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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiovascular Diseases
- Sponsor
- University of Bonn
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Pameters of glucose metabolism in blood
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Prof. Dr. Sarah Egert
Prof. Dr. Sarah Egert
University of Bonn
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Pameters of glucose metabolism in blood
Time Frame: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention
Glucose (mg/dL)
Secondary Outcomes
- 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)
- 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)
- 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)
- Liver enzymes(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)
- Parameters oft the antioxidant system(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)
- Neurodegenerative markers(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)
- Anthropometic measurements(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)