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 | Not Yet Recruiting

• 1 other identifier: BMEL: 2822EPS008 2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Pameters of glucose metabolism in blood

  Glucose (mg/dL)

  postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention

Secondary Outcomes (46)

• Parameters of glucose metabolism in blood

  postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention

• Parameters of glucose metabolism in blood

  postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention

• Parameters of glucose metabolism in blood

  postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention

• Parameters of glucose metabolism in blood

  Fasting (t=0) in week 1 and week 6 of intervention

• Parameters of glucose metabolism in blood

  Fasting (t=0) in week 1 and week 6 of intervention

Study Arms (2)

legume-rich Planetary Health Diet

EXPERIMENTAL

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

Other: legume-rich Planetary Health Diet

control diet based on Western Diet low in legumes

EXPERIMENTAL

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

Other: control diet based on Western Diet low in legumes

Interventions

legume-rich Planetary Health Diet OTHER

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

legume-rich Planetary Health Diet

control diet based on Western Diet low in legumes OTHER

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

control diet based on Western Diet low in legumes

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bonn: lead
• Federal Ministry of Food and Agriculture (BMEL): collaborator
• Federal Office of Agriculture and Food (BLE): collaborator

Study Sites (1)

Institute of Nutritional and Food Sciences, Nutrition Physiology

Bonn, North Rhine-Westphalia, 53113, Germany

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Sarah Egert, Prof PhD

CONTACT

+ 49 (0) 228 / 73 59 53; s.egert@uni-bonn.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Sarah Egert

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 22, 2024
• Study Start: January 6, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Locations

DE (1)