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

NCT06700954 · tracked via the Priya Life Science Germany tracker

Sponsor

University of Bonn

Phase

Not applicable

Started

2025-01-06

Last updated

2024-11-22

Condition(s) studied

Cardiovascular Diseases

Investigational drug(s) / intervention(s)

legume-rich Planetary Health Dietcontrol diet based on Western Diet low in legumes

legume-rich Planetary Health Diet: legume-rich diet based on the Planetary Health Diet, with a focus on vegetable protein

control diet based on Western Diet low in legumes: diet based on the Western dietary pattern including animal protein sources (= control diet)

Study 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.

Eligibility

Sex

ALL

Min age

50 Years

Max age

75 Years

Healthy volunteers

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 exclusion criteria at the discretion of the physician/ investigator

Primary outcome measure(s)

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)

Trial sites (1)

Facility	City	Region	Status
Institute of Nutritional and Food Sciences, Nutrition Physiology	Bonn	North Rhine-Westphalia

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06700954 on ClinicalTrials.gov ↗ ← All trials in Germany