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

University of Bonn30 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

Interventions

High Protein Planetary Health DietOTHER

Planetary Health Diet Meal with 62 g of protein primarily from plant origin

Low Protein Planetary Health DietOTHER

Planetary Health Diet Meal with 36 g of protein primarily from plant origin

High Protein Western DietOTHER

Western Diet Meal with 62 g of protein primarily from animal origin

Low Protein Western DietOTHER

Western Diet Meal with 36 g of protein primarily from animal origin

Eligibility

Sex: ALLMin age: 50 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Parameters of lipid metabolism in blood

Triglycerides (mg/dL)

Time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)

Secondary Outcomes

Parameters of lipid metabolism in blood

Total cholesterol (mg/dL)

Time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)

Parameters of lipid metabolism in blood

LDL cholesterol (mg/dL)

Time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)

Parameters of lipid metabolism in blood

HDL cholesterol (mg/dL)

Time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)

Parameters of lipid metabolism in blood

Free fatty acids (mmol/L)

Time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)

Parameters of glucose metabolism in blood

Glucose (mg/dL)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)

Parameters of glucose metabolism in blood

Glucagon (pg/mL)

Time frame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)

Blood amino acid profile

Amino acid profile in blood (nmol/mL)

Time frame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)

Blood urea

Urea in blood (mg/dL)

Time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)

Uric acid in blood

Uric acid in blood (mg/dL)

Time frame: 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)

Time frame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)

Parameters of endothelial function in blood

e.g. ADMA (µmo/L)

Time frame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)

Parameters of inflammation in blood

e.g. IL-6 (pg/mL)

Time frame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)

Endothelial function

e.g. pulse wave velocity (m/s)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: Postprandial period of 6 hours (T=0.5, 3, 6 hours)

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes