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| Name | Class |
|---|---|
| Federal Ministry of Food and Agriculture (BMEL) | UNKNOWN |
| Federal Office of Agriculture and Food (BLE) | UNKNOWN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| legume-rich Planetary Health Diet | Experimental | legume-rich diet based on the Planetary Health Diet, with a focus on vegetable protein |
|
| control diet based on Western Diet low in legumes | Experimental | diet based on the Western dietary pattern including animal protein sources (= control diet) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| legume-rich Planetary Health Diet | Other | legume-rich diet based on the Planetary Health Diet, with a focus on vegetable protein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pameters of glucose metabolism in blood | Glucose (mg/dL) | postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Parameters of glucose metabolism in blood | Insulin (nmol/L) | postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention |
| Parameters of glucose metabolism in blood | GLP-1 (pg/mL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Egert, Prof PhD | Contact | + 49 (0) 228 / 73 59 53 | s.egert@uni-bonn.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Nutritional and Food Sciences, Nutrition Physiology | Bonn | North Rhine-Westphalia | 53113 | Germany |
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| control diet based on Western Diet low in legumes | Other | diet based on the Western dietary pattern including animal protein sources (= control diet) |
|
| postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention |
| Parameters of glucose metabolism in blood | Glucagon (pg/mL) | postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention |
| Parameters of glucose metabolism in blood | HbA1c (%) | Fasting (t=0) in week 1 and week 6 of intervention |
| Parameters of glucose metabolism in blood | Fructosamine (µmol/l) | Fasting (t=0) in week 1 and week 6 of intervention |
| Parameters of lipid metabolism in blood | Triglycerides (mg/dL) | Fasting (t=0) in week 1 and week 6 of intervention |
| Parameters of lipid metabolism in blood | Total cholesterol (mg/dL) | Fasting (t=0) in week 1 and week 6 of intervention |
| Parameters of lipid metabolism in blood | LDL cholesterol (mg/dL) | Fasting (t=0) in week 1 and week 6 of intervention |
| Parameters of lipid metabolism in blood | HDL cholesterol (mg/dL) | Fasting (t=0) in week 1 and week 6 of intervention |
| Parameters of lipid metabolism in blood | Free fatty acids (mmol/L) | Fasting (t=0) in week 1 and week 6 of intervention |
| Parameters of lipid metabolism in blood | Lipoprotein(a) (mg/dL/nmol/L) | Fasting (t=0) in week 1 and week 6 of intervention |
| Parameters of lipid metabolism in blood | Apo A1 (g/L) | Fasting (t=0) in week 1 and week 6 of intervention |
| Parameters of lipid metabolism in blood | Apo B (g/L) | Fasting (t=0) in week 1 and week 6 of intervention |
| Parameters of lipid metabolism in blood | Fatty acid composition of serum phospholipids | Fasting (t=0) in week 1 and week 6 of intervention |
| Blood urea | Urea in blood (mg/dL) | Fasting (t=0) in week 1 and week 6 of intervention |
| Uric acid in blood | Uric acid in blood (mg/dL) | Fasting (t=0) in week 1 and week 6 of intervention |
| Parameters of endothelial function in blood | ADMA (µmo/L) | Fasting (t=0) in week 1 and week 6 of intervention |
| Parameters of inflammation in blood | IL-6 (pg/mL) | Fasting (t=0) in week 1 and week 6 of intervention |
| Parameters of Hunger and Satiety in blood | Ghrelin (pg/mL) | Fasting (t=0) in week 1 and week 6 of intervention |
| Endothelial function | pulse wave velocity (m/s) with the vicorder device | Fasting (t=0) in week 1 and week 6 of intervention |
| Liver enzymes | GGT (U/L) | Fasting (t=0) in week 1 and week 6 of intervention |
| Liver enzymes | ALT (U/L) | Fasting (t=0) in week 1 and week 6 of intervention |
| Liver enzymes | AST (U/L) | 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 | Ferritin (µg/L) | Fasting (t=0) in week 1 and week 6 of intervention |
| Adiponectin | Adiponectin (µg/ml) | Fasting (t=0) in week 1 and week 6 of intervention |
| Parameters oft the antioxidant system | vitamin C | Fasting (t=0) in week 1 and week 6 of intervention |
| Parameters oft the antioxidant system | vitamin E | Fasting (t=0) in week 1 and week 6 of intervention |
| Parameters oft the antioxidant system | ß-carotine | Fasting (t=0) in week 1 and week 6 of intervention |
| Parameters oft the antioxidant system | B vitamins | Fasting (t=0) in week 1 and week 6 of intervention |
| trace elements | iron | Fasting (t=0) in week 1 and week 6 of intervention |
| trace elements | cupper | Fasting (t=0) in week 1 and week 6 of intervention |
| trace elements | zinc | Fasting (t=0) in week 1 and week 6 of intervention |
| trace elements | selen | 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 | GFAP | Fasting (t=0) in week 1 and week 6 of intervention |
| Neurodegenerative markers | Aβ42 | Fasting (t=0) in week 1 and week 6 of intervention |
| Neurodegenerative markers | Aβ40 | Fasting (t=0) in week 1 and week 6 of intervention |
| Neurodegenerative markers | NF-L | Fasting (t=0) in week 1 and week 6 of intervention |
| Blood pressure | Blood pressure (mmHg) | Fasting (t=0) in week 1 and week 6 of intervention |
| REE | REE (kcal/24h) | Fasting (t=0) in week 1 and week 6 of intervention |
| Anthropometic measurements | weight (kg) | Fasting (t=0) in week 1 and week 6 of intervention |
| Anthropometic measurements | fat mass (%) | Fasting (t=0) in week 1 and week 6 of intervention |
| Anthropometic measurements | waist circumference (cm) | Fasting (t=0) in week 1 and week 6 of intervention |
| Neuropsychological parameters | Assessment of memory via a validated neuropsychological questionaire (paper pencil, e.g. higher reproduction of memorised visual and verbal information = better memory; visual part: maximum points: 31 = all visual information memorised, minimum points: 0 = no visual information memorised; verbal part: maximum points: 24 = all verbal information memorised, minimum points: 0 = no verbal information memorised) | 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 |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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