Cardiovascular Diseases
Conditions
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).
Interventions
OTHERlegume-rich Planetary Health Diet
legume-rich diet based on the Planetary Health Diet, with a focus on vegetable protein
OTHERcontrol diet based on Western Diet low in legumes
diet based on the Western dietary pattern including animal protein sources (= control diet)
Sponsors
Federal Ministry of Food and Agriculture (BMEL)
Federal Office of Agriculture and Food (BLE)
University of Bonn
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
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 * CRP in serum 0,2-3 mg/dL
Exclusion criteria
* food intolerances and allergies (especially legumes) * Smoking * malabsorption syndromes * thyroid diseases * impaired renal function * chronic liver disease * heart failure * myocardial infarction * insulin-dependent diabetes mellitus * chronic inflammatory diseases * tumors * anemia * immunosuppression * intake of supplements (e.g., fish oil) * Participation in another study * other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pameters of glucose metabolism in blood | postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention | Glucose (mg/dL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parameters of glucose metabolism in blood | postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention | Insulin (nmol/L) |
| Parameters of lipid metabolism in blood | Fasting (t=0) in week 1 and week 6 of intervention | Triglycerides (mg/dL) |
| Blood urea | Fasting (t=0) in week 1 and week 6 of intervention | Urea in blood (mg/dL) |
| Uric acid in blood | Fasting (t=0) in week 1 and week 6 of intervention | Uric acid in blood (mg/dL) |
| Parameters of endothelial function in blood | Fasting (t=0) in week 1 and week 6 of intervention | ADMA (µmo/L) |
| Parameters of inflammation in blood | Fasting (t=0) in week 1 and week 6 of intervention | IL-6 (pg/mL) |
| Parameters of Hunger and Satiety in blood | Fasting (t=0) in week 1 and week 6 of intervention | Ghrelin (pg/mL) |
| Endothelial function | Fasting (t=0) in week 1 and week 6 of intervention | pulse wave velocity (m/s) with the vicorder device |
| Liver enzymes | Fasting (t=0) in week 1 and week 6 of intervention | GGT (U/L) |
| Small blood count | Fasting (t=0) in week 1 and week 6 of intervention | — |
| Proteomics | Fasting (t=0) in week 1 and week 6 of intervention | — |
| Adiponectin | Fasting (t=0) in week 1 and week 6 of intervention | Adiponectin (µg/ml) |
| Parameters oft the antioxidant system | Fasting (t=0) in week 1 and week 6 of intervention | vitamin C |
| trace elements | Fasting (t=0) in week 1 and week 6 of intervention | iron |
| Neurodegenerative markers | Fasting (t=0) in week 1 and week 6 of intervention | GFAP |
| Blood pressure | Fasting (t=0) in week 1 and week 6 of intervention | Blood pressure (mmHg) |
| REE | Fasting (t=0) in week 1 and week 6 of intervention | REE (kcal/24h) |
| Anthropometic measurements | Fasting (t=0) in week 1 and week 6 of intervention | weight (kg) |
| Neuropsychological parameters | Fasting (t=0) in week 1 and week 6 of intervention | 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) |
| Fecal fatty acid profile | Fasting (t=0) in week 1 and week 6 of intervention | — |
| Ferritin | Fasting (t=0) in week 1 and week 6 of intervention | Ferritin (µg/L) |
Countries
Germany
Contacts
Primary ContactSarah Egert, Prof PhD
Outcome results
None listed