Effects of a Synergistic Food Basket on Markers of Metabolic Syndrome Risk in Healthy Mature Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change from baseline in LDL cholesterol after each dietary period
研究概览
简要总结
The study evaluates the effect of a diet combining two different functional concepts on markers associated to cardiometabolic risk. The functional concepts are selected on the basis of their reported ability to influence the inflammatory tonus. It is hypothesized that the medium-term consumption of a diet combining low GI-prebiotic foods may positively influence various biomarkers associated with the risk for developing metabolic syndrome and cardiometabolic disease. Also, the combination of functional mechanisms are expected to result in synergistic effects.
详细描述
The intervention is carried out in healthy women following a randomized crossover design in which an "active" (functional") diet is compared with a control diet formulated in agreement with the Nordic Dietary Recommendations but lacking the functional ingredients of the active regime.
The active diet supplies important daily amounts of dried legumes and wholegrain cereal products.
Each dietary treatment is applied for 4 weeks separated by a 4-6 week washout period. Subjects are encouraged to maintain a stable body weight under the whole trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI between 25 and 32 kg/m2
排除标准
- •Fasting blood glucose > 6.1 mmol/L
- •Medication for high blood pressure and/or elevated blood cholesterol
研究组 & 干预措施
Active Diet
Subjects eat a diet designed according to the Nordic Dietary Recommendations containing important amounts of specific legume and cereal ingredients that provide substrates for the intestinal microflora (prebiotics)
干预措施: Synergistic food basket (Other)
Control diet
Subjects eat a diet designed according to the Nordic Dietary Recommendations but lacks the specific legume and cereal ingredients that provide substrates for the intestinal microflora (prebiotics).
干预措施: Synergistic food basket (Other)
结局指标
主要结局
Change from baseline in LDL cholesterol after each dietary period
时间窗: Week 0 and after 4 weeks (Start and End of the intervention arm)
次要结局
- Change from baseline in LDL-cholesterol/HDL-cholesterol after each dietary period(Week 0 and after 4 weeks (Start and End of the intervention arm))
- Change from baseline in fasting CRP after each dietary period(Week 0 and after 4 weeks (Start and End of the intervention arm))
- Change from baseline in waist circumference after each dietary period(Week 0 and after 4 weeks (Start and End of the intervention arm))
- Change from baseline in fasting plasma PYY after each dietary period(Week 0 and after 4 weeks (Start and End of the intervention arm))
- Change from baseline in fasting plasma insulin after each dietary period(Week 0 and after 4 weeks (Start and End of the intervention arm))
- Change from baseline in BMI after each dietary period(Week 0 and after 4 weeks (Start and End of the intervention arm))
- Change from baseline in blood pressure after each dietary period(Week 0 and after 4 weeks (Start and End of the intervention arm))
- Change from baseline in fasting plasma glucose after each dietary period(Week 0 and after 4 weeks (Start and End of the intervention arm))
- Change from baseline in fasting plasma PAI-1 after each dietary period(Week 0 and after 4 weeks (Start and End of the intervention arm))
- Change from baseline in HOMA-IR after each dietary period(Week 0 and after 4 weeks (Start and End of the intervention arm))
- Change from baseline in fasting plasma triglycerides after each dietary period(Week 0 and after 4 weeks (Start and End of the intervention arm))
研究者
Juscelino Tovar
Project Manager
Lund University