lowering glycemia or cholesterol
- •allergy to cocoa
结局指标
主要结局
percentage reduction of women with metabolic syndrome
时间窗: at baseline and after 6 months.
evaluation of metabolic syndrome criteria according with ATP III 2001
次要结局
- Improvement of lipid profile(at baseline and after 6 months)
- reduction of insulin resistance(at baseline and after 6 months)
- variation in serum concentration of adiponectin, visfatin and resistin(at baseline and after 6 months)
研究者
Rosario D'anna
associate professor
University of Messina