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

Not Applicable

Completed

• Conditions: Metabolic Syndrome; Cardiovascular Diseases
• Interventions: Other: High Protein Planetary Health Diet; Other: Low Protein Planetary Health Diet; Other: High Protein Western Diet; Other: Low Protein Western Diet

• Registration Number: NCT06270901
• Lead Sponsor: University of Bonn

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-02-02
• Study First Submitted QC: 2024-02-13
• Study First Posted: 2024-02-21
• Status Verified: 2024-05
• Study Start: 2024-05-02
• Primary Completion: 2024-09-11
• Study Completion: 2024-09-11
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High Protein Planetary Health Diet	High Protein Planetary Health Diet	High Protein Planetary Health Diet Meal: This meal contains 62 g of protein primarily from plant origin (particularly legumes)
Low Protein Planetary Health Diet	Low Protein Planetary Health Diet	Low Protein Planetary Health Diet Meal: This meal contains 36 g of protein from primarily plant origin (particularly legumes)
High Protein Western Diet	High Protein Western Diet	High Protein Western Diet Meal: This meal contains 62 g of protein primarily form animal origin
Low Protein Western Diet	Low Protein Western Diet	Low Protein Western Diet Meal: This meal contains 36 g of protein primarily from animal origin

Primary Outcome Measures

Name	Time	Method
Parameters of lipid metabolism in blood	Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)	Triglycerides (mg/dL)

Secondary Outcome Measures

Name	Time	Method
Parameters of endothelial function in blood	Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)	e.g. ADMA (µmo/L)
Parameters of lipid metabolism in blood	Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)	Free fatty acids (mmol/L)
Blood urea	Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)	Urea in blood (mg/dL)
Endothelial function	Postprandial period of 6 hours (T=0, 2, 4, 6 hours)	e.g. pulse wave velocity (m/s)
Parameters of glucose metabolism in blood	Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)	Glucagon (pg/mL)
Parameters of hunger and satiety in blood	Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)	e.g. Ghrelin (pg/mL)
Blood amino acid profile	Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)	Amino acid profile in blood (nmol/mL)
Uric acid in blood	Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)	Uric acid in blood (mg/dL)
Parameters of inflammation in blood	Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)	e.g. IL-6 (pg/mL)
Neuropsychological parameters	Postprandial period of 6 hours (T=0.5, 3, 6 hours)	Assessment of memory via questionnaire (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)

Trial Locations

Locations (1)

University of Bonn, Institute of Nutritional and Food Sciences, Nutrition Physiology; 🇩🇪 Bonn, North-Rhine Westphalia, Germany