Acute Effects of Legume-enriched Meals Compared to Western Diet Meals on Postprandial Metabolism in Participants with Increased Cardiometabolic Risk (LeguPlan_1)

University of Bonn

Status: Completed

Conditions: Cardiovascular Diseases; Metabolic Syndrome

Treatments: Other: High Protein Western Diet; Other: Low Protein Western Diet; Other: High Protein Planetary Health Diet; Other: Low Protein Planetary Health Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06270901

BMEL: 2822EPS008

Details and patient eligibility

About

The aim of the study is to investigate the postprandial effects of legume-enriched meals compared to Western Diet meals on postprandial metabolism. In this context, older adults with increased risk for cardiometabolic diseases consume 4 mixed meals with 36 g or 62 g of protein either designed according to the Planetary Health Diet with legumes as primary protein source or the Western Diet with animal foods as primary protein source, in a randomized order. In a postprandial observation period of 6 hours, parameters of lipid metabolism, glucose and insulin metabolism, amino acid profile, as well as markers of inflammation and vascular function are analysed. Furthermore, neuropsychological parameters and satiety-associated hormones are investigated.

Full description

In a randomized crossover design, 30 older men and women with increased risk for cardiometabolic diseases consume 4 mixed meals, which differ in dietary pattern, protein source and protein quantity. Two meals are designed according to the Planetary Health Diet with legumes as primary protein source whereas the other two meals are designed according to the Western Diet with animal food as primary protein source. Two meals are designed as high protein meals (62 g of protein) and two meals are designed as low protein meals (36 g of Protein). Therefore, participants consume 4 different test meals, a Low and a High Protein Western Diet Meal and a Low and a High Protein Planetary Health Diet Meal in a randomized order. During a postprandial observation period of 6 hours, parameters of lipid metabolism (e.g., plasma triglycerides), glucose metabolism (e.g., plasma glucose, serum insulin), as well as markers of inflammation (e.g., IL-6) and vascular function (e.g., pulse wave velocity) are analysed. Furthermore, amino acid profile, neuropsychologic parameters (e.g., appetite) and satiety-associated hormones (e.g., Ghrelin) are investigated. Each intervention will be separated by a washout period of approximately 14 days.

Enrollment: 30 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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 HDL-Cholesterol in serum: women < 50 mg/dl, men < 40 mg/dL
• Fasting C-reactive protein in serum: ≥ 2 mg/L
• Fasting glucose in plasma: ≥ 100 mg/dL

Exclusion criteria

• food intolerances and allergies (especially to 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 4 patient groups

High Protein Planetary Health Diet

Experimental group

Description:

High Protein Planetary Health Diet Meal: This meal contains 62 g of protein primarily from plant origin (particularly legumes)

Treatment:

Other: High Protein Planetary Health Diet

Low Protein Planetary Health Diet

Experimental group

Description:

Low Protein Planetary Health Diet Meal: This meal contains 36 g of protein from primarily plant origin (particularly legumes)

Treatment:

Other: Low Protein Planetary Health Diet

High Protein Western Diet

Experimental group

Description:

High Protein Western Diet Meal: This meal contains 62 g of protein primarily form animal origin

Treatment:

Other: High Protein Western Diet

Low Protein Western Diet

Experimental group

Description:

Low Protein Western Diet Meal: This meal contains 36 g of protein primarily from animal origin

Treatment:

Other: Low Protein Western Diet