Intervention Study - Modulation of Cardiovascular Risk Factors by Personal Nutritional Counselling and Daily Menu Plans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- blood lipids
研究概览
简要总结
The interventional study will evaluate effectiveness and potential of a 'cardioprotective diet' for adults with increased risk for cardiovascular diseases (CVD). The 'cardioprotective diet' is characterized by adequate energy intake, intake of carbohydrates, protein and fat according to the guidelines of the German Society of Nutrition (DGE e. V.), with special focus on fat quality of the foods.
Half of the participants will consume additional n-3 long-chain (LC)-PUFA (3 g eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA)/d). The study participants receive defined personal nutritional counselling every two weeks and they get daily menu plans (with optimised nutrient profiles) over an entire period of 20 weeks (follow-up 20 weeks).
详细描述
The interventional study will evaluate effectiveness and potential of a 'cardioprotective diet' for adults with increased risk for cardiovascular diseases (CVD). The 'cardioprotective diet' is characterized by (i) adequate energy intake, (ii) intake of carbohydrates, protein, fat according to the guidelines of the German Society of Nutrition (DGE e. V.), (iii) desirable intake of saturated fatty acids (SFA, 7 En%), monounsaturated fatty acids (MUFA, > 10 En%), polyunsaturated fatty acids (PUFA, approx. 10 En%) and in particular n-3 LC-PUFA, (iv) encouraged consumption of vegetables, fruits, cereals, (v) salt and sugar reduction, (vi) avoiding of highly processed, calorie-dense, nutrient-poor food as well as (vii) encouraged physical activity.
Half of the participants will consume additional n-3 LC-PUFA (3 g EPA+DHA/d). The study participants receive defined personal nutritional counselling every two weeks and they get daily menu plans (with optimised nutrient profiles) over an entire period of 20 weeks (follow-up 20 weeks).
Besides the personal dialogues participants receive information materials providing the dietary recommendations, information to improve nutritional behavior and environment as well as various practical advices. Additionally, a weekly reminder strengthens the approach in addition to each visit at a 2-week interval.
The reflection about the implementation of the advices within day-to-day routine and the resulting challenges are an important part of the concept (feedback).
The identification of variables influencing people's nutritional behavior is attained and offers the possibility to address these variables within the recommendations that will be developed for adults with increased CVD risk as part of our nutriCARD strategy (Competence Cluster for Nutrition and Cardiovascular Health (nutriCARD), Halle-Jena-Leipzig, Germany).
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •LDL cholesterol ≥ 3 mmol/L
排除标准
- •intake of lipid-lowering medications
- •gastrointestinal diseases
- •familial hypercholesterolemia
- •intake of additional dietary supplements (especially fish oil capsules or vitamin E)
- •pregnancy, lactation
- •patient's request or if patient compliance with the study protocol is doubtful
结局指标
主要结局
blood lipids
时间窗: change from baseline at 20 weeks
total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) \[mmol/L\]
次要结局
- oral glucose tolerance test (blood)(change from baseline at 20 weeks)
- alpha prothrombin time (blood)(change from baseline at 20 weeks)
- Nutritional status I (blood)(change from baseline at 20 weeks)
- lipoprotein(a) (blood)(change from baseline at 20 weeks)
- height(change from baseline at 20 weeks)
- Nutritional status II (blood)(change from baseline at 20 weeks)
- Nutritional status III (blood)(change from baseline at 20 weeks)
- high sensitive c-reactive protein (blood)(change from baseline at 20 weeks)
- weight(change from baseline at 20 weeks)
- insulin (blood)(change from baseline at 20 weeks)
- HbA1c (blood)(change from baseline at 20 weeks)
- fatty acid distribution (blood)(change from baseline at 20 weeks)
- fibrinogen (blood)(change from baseline at 20 weeks)
- homocysteine (blood)(change from baseline at 20 weeks)
研究者
Christine Dawczynski,PhD
PhD
University of Jena