An interventional study of legume-rich Planetary Health Diet and control diet based on Western Diet low in legumes in Cardiovascular Diseases, sponsored by University of Bonn. Not yet recruiting at 1 site in Germany. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-22.
Sponsored by University of Bonn · Not applicable, Interventional, and Basic science
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).
5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →University of Bonn is the lead sponsor of 39 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
legume-rich diet based on the Planetary Health Diet, with a focus on vegetable protein
Other: legume-rich Planetary Health Diet
diet based on the Western dietary pattern including animal protein sources (= control diet)
Other: control diet based on Western Diet low in legumes
legume-rich diet based on the Planetary Health Diet, with a focus on vegetable protein
diet based on the Western dietary pattern including animal protein sources (= control diet)
Pameters of glucose metabolism in blood
Glucose (mg/dL)
Time frame: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention
Parameters of glucose metabolism in blood
Insulin (nmol/L)
Time frame: 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)
Time frame: 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)
Time frame: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention
Parameters of glucose metabolism in blood
HbA1c (%)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of glucose metabolism in blood
Fructosamine (µmol/l)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
Triglycerides (mg/dL)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
Total cholesterol (mg/dL)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
LDL cholesterol (mg/dL)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
HDL cholesterol (mg/dL)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
Free fatty acids (mmol/L)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
Lipoprotein(a) (mg/dL/nmol/L)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
Apo A1 (g/L)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
Apo B (g/L)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
Fatty acid composition of serum phospholipids
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Blood urea
Urea in blood (mg/dL)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Uric acid in blood
Uric acid in blood (mg/dL)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of endothelial function in blood
ADMA (µmo/L)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of inflammation in blood
IL-6 (pg/mL)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of Hunger and Satiety in blood
Ghrelin (pg/mL)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Endothelial function
pulse wave velocity (m/s) with the vicorder device
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Liver enzymes
GGT (U/L)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Liver enzymes
ALT (U/L)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Liver enzymes
AST (U/L)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Small blood count
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Ferritin
Ferritin (µg/L)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Adiponectin
Adiponectin (µg/ml)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters oft the antioxidant system
vitamin C
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters oft the antioxidant system
vitamin E
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters oft the antioxidant system
ß-carotine
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters oft the antioxidant system
B vitamins
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
trace elements
iron
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
trace elements
cupper
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
trace elements
zinc
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
trace elements
selen
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Proteomics
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Neurodegenerative markers
GFAP
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Neurodegenerative markers
Aβ42
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Neurodegenerative markers
Aβ40
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Neurodegenerative markers
NF-L
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Blood pressure
Blood pressure (mmHg)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
REE
REE (kcal/24h)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Anthropometic measurements
weight (kg)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Anthropometic measurements
fat mass (%)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Anthropometic measurements
waist circumference (cm)
Time frame: 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)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Fecal fatty acid profile
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Bonn