Cardiovascular DiseasesLeguPlan_2NCT06700954
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
A study testing legume-rich Planetary Health Diet in people with Cardiovascular Diseases, run by University of Bonn at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- legume-rich Planetary Health Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 6 Jan 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 11Show fewer
- 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
Who cannot join
- food intolerances and allergies (especially legumes)
- Smoking
- malabsorption syndromes
- thyroid diseases
- impaired renal function
- chronic liver disease
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Institute of Nutritional and Food Sciences, Nutrition Physiology
Bonn, North Rhine-Westphalia, 53113
Sarah Egert, Prof PhD, + 49 (0) 228/73 59 53, s.egert@uni-bonn.de
About this study
Official 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
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.
Read the detailed description
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).
- Conditions
- Cardiovascular Diseases
- Being tested
- legume-rich Planetary Health Diet, control diet based on Western Diet low in legumes
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
legume-rich Planetary Health DietOther
legume-rich diet based on the Planetary Health Diet, with a focus on vegetable protein
control diet based on Western Diet low in legumesOther
diet based on the Western dietary pattern including animal protein sources (= control diet)
| Study group | Role | What they receive |
|---|---|---|
| legume-rich Planetary Health Diet | Experimental | legume-rich diet based on the Planetary Health Diet, with a focus on vegetable protein Receives: Other: legume-rich Planetary Health Diet |
| control diet based on Western Diet low in legumes | Experimental | diet based on the Western dietary pattern including animal protein sources (= control diet) Receives: Other: control diet based on Western Diet low in legumes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pameters of glucose metabolism in blood
Glucose (mg/dL)
Measured: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention
Secondary outcomes (46)
Parameters of glucose metabolism in blood
Insulin (nmol/L)
Measured: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention
Parameters of glucose metabolism in blood
GLP-1 (pg/mL)
Measured: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention
Parameters of glucose metabolism in blood
Glucagon (pg/mL)
Measured: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention
Parameters of glucose metabolism in blood
HbA1c (%)
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of glucose metabolism in blood
Fructosamine (µmol/l)
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
Triglycerides (mg/dL)
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
Total cholesterol (mg/dL)
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
LDL cholesterol (mg/dL)
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
HDL cholesterol (mg/dL)
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
Free fatty acids (mmol/L)
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
Lipoprotein(a) (mg/dL/nmol/L)
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
Apo A1 (g/L)
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
Apo B (g/L)
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
Fatty acid composition of serum phospholipids
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Blood urea
Urea in blood (mg/dL)
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Uric acid in blood
Uric acid in blood (mg/dL)
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of endothelial function in blood
ADMA (µmo/L)
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of inflammation in blood
IL-6 (pg/mL)
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of Hunger and Satiety in blood
Ghrelin (pg/mL)
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Endothelial function
pulse wave velocity (m/s) with the vicorder device
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Liver enzymes
GGT (U/L)
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Liver enzymes
ALT (U/L)
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Liver enzymes
AST (U/L)
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Small blood count
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Ferritin
Ferritin (µg/L)
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Adiponectin
Adiponectin (µg/ml)
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Parameters oft the antioxidant system
vitamin C
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Parameters oft the antioxidant system
vitamin E
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Parameters oft the antioxidant system
ß-carotine
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Parameters oft the antioxidant system
B vitamins
Measured: Fasting (t=0) in week 1 and week 6 of intervention
trace elements
iron
Measured: Fasting (t=0) in week 1 and week 6 of intervention
trace elements
cupper
Measured: Fasting (t=0) in week 1 and week 6 of intervention
trace elements
zinc
Measured: Fasting (t=0) in week 1 and week 6 of intervention
trace elements
selen
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Proteomics
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Neurodegenerative markers
GFAP
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Neurodegenerative markers
Aβ42
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Neurodegenerative markers
Aβ40
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Neurodegenerative markers
NF-L
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Blood pressure
Blood pressure (mmHg)
Measured: Fasting (t=0) in week 1 and week 6 of intervention
REE
REE (kcal/24h)
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Anthropometic measurements
weight (kg)
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Anthropometic measurements
fat mass (%)
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Anthropometic measurements
waist circumference (cm)
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Neuropsychological parameters
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)
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Fecal fatty acid profile
Measured: Fasting (t=0) in week 1 and week 6 of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start6 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Ministry of Food and Agriculture (BMEL), Federal Office of Agriculture and Food (BLE)
- Responsible party
- Principal investigator, Prof. Dr. Sarah Egert, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700954
- Sponsor's protocol ID
- BMEL: 2822EPS008 2
- Acronym
- LeguPlan_2
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06700954
- Acronym / sponsor ID
- LeguPlan_2 / BMEL: 2822EPS008 2
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of BonnUniversity, hospital or other
- Collaborators
- Federal Ministry of Food and Agriculture (BMEL), Federal Office of Agriculture and Food (BLE)
- Study start
- 6 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| legume-rich Planetary Health Diet | Experimental | Other: legume-rich Planetary Health Dietlegume-rich diet based on the Planetary Health Diet, with a focus on vegetable protein |
| control diet based on Western Diet low in legumes | Experimental | Other: control diet based on Western Diet low in legumesdiet based on the Western dietary pattern including animal protein sources (= control diet) |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (16 listed)
- food intolerances and allergies (especially legumes)
- Smoking
- malabsorption syndromes
- thyroid diseases
- impaired renal function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| legume-rich Planetary Health Dietlegume-rich diet based on the Planetary Health Diet, with a focus on vegetable protein | Other | legume-rich Planetary Health Diet |
| control diet based on Western Diet low in legumesdiet based on the Western dietary pattern including animal protein sources (= control diet) | Other | control diet based on Western Diet low in legumes |
Primary outcome
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)
46 secondary outcomes
Parameters of glucose metabolism in blood
Time frame: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention
Parameters of glucose metabolism in blood
Time frame: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention
Parameters of glucose metabolism in blood
Time frame: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention
Parameters of glucose metabolism in blood
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of glucose metabolism in blood
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of lipid metabolism in blood
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Blood urea
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Uric acid in blood
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of endothelial function in blood
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of inflammation in blood
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters of Hunger and Satiety in blood
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Endothelial function
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Liver enzymes
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Liver enzymes
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Liver enzymes
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Small blood count
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Ferritin
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Adiponectin
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters oft the antioxidant system
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters oft the antioxidant system
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters oft the antioxidant system
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Parameters oft the antioxidant system
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
trace elements
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
trace elements
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
trace elements
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
trace elements
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Proteomics
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Neurodegenerative markers
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Neurodegenerative markers
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Neurodegenerative markers
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Neurodegenerative markers
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Blood pressure
Time frame: Fasting (t=0) in week 1 and week 6 of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing legume-rich Planetary Health Diet in people with Cardiovascular Diseases, run by University of Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Egert, Prof PhD (+ 49 (0) 228 / 73 59 53, s.egert@uni-bonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pameters of glucose metabolism in blood (time frame: postprandial period of 2 hours (t = 0,2) in week 1 and week 6 of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.