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

Cardiovascular Diseases Clinical Trial

— LeguPlan_1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06270901
• Other study ID #: BMEL: 2822EPS008
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2024
• Est. completion date: July 30, 2024

Study information

• Verified date: May 2024
• Source: University of Bonn
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Metabolic Syndrome

Intervention

Other:
• High Protein Planetary Health Diet
Planetary Health Diet Meal with 62 g of protein primarily from plant origin
• Low Protein Planetary Health Diet
Planetary Health Diet Meal with 36 g of protein primarily from plant origin
• High Protein Western Diet
Western Diet Meal with 62 g of protein primarily from animal origin
• Low Protein Western Diet
Western Diet Meal with 36 g of protein primarily from animal origin

Locations

Country	Name	City	State
Germany	University of Bonn, Institute of Nutritional and Food Sciences, Nutrition Physiology	Bonn	North-Rhine Westphalia

Sponsors (3)

Lead Sponsor	Collaborator
University of Bonn	Federal Ministry of Food and Agriculture (BMEL), Federal Office for Agriculture and Food (BLE)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parameters of lipid metabolism in blood	Triglycerides (mg/dL)	Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Secondary	Parameters of lipid metabolism in blood	Total cholesterol (mg/dL)	Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Secondary	Parameters of lipid metabolism in blood	LDL cholesterol (mg/dL)	Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Secondary	Parameters of lipid metabolism in blood	HDL cholesterol (mg/dL)	Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Secondary	Parameters of lipid metabolism in blood	Free fatty acids (mmol/L)	Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Parameters of glucose metabolism in blood	GLP-1 (pg/mL)	Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
Secondary	Parameters of glucose metabolism in blood	Glucagon (pg/mL)	Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
Secondary	Blood amino acid profile	Amino acid profile in blood (nmol/mL)	Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
Secondary	Blood urea	Urea in blood (mg/dL)	Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Secondary	Uric acid in blood	Uric acid in blood (mg/dL)	Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Secondary	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)
Secondary	Parameters of endothelial function in blood	e.g. ADMA (µmo/L)	Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
Secondary	Parameters of inflammation in blood	e.g. IL-6 (pg/mL)	Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
Secondary	Endothelial function	e.g. pulse wave velocity (m/s)	Postprandial period of 6 hours (T=0, 2, 4, 6 hours)
Secondary	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)
Secondary	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)
Secondary	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)