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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06270901
Acronym
LeguPlan_1
Enrollment
30
Registered
2024-02-21
Start date
2024-05-02
Completion date
2024-09-11
Last updated
2024-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Metabolic Syndrome

Keywords

postprandial metabolic events

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.

Interventions

OTHERHigh Protein Planetary Health Diet

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

OTHERLow Protein Planetary Health Diet

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

OTHERHigh Protein Western Diet

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

OTHERLow Protein Western Diet

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

Sponsors

Federal Ministry of Food and Agriculture (BMEL)
CollaboratorUNKNOWN
Federal Office for Agriculture and Food (BLE)
CollaboratorUNKNOWN
University of Bonn
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
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) * 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

Design outcomes

Primary

MeasureTime frameDescription
Parameters of lipid metabolism in bloodPostprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)Triglycerides (mg/dL)

Secondary

MeasureTime frameDescription
Parameters of lipid metabolism in bloodPostprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)Total cholesterol (mg/dL)
Blood amino acid profilePostprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)Amino acid profile in blood (nmol/mL)
Blood ureaPostprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)Urea in blood (mg/dL)
Uric acid in bloodPostprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)Uric acid in blood (mg/dL)
Parameters of glucose metabolism in bloodPostprandial period of 6 hours (T=0, 0.5, 1, 1.5, 2, 3, 4, 6 hours)Glucose (mg/dL)
Parameters of endothelial function in bloodPostprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)e.g. ADMA (µmo/L)
Parameters of inflammation in bloodPostprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)e.g. IL-6 (pg/mL)
Endothelial functionPostprandial period of 6 hours (T=0, 2, 4, 6 hours)e.g. pulse wave velocity (m/s)
Neuropsychological parametersPostprandial period of 6 hours (T=0, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours)Assessment of hunger and satiety via a visual analogue scale (e.g. 0 = not hungry at all to 10 = very hungry)
Parameters of hunger and satiety in bloodPostprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)e.g. Ghrelin (pg/mL)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026