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Completed

NCT Number: NCT06270901

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

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bonn, North Rhine-Westphalia, 53115, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Protein Planetary Health Diet

Other

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

Low Protein Planetary Health Diet

Other

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

High Protein Western Diet

Other

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

Low Protein Western Diet

Other

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

Primary outcomes

  1. 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

  1. Parameters of lipid metabolism in blood

    Time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)

    Total cholesterol (mg/dL)

  2. Parameters of lipid metabolism in blood

    Time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)

    LDL cholesterol (mg/dL)

  3. Parameters of lipid metabolism in blood

    Time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)

    HDL cholesterol (mg/dL)

  4. Parameters of lipid metabolism in blood

    Time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)

    Free fatty acids (mmol/L)

  5. Parameters of glucose metabolism in blood

    Time frame: Postprandial period of 6 hours (T=0, 0.5, 1, 1.5, 2, 3, 4, 6 hours)

    Glucose (mg/dL)

  6. Parameters of glucose metabolism in blood

    Time frame: Postprandial period of 6 hours (T=0, 0.5, 1, 1.5, 2, 3, 4, 6 hours)

    Insulin (nmol/L)

  7. Parameters of glucose metabolism in blood

    Time frame: Postprandial period of 6 hours (T=0, 0.5, 1, 1.5, 2, 3, 4, 6 hours)

    cPeptide (pg/mL)

  8. Parameters of glucose metabolism in blood

    Time frame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)

    GLP-1 (pg/mL)

  9. Parameters of glucose metabolism in blood

    Time frame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)

    Glucagon (pg/mL)

  10. Blood amino acid profile

    Time frame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)

    Amino acid profile in blood (nmol/mL)

  11. Blood urea

    Time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)

    Urea in blood (mg/dL)

  12. Uric acid in blood

    Time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)

    Uric acid in blood (mg/dL)

  13. Parameters of hunger and satiety in blood

    Time frame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)

    e.g. Ghrelin (pg/mL)

  14. Parameters of endothelial function in blood

    Time frame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)

    e.g. ADMA (µmo/L)

  15. Parameters of inflammation in blood

    Time frame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)

    e.g. IL-6 (pg/mL)

  16. Endothelial function

    Time frame: Postprandial period of 6 hours (T=0, 2, 4, 6 hours)

    e.g. pulse wave velocity (m/s)

  17. Neuropsychological parameters

    Time frame: Postprandial 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)

  18. Neuropsychological parameters

    Time frame: Postprandial period of 4.5 hours (T= 0, 1.5, 3, 4.5 hours)

    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)

  19. Neuropsychological parameters

    Time frame: Postprandial period of 6 hours (T=0.5, 3, 6 hours)

    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)

Sponsors and collaborators

Lead sponsor

University of Bonn

Other

Collaborators

  • Federal Ministry of Food and Agriculture (BMEL)
  • Federal Office for Agriculture and Food (BLE)

Registry information

Official study 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

Acronym: LeguPlan_1

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2024
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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