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

Acute Effects of Legume-enriched Meals Compared to Western Diet Meals on Postprandial Metabolic Response in Women and Men at Increased Risk of Cardiovascular and Neurodegenerative Diseases

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Metabolic Syndrome
• Intervention / Treatment: Other: High Protein Planetary Health Diet; Other: Low Protein Planetary Health Diet; Other: High Protein Western Diet; Other: Low Protein Western Diet

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • North-Rhine Westphalia
    • Bonn, North-Rhine Westphalia, Germany, 53115
      • Recruiting
      • University of Bonn, Institute of Nutritional and Food Sciences, Nutrition Physiology
      • Contact: Sarah Egert, Prof. Dr.; Phone Number: + 49 (0) 228 / 73 59; 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 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Protein Planetary Health Diet; High Protein Planetary Health Diet Meal: This meal contains 62 g of protein primarily from plant origin (particularly legumes)	Other: High Protein Planetary Health Diet; Planetary Health Diet Meal with 62 g of protein primarily from plant origin
Experimental: Low Protein Planetary Health Diet; Low Protein Planetary Health Diet Meal: This meal contains 36 g of protein from primarily plant origin (particularly legumes)	Other: Low Protein Planetary Health Diet; Planetary Health Diet Meal with 36 g of protein primarily from plant origin
Experimental: High Protein Western Diet; High Protein Western Diet Meal: This meal contains 62 g of protein primarily form animal origin	Other: High Protein Western Diet; Western Diet Meal with 62 g of protein primarily from animal origin
Experimental: Low Protein Western Diet; Low Protein Western Diet Meal: This meal contains 36 g of protein primarily from animal origin	Other: Low Protein Western Diet; Western Diet Meal with 36 g of protein primarily from animal origin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parameters of lipid metabolism in blood	Total cholesterol (mg/dL)	Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Parameters of lipid metabolism in blood	LDL cholesterol (mg/dL)	Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Parameters of lipid metabolism in blood	HDL cholesterol (mg/dL)	Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Parameters of lipid metabolism in blood	Free fatty acids (mmol/L)	Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Parameters of glucose metabolism in blood	Glucose (mg/dL)	Postprandial period of 6 hours (T=0, 0.5, 1, 1.5, 2, 3, 4, 6 hours)
Parameters of glucose metabolism in blood	Insulin (nmol/L)	Postprandial period of 6 hours (T=0, 0.5, 1, 1.5, 2, 3, 4, 6 hours)
Parameters of glucose metabolism in blood	cPeptide (pg/mL)	Postprandial period of 6 hours (T=0, 0.5, 1, 1.5, 2, 3, 4, 6 hours)
Parameters of glucose metabolism in blood	GLP-1 (pg/mL)	Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
Parameters of glucose metabolism in blood	Glucagon (pg/mL)	Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
Blood amino acid profile	Amino acid profile in blood (nmol/mL)	Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
Blood urea	Urea in blood (mg/dL)	Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Uric acid in blood	Uric acid in blood (mg/dL)	Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Parameters of hunger and satiety in blood	e.g. Ghrelin (pg/mL)	Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
Parameters of endothelial function in blood	e.g. ADMA (µmo/L)	Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
Parameters of inflammation in blood	e.g. IL-6 (pg/mL)	Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
Endothelial function	e.g. pulse wave velocity (m/s)	Postprandial period of 6 hours (T=0, 2, 4, 6 hours)
Neuropsychological parameters	Assessment of hunger and satiety via a visual analogue scale (e.g. 0 = not hungry at all to 10 = very hungry)	Postprandial period of 6 hours (T=0, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours)
Neuropsychological parameters	Assessment of attention via questionnaire (paper pencil test, e.g. higher amount of marked target items = higher attention, maximum points 640 = every target items marked correctly, minimum points: 0 = no target items marked or only wrong items marked)	Postprandial period of 4.5 hours (T= 0, 1.5, 3, 4.5 hours)
Neuropsychological parameters	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)	Postprandial period of 6 hours (T=0.5, 3, 6 hours)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): July 30, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: February 2, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Actual): February 21, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: postprandial metabolic events
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Cardiovascular Diseases; Metabolic Syndrome
• Other Study ID Numbers: BMEL: 2822EPS008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No