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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Bonn
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Parameters of lipid metabolism in blood
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
- •malabsorption syndromes
- •thyroid diseases
- •impaired renal function
- •chronic liver disease
- •heart failure
- •myocardial infarction
- •insulin-dependent diabetes mellitus
- •chronic inflammatory diseases
- •immunosuppression
- •intake of supplements (e.g., fish oil)
- •Participation in another study
- •other exclusion criteria at the discretion of the physician/ investigator
Arms & Interventions
High Protein Planetary Health Diet
High Protein Planetary Health Diet Meal: This meal contains 62 g of protein primarily from plant origin (particularly legumes)
Intervention: High Protein Planetary Health Diet (Other)
Low Protein Planetary Health Diet
Low Protein Planetary Health Diet Meal: This meal contains 36 g of protein from primarily plant origin (particularly legumes)
Intervention: Low Protein Planetary Health Diet (Other)
High Protein Western Diet
High Protein Western Diet Meal: This meal contains 62 g of protein primarily form animal origin
Intervention: High Protein Western Diet (Other)
Low Protein Western Diet
Low Protein Western Diet Meal: This meal contains 36 g of protein primarily from animal origin
Intervention: Low Protein Western Diet (Other)
Outcomes
Primary Outcomes
Parameters of lipid metabolism in blood
Time Frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Triglycerides (mg/dL)
Secondary Outcomes
- Parameters of lipid metabolism in blood(Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours))
- Parameters of glucose metabolism in blood(Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours))
- Parameters of endothelial function in blood(Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours))
- Blood urea(Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours))
- Endothelial function(Postprandial period of 6 hours (T=0, 2, 4, 6 hours))
- Parameters of hunger and satiety in blood(Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours))
- Blood amino acid profile(Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours))
- Uric acid in blood(Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours))
- Parameters of inflammation in blood(Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours))
- Neuropsychological parameters(Postprandial period of 6 hours (T=0.5, 3, 6 hours))
- Parameters of glucose metabolism in blood(Postprandial period of 6 hours (T=0, 0.5, 1, 1.5, 2, 3, 4, 6 hours))
- Neuropsychological parameters(Postprandial period of 6 hours (T=0, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours))
- Neuropsychological parameters(Postprandial period of 4.5 hours (T= 0, 1.5, 3, 4.5 hours))
Investigators
Prof. Dr. Sarah Egert
Sarah Egert, Prof PhD
University of Bonn