Clinical trial NCT06270901: Acute Effects of Legume-enriched Meals Compared to Western Diet Meals on Postprandial Metabolism in Participants with Increased Cardiometabolic Risk
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Metabolic Syndrome
Keywords: postprandial metabolic events
Lead sponsor: University of Bonn
Sponsor class: OTHER
Collaborators: name: Federal Ministry of Food and Agriculture (BMEL)
name: Federal Office for Agriculture and Food (BLE)
First posted: 2024-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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
* other exclusion criteria at the discretion of the physician/ investigator

Primary outcomes:
measure: Parameters of lipid metabolism in blood
timeFrame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Secondary outcomes:
measure: Parameters of lipid metabolism in blood
timeFrame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
measure: Parameters of lipid metabolism in blood
timeFrame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
measure: Parameters of lipid metabolism in blood
timeFrame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
measure: Parameters of lipid metabolism in blood
timeFrame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
measure: Parameters of glucose metabolism in blood
timeFrame: Postprandial period of 6 hours (T=0, 0.5, 1, 1.5, 2, 3, 4, 6 hours)
measure: Parameters of glucose metabolism in blood
timeFrame: Postprandial period of 6 hours (T=0, 0.5, 1, 1.5, 2, 3, 4, 6 hours)
measure: Parameters of glucose metabolism in blood
timeFrame: Postprandial period of 6 hours (T=0, 0.5, 1, 1.5, 2, 3, 4, 6 hours)
measure: Parameters of glucose metabolism in blood
timeFrame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
measure: Parameters of glucose metabolism in blood
timeFrame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
measure: Blood amino acid profile
timeFrame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
measure: Blood urea
timeFrame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
measure: Uric acid in blood
timeFrame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
measure: Parameters of hunger and satiety in blood
timeFrame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
measure: Parameters of endothelial function in blood
timeFrame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
measure: Parameters of inflammation in blood
timeFrame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
measure: Endothelial function
timeFrame: Postprandial period of 6 hours (T=0, 2, 4, 6 hours)
measure: Neuropsychological parameters
timeFrame: Postprandial period of 6 hours (T=0, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours)
measure: Neuropsychological parameters
timeFrame: Postprandial period of 4.5 hours (T= 0, 1.5, 3, 4.5 hours)
measure: Neuropsychological parameters
timeFrame: Postprandial period of 6 hours (T=0.5, 3, 6 hours)
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University of Bonn, Institute of Nutritional and Food Sciences, Nutrition Physiology
state: North-Rhine Westphalia
Study officials:
References: