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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-75
SponsorUniversity of Bonn

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

written informed consent

Non-smoking

BMI: 27 - 34,9 kg/m2

Waist circumference (women ≥ 80 cm, men ≥ 94 cm)

Disqualifiers

food intolerances and allergies (especially legumes)

Smoking

malabsorption syndromes

thyroid diseases

Trial design

Design model

Parallel

Treatments tested in this trial

  • legume-rich Planetary Health Diet

    Other intervention

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

  • control diet based on Western Diet low in legumes

    Other intervention

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: legume-rich Planetary Health DietExperimental treatment 1 intervention
Group B: control diet based on Western Diet low in legumesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pameters of glucose metabolism in blood

Glucose (mg/dL)

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

Secondary outcomes

1

Parameters of glucose metabolism in blood

Insulin (nmol/L)

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

Parameters of glucose metabolism in blood

GLP-1 (pg/mL)

Time frame
postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention
3

Parameters of glucose metabolism in blood

Glucagon (pg/mL)

Time frame
postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention
4

Parameters of glucose metabolism in blood

HbA1c (%)

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

Other outcomes

Sponsors and contacts

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University of Bonn

Lead sponsor

Federal Ministry of Food and Agriculture (BMEL)

Collaborator

Federal Office of Agriculture and Food (BLE)

Collaborator

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