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 (LeguPlan_2)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Other: legume-rich Planetary Health Diet; Other: control diet based on Western Diet low in legumes

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).

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Egert, Prof PhD; Phone Number: + 49 (0) 228 / 73 59 53; Email: s.egert@uni-bonn.de

Study Locations

• Germany
  • North-Rhine Westphalia
    • Bonn, North-Rhine Westphalia, Germany, 53113
      • Institute of Nutritional and Food Sciences, Nutrition Physiology
      • Contact: Sarah Egert, Prof PhD; Phone Number: + 49 (0) 228/73 59 53; Email: s.egert@uni-bonn.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: legume-rich Planetary Health Diet; legume-rich diet based on the Planetary Health Diet, with a focus on vegetable protein	Other: legume-rich Planetary Health Diet; legume-rich diet based on the Planetary Health Diet, with a focus on vegetable protein
Experimental: control diet based on Western Diet low in legumes; diet based on the Western dietary pattern including animal protein sources (= control diet)	Other: control diet based on Western Diet low in legumes; diet based on the Western dietary pattern including animal protein sources (= control diet)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parameters of glucose metabolism in blood	Insulin (nmol/L)	postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention
Parameters of glucose metabolism in blood	GLP-1 (pg/mL)	postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention
Parameters of glucose metabolism in blood	Glucagon (pg/mL)	postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention
Parameters of glucose metabolism in blood	HbA1c (%)	Fasting (t=0) in week 1 and week 6 of intervention
Parameters of glucose metabolism in blood	Fructosamine (µmol/l)	Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood	Triglycerides (mg/dL)	Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood	Total cholesterol (mg/dL)	Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood	LDL cholesterol (mg/dL)	Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood	HDL cholesterol (mg/dL)	Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood	Free fatty acids (mmol/L)	Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood	Lipoprotein(a) (mg/dL/nmol/L)	Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood	Apo A1 (g/L)	Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood	Apo B (g/L)	Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood	Fatty acid composition of serum phospholipids	Fasting (t=0) in week 1 and week 6 of intervention
Blood urea	Urea in blood (mg/dL)	Fasting (t=0) in week 1 and week 6 of intervention
Uric acid in blood	Uric acid in blood (mg/dL)	Fasting (t=0) in week 1 and week 6 of intervention
Parameters of endothelial function in blood	ADMA (µmo/L)	Fasting (t=0) in week 1 and week 6 of intervention
Parameters of inflammation in blood	IL-6 (pg/mL)	Fasting (t=0) in week 1 and week 6 of intervention
Parameters of Hunger and Satiety in blood	Ghrelin (pg/mL)	Fasting (t=0) in week 1 and week 6 of intervention
Endothelial function	pulse wave velocity (m/s) with the vicorder device	Fasting (t=0) in week 1 and week 6 of intervention
Liver enzymes	GGT (U/L)	Fasting (t=0) in week 1 and week 6 of intervention
Liver enzymes	ALT (U/L)	Fasting (t=0) in week 1 and week 6 of intervention
Liver enzymes	AST (U/L)	Fasting (t=0) in week 1 and week 6 of intervention
Small blood count		Fasting (t=0) in week 1 and week 6 of intervention
Ferritin	Ferritin (µg/L)	Fasting (t=0) in week 1 and week 6 of intervention
Adiponectin	Adiponectin (µg/ml)	Fasting (t=0) in week 1 and week 6 of intervention
Parameters oft the antioxidant system	vitamin C	Fasting (t=0) in week 1 and week 6 of intervention
Parameters oft the antioxidant system	vitamin E	Fasting (t=0) in week 1 and week 6 of intervention
Parameters oft the antioxidant system	ß-carotine	Fasting (t=0) in week 1 and week 6 of intervention
Parameters oft the antioxidant system	B vitamins	Fasting (t=0) in week 1 and week 6 of intervention
trace elements	iron	Fasting (t=0) in week 1 and week 6 of intervention
trace elements	cupper	Fasting (t=0) in week 1 and week 6 of intervention
trace elements	zinc	Fasting (t=0) in week 1 and week 6 of intervention
trace elements	selen	Fasting (t=0) in week 1 and week 6 of intervention
Proteomics		Fasting (t=0) in week 1 and week 6 of intervention
Neurodegenerative markers	GFAP	Fasting (t=0) in week 1 and week 6 of intervention
Neurodegenerative markers	Aβ42	Fasting (t=0) in week 1 and week 6 of intervention
Neurodegenerative markers	Aβ40	Fasting (t=0) in week 1 and week 6 of intervention
Neurodegenerative markers	NF-L	Fasting (t=0) in week 1 and week 6 of intervention
Blood pressure	Blood pressure (mmHg)	Fasting (t=0) in week 1 and week 6 of intervention
REE	REE (kcal/24h)	Fasting (t=0) in week 1 and week 6 of intervention
Anthropometic measurements	weight (kg)	Fasting (t=0) in week 1 and week 6 of intervention
Anthropometic measurements	fat mass (%)	Fasting (t=0) in week 1 and week 6 of intervention
Anthropometic measurements	waist circumference (cm)	Fasting (t=0) in week 1 and week 6 of intervention
Neuropsychological parameters	Assessment of memory via a validated neuropsychological questionaire (paper pencil, e.g. higher reproduction of memorised visual and verbal information = better memory; visual part: maximum points: 31 = all visual information memorised, minimum points: 0 = no visual information memorised; verbal part: maximum points: 24 = all verbal information memorised, minimum points: 0 = no verbal information memorised)	Fasting (t=0) in week 1 and week 6 of intervention
Fecal fatty acid profile		Fasting (t=0) in week 1 and week 6 of intervention

Collaborators and Investigators

• Sponsor: University of Bonn
• Collaborators: Federal Ministry of Food and Agriculture (BMEL); Federal Office of Agriculture and Food (BLE)

Study record dates

Study Major Dates

• Study Start (Estimated): January 6, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 19, 2024
• First Posted (Estimated): November 22, 2024

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: BMEL: 2822EPS008 2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No