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 (LeguPlan_2)

University of Bonn

Status: Not yet enrolling

Conditions: Cardiovascular Diseases

Treatments: Other: control diet based on Western Diet low in legumes; Other: legume-rich Planetary Health Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06700954

BMEL: 2822EPS008 2

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

legume-rich Planetary Health Diet

Experimental group

Description:

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

Treatment:

Other: legume-rich Planetary Health Diet

control diet based on Western Diet low in legumes

Experimental group

Description:

diet based on the Western dietary pattern including animal protein sources (= control diet)

Treatment:

Other: control diet based on Western Diet low in legumes