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

NCT ID: NCT06700954

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-06
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

legume-rich Planetary Health Diet

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

Group Type: EXPERIMENTAL

legume-rich Planetary Health Diet

Intervention Type: OTHER

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)

Group Type: EXPERIMENTAL

control diet based on Western Diet low in legumes

Intervention Type: OTHER

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

Interventions

legume-rich Planetary Health Diet

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

Intervention Type: OTHER

control diet based on Western Diet low in legumes

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal Ministry of Food and Agriculture (BMEL)

UNKNOWN

Sponsor Role: collaborator

Federal Office of Agriculture and Food (BLE)

UNKNOWN

Sponsor Role: collaborator

University of Bonn

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Sarah Egert

Prof. Dr. Sarah Egert

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institute of Nutritional and Food Sciences, Nutrition Physiology

Bonn, North Rhine-Westphalia, Germany

Countries

Germany

Central Contacts

Sarah Egert, Prof PhD

Role: CONTACT

s.egert@uni-bonn.de

+ 49 (0) 228 / 73 59 53

Facility Contacts

Sarah Egert, Prof PhD

Role: primary

s.egert@uni-bonn.de

+ 49 (0) 228/73 59 53

Other Identifiers

BMEL: 2822EPS008 2

Identifier Type: -

Identifier Source: org_study_id