Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: University of Bonn
Sponsor class: OTHER
Collaborators: name: Federal Ministry of Food and Agriculture (BMEL)
name: Federal Office of Agriculture and Food (BLE)
First posted: 2024-11-22
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).

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
* other exclusion criteria at the discretion of the physician/ investigator

Primary outcomes:
measure: Pameters of glucose metabolism in blood
timeFrame: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention
Secondary outcomes:
measure: Parameters of glucose metabolism in blood
timeFrame: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention
measure: Parameters of glucose metabolism in blood
timeFrame: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention
measure: Parameters of glucose metabolism in blood
timeFrame: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention
measure: Parameters of glucose metabolism in blood
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Parameters of glucose metabolism in blood
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Parameters of lipid metabolism in blood
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Parameters of lipid metabolism in blood
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Parameters of lipid metabolism in blood
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Parameters of lipid metabolism in blood
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Parameters of lipid metabolism in blood
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Parameters of lipid metabolism in blood
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Parameters of lipid metabolism in blood
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Parameters of lipid metabolism in blood
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Parameters of lipid metabolism in blood
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Blood urea
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Uric acid in blood
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Parameters of endothelial function in blood
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Parameters of inflammation in blood
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Parameters of Hunger and Satiety in blood
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Endothelial function
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Liver enzymes
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Liver enzymes
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Liver enzymes
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Small blood count
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Ferritin
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Adiponectin
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Parameters oft the antioxidant system
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Parameters oft the antioxidant system
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Parameters oft the antioxidant system
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Parameters oft the antioxidant system
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: trace elements
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: trace elements
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: trace elements
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: trace elements
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Proteomics
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Neurodegenerative markers
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Neurodegenerative markers
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Neurodegenerative markers
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Neurodegenerative markers
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Blood pressure
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: REE
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Anthropometic measurements
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Anthropometic measurements
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Anthropometic measurements
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Neuropsychological parameters
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
measure: Fecal fatty acid profile
timeFrame: Fasting (t=0) in week 1 and week 6 of intervention
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Institute of Nutritional and Food Sciences, Nutrition Physiology
state: North-Rhine Westphalia
Study officials:
References: