Effects of a Legume-rich Diet in the Context of the Planetary Health Diet Compared to a Western-oriented Dietary Pattern in Participants with Increased Cardiometabolic Risk
- Conditions
- Cardiovascular Diseases
- Registration Number
- NCT06700954
- Lead Sponsor
- University of Bonn
- 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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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 exclusion criteria at the discretion of the physician/ investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Parameters of glucose metabolism in blood Fasting (t=0) in week 1 and week 6 of intervention Fructosamine (µmol/l)
Parameters of lipid metabolism in blood Fasting (t=0) in week 1 and week 6 of intervention Fatty acid composition of serum phospholipids
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 AST (U/L)
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 Ferritin (µg/L)
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 B vitamins
trace elements Fasting (t=0) in week 1 and week 6 of intervention selen
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 NF-L
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 waist circumference (cm)
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
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Trial Locations
- Locations (1)
Institute of Nutritional and Food Sciences, Nutrition Physiology
🇩🇪Bonn, North-Rhine Westphalia, Germany