Dietary Patterns, Cardiometabolic Risk Factors and Menopause Symptoms in a Sample of UK Women - A Randomised Cross-over Parallel Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change triglycerides baseline - interim point
研究概览
简要总结
This research will explore the question 'What impact do the Mediterranean Diet (MedDiet) and the Heart UK Ultimate Cholesterol Lowering Plan (UCLP) Menopause have on cardiometabolic risk factors and the frequency and severity of menopause symptoms? This is a randomised cross-over parallel trial of 12 weeks duration. Participants are women undergoing or having completed the menopause transition.
详细描述
Group 1 will first follow the MedDiet pattern for six weeks and then follow the UCLP diet pattern for six weeks. Group 2 will also follow both diet patterns but in the opposite order.
Week 0 will be the baseline, week 6 will be the interim point and week 12 will be the endpoint.
Data collection Some data will be collected at the University of Chester laboratories, including anthropometric measurements, blood pressure and blood samples. A small fasted blood sample will be collected via finger prick (Alere Cholestech LDX® Analyzer (Alere San Diego Inc. USA)). Participants will also be talked through the guidance notes for the diets at this point. Other data, food diaries and a questionnaire asking about recent physical activity and menopause symptoms will be completed online.
Demographics At baseline participants will be asked to complete a brief questionnaire to answer a few demographic questions, including date of birth, ethnicity, income category, level of education, whether (and if so which) using any form of hormone replacement therapy (HRT) or contraception. Participants will be asked at interim and endpoint whether there have been any recent changes with regards to HRT and contraception methods.
Dietary intake Participants will be asked to complete a total of seven four-day food diaries. The first diary will be completed in the week before participants attend their first appointment in the laboratory. This diary will give a snapshot of the participants' habitual diet prior to joining the intervention. The other four-day food diaries will be completed in weeks 2, 4, 6, 8, 10 and 12.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •over the past year presented with any of the following
- •Irregular periods or no periods at all
- •Night sweats
- •Hot flushes
- •Sleeplessness
- •Increased anxiety
- •Changes to hair or skin
排除标准
- •Ever had an eating disorder
- •Ever diagnosed with cardiovascular disease or type 2 diabetes
- •Ever diagnosed with kidney disease
- •Current smoker
- •Triglyceride levels of ≥ 5.7 mmol/L at baseline
- •Glucose levels of ≥ 7 mmol/L at baseline
- •Diastolic blood pressure of ≥ 100 mmHg at baseline
- •Systolic blood pressure of ≥ 160 mmHg at baseline
结局指标
主要结局
Change triglycerides baseline - interim point
时间窗: 6 weeks
Change from baseline triglyceride concentrations at 6 weeks
Change triglycerides - baseline - endpoint
时间窗: 12 weeks
Change from baseline triglyceride concentrations at 12 weeks
Change LDL cholesterol interim point - endpoint
时间窗: 6 weeks
Change from interim point LDL cholesterol concentrations at 12 weeks
Change triglycerides interim point - endpoint
时间窗: 6 weeks
Change from interim point triglyceride concentrations at 12 weeks
Change Total cholesterol baseline-interim point
时间窗: 6 weeks
Change from baseline total cholesterol concentrations at 6 weeks
Change Total cholesterol interim point - endpoint
时间窗: 6 weeks
Change from interim point total cholesterol concentrations at 12 weeks
Change HDL cholesterol baseline - interim point
时间窗: 6 weeks
Change from baseline HDL cholesterol concentrations at 6 weeks
Change HDL cholesterol baseline - endpoint
时间窗: 12 weeks
Change from baseline HDL cholesterol concentrations at 12 weeks
Change LDL cholesterol baseline-interim point
时间窗: 6 weeks
Change from baseline LDL cholesterol concentrations at 6 weeks
Change LDL cholesterol baseline - endpoint
时间窗: 12 weeks
Change from baseline LDL cholesterol concentrations at 12 weeks
Change non-HDL cholesterol baseline - interim point
时间窗: 6 weeks
Change from baseline non-HDL cholesterol concentrations at 6 weeks
Change non-HDL cholesterol baseline - endpoint
时间窗: 12 weeks
Change from baseline non-HDL cholesterol concentrations at 12 weeks
Change non-HDL cholesterol interim point - endpoint
时间窗: 6 weeks
Change from interim point non-HDL cholesterol concentrations at 12 weeks
Change Systolic and diastolic blood pressure baseline - endpoint
时间窗: 12 weeks
Change from baseline blood glucose concentrations at 12 weeks
Change Waist-height ratio interim point - endpoint
时间窗: 6 weeks
Change from interim point waist-height ratio at 12 weeks
Change HDL cholesterol interim point - endpoint
时间窗: 6 weeks
Change from interim point HDL cholesterol concentrations at 12 weeks
Change Waist circumference baseline - interim point
时间窗: 6 weeks
Change from baseline waist circumference at 6 weeks
Change Waist circumference interim point - endpoint
时间窗: 6 weeks
Change from interim point waist circumference at 12 weeks
Change Waist-hip ratio interim point - endpoint
时间窗: 6 weeks
Change from interim point waist-hip ratio at 12 weeks
Change Total cholesterol baseline-endpoint
时间窗: 12 weeks
Change from baseline total cholesterol concentrations at 12 weeks
Change blood glucose baseline - endpoint
时间窗: 12 weeks
Change from baseline blood glucose concentrations at 12 weeks
Change Body mass index baseline - endpoint
时间窗: 12 weeks
Change from baseline body mass index at 12 weeks
Change Waist circumference baseline - endpoint
时间窗: 12 weeks
Change from baseline waist circumference at 12 weeks
Change Waist-hip ratio baseline - endpoint
时间窗: 12 weeks
Change from baseline waist-hip ratio at 12 weeks
Change Waist-height ratio baseline - interim point
时间窗: 6 weeks
Change from baseline waist-height ratio at 6 weeks
Change Waist-height ratio baseline - endpoint
时间窗: 12 weeks
Change from baseline waist-height ratio at 12 weeks
Change blood glucose baseline - interim point
时间窗: 6 weeks
Change from baseline blood glucose concentrations at 6 weeks
Change blood glucose interim point - endpoint
时间窗: 6 weeks
Change from interim point blood glucose concentrations at 12 weeks
Change Systolic and diastolic blood pressure baseline - interim point
时间窗: 6 weeks
Change from baseline systolic and diastolic blood pressure at 6 weeks
Change Body mass index - baseline - interim point
时间窗: 6 weeks
Change from baseline body mass index at 6 weeks
Change Waist-hip ratio baseline - interim point
时间窗: 6 weeks
Change from baseline waist-hip ratio at 6 weeks
Change Systolic and diastolic blood pressure - interim point - endpoint
时间窗: 6 weeks
Change from interim point blood glucose concentrations at 12 weeks
Change Body mass index - interim point - endpoint
时间窗: 6 weeks
Change from interim point body mass index at 12 weeks
次要结局
- Change Severity of menopause symptoms baseline - endpoint(12 weeks)
- Change Frequency of menopause symptoms baseline - interim point(6 weeks)
- Change Severity of menopause symptoms interim point - endpoint(6 weeks)
- Change Frequency of menopause symptoms baseline - endpoint(12 weeks)
- Change Severity of menopause symptoms baseline - interim point(6 weeks)
- Change Frequency of menopause symptoms - interim point - endpoint(6 weeks)
研究者
Tanja Harrison
Lecturer in Public Health Nutrition
University of Chester