Institute of Nutritional and Food Sciences, Nutrition Physiology
Bonn, North Rhine-Westphalia, 53113, Germany
NCT Number: NCT06700954
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.
Trial opening soon.
Get Notified50 year–75 year
All sexes
Interventional
Not applicable
Bonn, North Rhine-Westphalia, 53113, Germany
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention
Glucose (mg/dL)
Time frame: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention
Insulin (nmol/L)
Time frame: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention
GLP-1 (pg/mL)
Time frame: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention
Glucagon (pg/mL)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
HbA1c (%)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Fructosamine (µmol/l)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Triglycerides (mg/dL)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Total cholesterol (mg/dL)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
LDL cholesterol (mg/dL)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
HDL cholesterol (mg/dL)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Free fatty acids (mmol/L)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Lipoprotein(a) (mg/dL/nmol/L)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Apo A1 (g/L)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Apo B (g/L)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Fatty acid composition of serum phospholipids
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Urea in blood (mg/dL)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Uric acid in blood (mg/dL)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
ADMA (µmo/L)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
IL-6 (pg/mL)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Ghrelin (pg/mL)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
pulse wave velocity (m/s) with the vicorder device
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
GGT (U/L)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
ALT (U/L)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
AST (U/L)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Ferritin (µg/L)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Adiponectin (µg/ml)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
vitamin C
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
vitamin E
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
ß-carotine
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
B vitamins
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
iron
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
cupper
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
zinc
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
selen
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
GFAP
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Aβ42
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Aβ40
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
NF-L
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Blood pressure (mmHg)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
REE (kcal/24h)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
weight (kg)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
fat mass (%)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
waist circumference (cm)
Time frame: 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)
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Contact information is provided by the study sponsor or research team.
University of Bonn
Other
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
Acronym: LeguPlan_2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07394049
Cardiovascular Diseases, Hormone Replacement Therapy
Berlin, Germany
View Trial DetailsNCT07727135
Acute Coronary Syndrome, Angina Pectoris
Aalborg, Denmark
View Trial DetailsNCT07721584
Arterial Occlusive Diseases, Arteriosclerosis
View Trial DetailsNCT07721649
Acute Coronary Syndrome, Behavior
Cologne, Germany
View Trial Details