NCT06700954

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Bonn · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
OTHER	legume-rich Planetary Health Diet	legume-rich diet based on the Planetary Health Diet, with a focus on vegetable protein
OTHER	control diet based on Western Diet low in legumes	diet based on the Western dietary pattern including animal protein sources (= control diet)

Timeline

• Start date: 2025-01-06
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-11-22
• Last updated: 2024-11-22

Locations

1 site across 1 country: Germany