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

NCT ID: NCT06270901

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-02
• Study Completion Date: 2024-09-11

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.

Conditions

Cardiovascular Diseases; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

High Protein Planetary Health Diet

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

Group Type: EXPERIMENTAL

High Protein Planetary Health Diet

Intervention Type: OTHER

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

Low Protein Planetary Health Diet

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

Group Type: EXPERIMENTAL

Low Protein Planetary Health Diet

Intervention Type: OTHER

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

High Protein Western Diet

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

Group Type: EXPERIMENTAL

High Protein Western Diet

Intervention Type: OTHER

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

Low Protein Western Diet

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

Group Type: EXPERIMENTAL

Low Protein Western Diet

Intervention Type: OTHER

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

Interventions

High Protein Planetary Health Diet

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

Intervention Type: OTHER

Low Protein Planetary Health Diet

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

Intervention Type: OTHER

High Protein Western Diet

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

Intervention Type: OTHER

Low Protein Western Diet

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal Ministry of Food and Agriculture (BMEL)

UNKNOWN

Sponsor Role: collaborator

Federal Office for Agriculture and Food (BLE)

UNKNOWN

Sponsor Role: collaborator

University of Bonn

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Sarah Egert

Sarah Egert, Prof PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Bonn, Institute of Nutritional and Food Sciences, Nutrition Physiology

Bonn, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

BMEL: 2822EPS008

Identifier Type: -

Identifier Source: org_study_id