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NCT Number: NCT06700954

Effects of a Legume-rich Diet in the Context of the Planetary Health Diet Compared to a Western-oriented Dietary Pattern in Participants with Increased Cardiometabolic Risk

The aim of the study is to systematically investigate the effects of a diet enriched with legumes in a dietary pattern approach (Planetary Health Diet) compared to a control diet low in legumes in older people with a risk phenotype for cardiovascular and neurodegenerative diseases. For this purpose, a controlled, six-week nutritional intervention study will be carried out in a parallel design. A total of 100 subjects (aged 50 - 75 years) will be randomly assigned to one of two intervention groups: i) a legume-rich diet based on the Planetary Health Diet, with a focus on plant protein, ii) a diet based on the Western dietary pattern including animal protein sources (= control diet). The target variables include parameters of lipid, glucose and insulin metabolism as well as biomarkers of inflammation and endothelial activation, proteomics and neurodegeneration markers. Furthermore, pulse wave velocity is measured to assess vascular function and neuropsychological target variables (e.g. hunger, satiety) are recorded using questionnaires.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Nutritional and Food Sciences, Nutrition Physiology

Bonn, North Rhine-Westphalia, 53113, Germany

Location contact

Sarah Egert, Prof PhD

CONTACT

[email protected]

+ 49 (0) 228/73 59 53

About this study

The aim of the study is to systematically investigate the effects of a diet enriched with legumes in the dietary pattern approach (Planetary Health Diet) compared to a control diet low in legumes in older people with a risk phenotype for cardiovascular and neurodegenerative diseases. For this purpose, a controlled, six-week nutritional intervention study will be carried out in a parallel design. A total of 100 subjects (aged 50 - 75 years) will be randomly assigned to one of two intervention groups: i) a legume-rich diet based on the Planetary Health Diet, with a focus on plant protein, ii) a diet based on the Western dietary pattern including animal protein sources (= control diet). The target variables include parameters of lipid, glucose and insulin metabolism as well as biomarkers of inflammation and endothelial activation, proteomics and neurodegeneration markers. Furthermore, pulse wave velocity is measured to assess vascular function and neuropsychological target variables (e.g. hunger, satiety) are recorded using questionnaires. The subjects come to the study center for examination before the start of the intervention (visit 1), after three weeks (mid-intervention, visit 2) and after six weeks (end of intervention, visit 3).

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 LDL cholesterol in serum ≥160 mg/dL
  • Fasting HDL-Cholesterol in serum: women < 50 mg/dl, men < 40 mg/dL
  • Fasting glucose in plasma: ≥ 100 mg/dL
  • CRP in serum 0,2-3 mg/dL

Exclusion criteria

  • food intolerances and allergies (especially 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

legume-rich Planetary Health Diet

Other

legume-rich diet based on the Planetary Health Diet, with a focus on vegetable protein

control diet based on Western Diet low in legumes

Other

diet based on the Western dietary pattern including animal protein sources (= control diet)

Primary outcomes

  1. Pameters of glucose metabolism in blood

    Time frame: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention

    Glucose (mg/dL)

Secondary outcomes

  1. Parameters of glucose metabolism in blood

    Time frame: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention

    Insulin (nmol/L)

  2. Parameters of glucose metabolism in blood

    Time frame: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention

    GLP-1 (pg/mL)

  3. Parameters of glucose metabolism in blood

    Time frame: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention

    Glucagon (pg/mL)

  4. Parameters of glucose metabolism in blood

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    HbA1c (%)

  5. Parameters of glucose metabolism in blood

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    Fructosamine (µmol/l)

  6. Parameters of lipid metabolism in blood

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    Triglycerides (mg/dL)

  7. Parameters of lipid metabolism in blood

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    Total cholesterol (mg/dL)

  8. Parameters of lipid metabolism in blood

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    LDL cholesterol (mg/dL)

  9. Parameters of lipid metabolism in blood

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    HDL cholesterol (mg/dL)

  10. Parameters of lipid metabolism in blood

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    Free fatty acids (mmol/L)

  11. Parameters of lipid metabolism in blood

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    Lipoprotein(a) (mg/dL/nmol/L)

  12. Parameters of lipid metabolism in blood

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    Apo A1 (g/L)

  13. Parameters of lipid metabolism in blood

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    Apo B (g/L)

  14. Parameters of lipid metabolism in blood

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    Fatty acid composition of serum phospholipids

  15. Blood urea

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    Urea in blood (mg/dL)

  16. Uric acid in blood

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    Uric acid in blood (mg/dL)

  17. Parameters of endothelial function in blood

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    ADMA (µmo/L)

  18. Parameters of inflammation in blood

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    IL-6 (pg/mL)

  19. Parameters of Hunger and Satiety in blood

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    Ghrelin (pg/mL)

  20. Endothelial function

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    pulse wave velocity (m/s) with the vicorder device

  21. Liver enzymes

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    GGT (U/L)

  22. Liver enzymes

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    ALT (U/L)

  23. Liver enzymes

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    AST (U/L)

  24. Small blood count

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

  25. Ferritin

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    Ferritin (µg/L)

  26. Adiponectin

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    Adiponectin (µg/ml)

  27. Parameters oft the antioxidant system

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    vitamin C

  28. Parameters oft the antioxidant system

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    vitamin E

  29. Parameters oft the antioxidant system

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    ß-carotine

  30. Parameters oft the antioxidant system

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    B vitamins

  31. trace elements

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    iron

  32. trace elements

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    cupper

  33. trace elements

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    zinc

  34. trace elements

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    selen

  35. Proteomics

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

  36. Neurodegenerative markers

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    GFAP

  37. Neurodegenerative markers

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    Aβ42

  38. Neurodegenerative markers

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    Aβ40

  39. Neurodegenerative markers

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    NF-L

  40. Blood pressure

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    Blood pressure (mmHg)

  41. REE

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    REE (kcal/24h)

  42. Anthropometic measurements

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    weight (kg)

  43. Anthropometic measurements

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    fat mass (%)

  44. Anthropometic measurements

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    waist circumference (cm)

  45. Neuropsychological parameters

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

    Assessment of memory via a validated neuropsychological questionaire (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)

  46. Fecal fatty acid profile

    Time frame: Fasting (t=0) in week 1 and week 6 of intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Egert, Prof PhD

CONTACT

[email protected]

+ 49 (0) 228 / 73 59 53

Sponsors and collaborators

Lead sponsor

University of Bonn

Other

Collaborators

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

Registry information

Official study title

Effects of a Legume-rich Diet in the Context of the Planetary Health Diet Compared to a Western-oriented Dietary Pattern in Women and Men At Increased Risk of Cardiovascular and Neurodegenerative Diseases

Acronym: LeguPlan_2

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2024
Registry last updated
Nov 22, 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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