Acute Effects of Legume-enriched Meals Compared to Western Diet Meals on Postprandial Metabolism in Participants with Increased Cardiometabolic Risk (LeguPlan_1)

October 29, 2024 updated by: Prof. Dr. Sarah Egert, University of Bonn

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • North-Rhine Westphalia
      • Bonn, North-Rhine Westphalia, Germany, 53115
        • University of Bonn, Institute of Nutritional and Food Sciences, Nutrition Physiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High Protein Planetary Health Diet
High Protein Planetary Health Diet Meal: This meal contains 62 g of protein primarily from plant origin (particularly legumes)
Other: High Protein Planetary Health Diet
Planetary Health Diet Meal with 62 g of protein primarily from plant origin
Experimental: Low Protein Planetary Health Diet
Low Protein Planetary Health Diet Meal: This meal contains 36 g of protein from primarily plant origin (particularly legumes)
Other: Low Protein Planetary Health Diet
Planetary Health Diet Meal with 36 g of protein primarily from plant origin
Experimental: High Protein Western Diet
High Protein Western Diet Meal: This meal contains 62 g of protein primarily form animal origin
Other: High Protein Western Diet
Western Diet Meal with 62 g of protein primarily from animal origin
Experimental: Low Protein Western Diet
Low Protein Western Diet Meal: This meal contains 36 g of protein primarily from animal origin
Other: Low Protein Western Diet
Western Diet Meal with 36 g of protein primarily from animal origin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Parameters of lipid metabolism in blood
Time Frame: Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)
Triglycerides (mg/dL)
Postprandial period of 6 hours (T=0, 1, 2, 3, 4, 6 hours)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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)
LDL cholesterol (mg/dL)
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)
HDL cholesterol (mg/dL)
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)
Free fatty acids (mmol/L)
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)
Glucose (mg/dL)
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)
Insulin (nmol/L)
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)
cPeptide (pg/mL)
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)
GLP-1 (pg/mL)
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)
Glucagon (pg/mL)
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)
Amino acid profile in blood (nmol/mL)
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)
Urea in blood (mg/dL)
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)
Uric acid in blood (mg/dL)
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)
e.g. Ghrelin (pg/mL)
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)
e.g. ADMA (µmo/L)
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)
e.g. IL-6 (pg/mL)
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)
e.g. pulse wave velocity (m/s)
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)
Assessment of hunger and satiety via a visual analogue scale (e.g. 0 = not hungry at all to 10 = very hungry)
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)
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)
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)
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)
Postprandial period of 6 hours (T=0.5, 3, 6 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Bonn

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Federal Ministry of Food and Agriculture (BMEL)
Federal Office for Agriculture and Food (BLE)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 11, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 11, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BMEL: 2822EPS008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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