Effects of a Legume-rich Diet in the Context of the Planetary Health Diet Compared to a Western-oriented Dietary Pattern in Women and Men At Increased Risk of Cardiovascular and Neurodegenerative Diseases
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Pameters of glucose metabolism in blood
研究概览
简要总结
The aim of the study is to systematically investigate the effects of a diet enriched with legumes in a dietary pattern approach (Planetary Health Diet) compared to a control diet low in legumes in older people with a risk phenotype for cardiovascular and neurodegenerative diseases. For this purpose, a controlled, six-week nutritional intervention study will be carried out in a parallel design. A total of 100 subjects (aged 50 - 75 years) will be randomly assigned to one of two intervention groups: i) a legume-rich diet based on the Planetary Health Diet, with a focus on plant protein, ii) a diet based on the Western dietary pattern including animal protein sources (= control diet). The target variables include parameters of lipid, glucose and insulin metabolism as well as biomarkers of inflammation and endothelial activation, proteomics and neurodegeneration markers. Furthermore, pulse wave velocity is measured to assess vascular function and neuropsychological target variables (e.g. hunger, satiety) are recorded using questionnaires.
详细描述
The aim of the study is to systematically investigate the effects of a diet enriched with legumes in the dietary pattern approach (Planetary Health Diet) compared to a control diet low in legumes in older people with a risk phenotype for cardiovascular and neurodegenerative diseases. For this purpose, a controlled, six-week nutritional intervention study will be carried out in a parallel design. A total of 100 subjects (aged 50 - 75 years) will be randomly assigned to one of two intervention groups: i) a legume-rich diet based on the Planetary Health Diet, with a focus on plant protein, ii) a diet based on the Western dietary pattern including animal protein sources (= control diet). The target variables include parameters of lipid, glucose and insulin metabolism as well as biomarkers of inflammation and endothelial activation, proteomics and neurodegeneration markers. Furthermore, pulse wave velocity is measured to assess vascular function and neuropsychological target variables (e.g. hunger, satiety) are recorded using questionnaires. The subjects come to the study center for examination before the start of the intervention (visit 1), after three weeks (mid-intervention, visit 2) and after six weeks (end of intervention, visit 3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent
- •Non-smoking
- •BMI: 27 - 34,9 kg/m2
- •Waist circumference (women ≥ 80 cm, men ≥ 94 cm)
- •Systolic blood pressure: ≥ 120 mmHg, diastolic blood pressure: ≥ 80 mmHg
- •At least one of the following criteria:
- •Fasting triglycerides in serum: ≥ 150 mg/dL
- •Fasting LDL cholesterol in serum ≥160 mg/dL
- •Fasting HDL-Cholesterol in serum: women < 50 mg/dl, men < 40 mg/dL
- •Fasting glucose in plasma: ≥ 100 mg/dL
- •CRP in serum 0,2-3 mg/dL
排除标准
- •food intolerances and allergies (especially legumes)
- •malabsorption syndromes
- •thyroid diseases
- •impaired renal function
- •chronic liver disease
- •heart failure
- •myocardial infarction
- •insulin-dependent diabetes mellitus
- •chronic inflammatory diseases
- •immunosuppression
- •intake of supplements (e.g., fish oil)
- •Participation in another study
- •other exclusion criteria at the discretion of the physician/ investigator
结局指标
主要结局
Pameters of glucose metabolism in blood
时间窗: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention
Glucose (mg/dL)
次要结局
- Blood urea(Fasting (t=0) in week 1 and week 6 of intervention)
- Uric acid in blood(Fasting (t=0) in week 1 and week 6 of intervention)
- Parameters of endothelial function in blood(Fasting (t=0) in week 1 and week 6 of intervention)
- Liver enzymes(Fasting (t=0) in week 1 and week 6 of intervention)
- Parameters oft the antioxidant system(Fasting (t=0) in week 1 and week 6 of intervention)
- Parameters of inflammation in blood(Fasting (t=0) in week 1 and week 6 of intervention)
- Parameters of Hunger and Satiety in blood(Fasting (t=0) in week 1 and week 6 of intervention)
- Endothelial function(Fasting (t=0) in week 1 and week 6 of intervention)
- Small blood count(Fasting (t=0) in week 1 and week 6 of intervention)
- Ferritin(Fasting (t=0) in week 1 and week 6 of intervention)
- Adiponectin(Fasting (t=0) in week 1 and week 6 of intervention)
- trace elements(Fasting (t=0) in week 1 and week 6 of intervention)
- Proteomics(Fasting (t=0) in week 1 and week 6 of intervention)
- Blood pressure(Fasting (t=0) in week 1 and week 6 of intervention)
- REE(Fasting (t=0) in week 1 and week 6 of intervention)
- Neuropsychological parameters(Fasting (t=0) in week 1 and week 6 of intervention)
- Fecal fatty acid profile(Fasting (t=0) in week 1 and week 6 of intervention)
- Parameters of glucose metabolism in blood(Fasting (t=0) in week 1 and week 6 of intervention)
- Parameters of lipid metabolism in blood(Fasting (t=0) in week 1 and week 6 of intervention)
- Neurodegenerative markers(Fasting (t=0) in week 1 and week 6 of intervention)
- Anthropometic measurements(Fasting (t=0) in week 1 and week 6 of intervention)
研究者
Prof. Dr. Sarah Egert
Prof. Dr. Sarah Egert
University of Bonn