Cardiovascular DiseasesLeguPlan_1NCT06270901
Acute Effects of Legume-enriched Meals Compared to Western Diet Meals on Postprandial Metabolism in Participants with Increased Cardiometabolic Risk
A study testing High Protein Planetary Health Diet, Low Protein Planetary Health Diet and High Protein Western Diet in people with Cardiovascular Diseases and Metabolic Syndrome, run by University of Bonn at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Cardiovascular Diseases, Metabolic Syndrome
- What is being tested?
- High Protein Planetary Health Diet, Low Protein Planetary Health Diet and High Protein Western Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 2 May 2024to 11 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
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- 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
Who cannot join
- food intolerances and allergies (especially to 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.
Germany1 site
University of Bonn, Institute of Nutritional and Food Sciences, Nutrition Physiology
Bonn, North Rhine-Westphalia, 53115
About this study
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
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Metabolic Syndrome
- Being tested
- High Protein Planetary Health Diet, Low Protein Planetary Health Diet, High Protein Western Diet, Low Protein Western Diet
- Keywords
- postprandial metabolic events
- Medical subject headings
- Cardiovascular Diseases, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Protein Planetary Health DietOther
Planetary Health Diet Meal with 62 g of protein primarily from plant origin
Low Protein Planetary Health DietOther
Planetary Health Diet Meal with 36 g of protein primarily from plant origin
High Protein Western DietOther
Western Diet Meal with 62 g of protein primarily from animal origin
Low Protein Western DietOther
Western Diet Meal with 36 g of protein primarily from animal origin
| Study group | Role | What they receive |
|---|---|---|
| High Protein Planetary Health Diet | Experimental | High Protein Planetary Health Diet Meal: This meal contains 62 g of protein primarily from plant origin (particularly legumes) Receives: Other: High Protein Planetary Health Diet |
| Low Protein Planetary Health Diet | Experimental | Low Protein Planetary Health Diet Meal: This meal contains 36 g of protein from primarily plant origin (particularly legumes) Receives: Other: Low Protein Planetary Health Diet |
| High Protein Western Diet | Experimental | High Protein Western Diet Meal: This meal contains 62 g of protein primarily form animal origin Receives: Other: High Protein Western Diet |
| Low Protein Western Diet | Experimental | Low Protein Western Diet Meal: This meal contains 36 g of protein primarily from animal origin Receives: Other: Low Protein Western Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parameters of lipid metabolism in blood
Triglycerides (mg/dL)
Measured: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Secondary outcomes (19)
Parameters of lipid metabolism in blood
Total cholesterol (mg/dL)
Measured: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Parameters of lipid metabolism in blood
LDL cholesterol (mg/dL)
Measured: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Parameters of lipid metabolism in blood
HDL cholesterol (mg/dL)
Measured: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Parameters of lipid metabolism in blood
Free fatty acids (mmol/L)
Measured: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Parameters of glucose metabolism in blood
Glucose (mg/dL)
Measured: Postprandial period of 6 hours (T=0, 0.5, 1, 1.5, 2, 3, 4, 6 hours)
Parameters of glucose metabolism in blood
Insulin (nmol/L)
Measured: Postprandial period of 6 hours (T=0, 0.5, 1, 1.5, 2, 3, 4, 6 hours)
Parameters of glucose metabolism in blood
cPeptide (pg/mL)
Measured: Postprandial period of 6 hours (T=0, 0.5, 1, 1.5, 2, 3, 4, 6 hours)
Parameters of glucose metabolism in blood
GLP-1 (pg/mL)
Measured: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
Parameters of glucose metabolism in blood
Glucagon (pg/mL)
Measured: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
Blood amino acid profile
Amino acid profile in blood (nmol/mL)
Measured: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
Blood urea
Urea in blood (mg/dL)
Measured: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Uric acid in blood
Uric acid in blood (mg/dL)
Measured: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Parameters of hunger and satiety in blood
e.g. Ghrelin (pg/mL)
Measured: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
Parameters of endothelial function in blood
e.g. ADMA (µmo/L)
Measured: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
Parameters of inflammation in blood
e.g. IL-6 (pg/mL)
Measured: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
Endothelial function
e.g. pulse wave velocity (m/s)
Measured: Postprandial period of 6 hours (T=0, 2, 4, 6 hours)
Neuropsychological parameters
Assessment of hunger and satiety via a visual analogue scale (e.g. 0 = not hungry at all to 10 = very hungry)
Measured: Postprandial period of 6 hours (T=0, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours)
Neuropsychological parameters
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)
Measured: Postprandial period of 4.5 hours (T= 0, 1.5, 3, 4.5 hours)
Neuropsychological parameters
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)
Measured: Postprandial period of 6 hours (T=0.5, 3, 6 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start2 May 2024
- Primary completion11 Sep 2024
- Study completion11 Sep 2024
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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Ministry of Food and Agriculture (BMEL), Federal Office for Agriculture and Food (BLE)
- Responsible party
- Principal investigator, Prof. Dr. Sarah Egert, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270901
- Sponsor's protocol ID
- BMEL: 2822EPS008
- Acronym
- LeguPlan_1
- Status last verified
- May 2024
- First submitted
- 2 Feb 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06270901
- Acronym / sponsor ID
- LeguPlan_1 / BMEL: 2822EPS008
- Conditions
- Cardiovascular Diseases, Metabolic Syndrome
- Keywords
- postprandial metabolic events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of BonnUniversity, hospital or other
- Collaborators
- Federal Ministry of Food and Agriculture (BMEL), Federal Office for Agriculture and Food (BLE)
- Study start
- 2 May 2024 (actual)
- Primary completion
- 11 Sep 2024 (actual)
- Study completion
- 11 Sep 2024 (actual)
- First posted
- 21 Feb 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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High Protein Planetary Health Diet | Experimental | Other: High Protein Planetary Health DietHigh Protein Planetary Health Diet Meal: This meal contains 62 g of protein primarily from plant origin (particularly legumes) |
| Low Protein Planetary Health Diet | Experimental | Other: Low Protein Planetary Health DietLow Protein Planetary Health Diet Meal: This meal contains 36 g of protein from primarily plant origin (particularly legumes) |
| High Protein Western Diet | Experimental | Other: High Protein Western DietHigh Protein Western Diet Meal: This meal contains 62 g of protein primarily form animal origin |
| Low Protein Western Diet | Experimental | Other: Low Protein Western DietLow Protein Western Diet Meal: This meal contains 36 g of protein primarily from animal origin |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 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 to 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 |
|---|---|---|
| High Protein Planetary Health DietPlanetary Health Diet Meal with 62 g of protein primarily from plant origin | Other | High Protein Planetary Health Diet |
| Low Protein Planetary Health DietPlanetary Health Diet Meal with 36 g of protein primarily from plant origin | Other | Low Protein Planetary Health Diet |
| High Protein Western DietWestern Diet Meal with 62 g of protein primarily from animal origin | Other | High Protein Western Diet |
| Low Protein Western DietWestern Diet Meal with 36 g of protein primarily from animal origin | Other | Low Protein Western Diet |
Primary outcome
Parameters of lipid metabolism in blood
Time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Triglycerides (mg/dL)
19 secondary outcomes
Parameters of lipid metabolism in blood
Time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Parameters of lipid metabolism in blood
Time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Parameters of lipid metabolism in blood
Time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Parameters of lipid metabolism in blood
Time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
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)
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)
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)
Parameters of glucose metabolism in blood
Time frame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
Parameters of glucose metabolism in blood
Time frame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
Blood amino acid profile
Time frame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
Blood urea
Time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Uric acid in blood
Time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Parameters of hunger and satiety in blood
Time frame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
Parameters of endothelial function in blood
Time frame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
Parameters of inflammation in blood
Time frame: Postprandial period of 6 hours (T= 0, 1, 2, 3, 4, 6 hours)
Endothelial function
Time frame: Postprandial period of 6 hours (T=0, 2, 4, 6 hours)
Neuropsychological parameters
Time frame: Postprandial period of 6 hours (T=0, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours)
Neuropsychological parameters
Time frame: Postprandial period of 4.5 hours (T= 0, 1.5, 3, 4.5 hours)
Neuropsychological parameters
Time frame: Postprandial period of 6 hours (T=0.5, 3, 6 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Protein Planetary Health Diet, Low Protein Planetary Health Diet and High Protein Western Diet in people with Cardiovascular Diseases and Metabolic Syndrome, 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 10 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: finished, as of the sponsor's last update on 1 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parameters of lipid metabolism in blood (time frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)). 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 1 Nov 2024.