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 (LeguPlan_2)

November 19, 2024 updated by: Prof. Dr. Sarah Egert, University of Bonn

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

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 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 (Estimated)

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.
100

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
    • North-Rhine Westphalia
      • Bonn, North-Rhine Westphalia, Germany, 53113
        • Institute of Nutritional and Food Sciences, Nutrition Physiology
        • Contact:

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 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

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: Parallel 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: legume-rich Planetary Health Diet
legume-rich diet based on the Planetary Health Diet, with a focus on vegetable protein
Other: legume-rich Planetary Health Diet
legume-rich diet based on the Planetary Health Diet, with a focus on vegetable protein
Experimental: control diet based on Western Diet low in legumes
diet based on the Western dietary pattern including animal protein sources (= control diet)
Other: control diet based on Western Diet low in legumes
diet based on the Western dietary pattern including animal protein sources (= control diet)

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

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 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)
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
GLP-1 (pg/mL)
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
Glucagon (pg/mL)
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
HbA1c (%)
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
Fructosamine (µmol/l)
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
Triglycerides (mg/dL)
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
Total cholesterol (mg/dL)
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
LDL cholesterol (mg/dL)
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
HDL cholesterol (mg/dL)
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
Free fatty acids (mmol/L)
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
Lipoprotein(a) (mg/dL/nmol/L)
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
Apo A1 (g/L)
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
Apo B (g/L)
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
Fatty acid composition of serum phospholipids
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
Urea in blood (mg/dL)
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
Uric acid in blood (mg/dL)
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
ADMA (µmo/L)
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
IL-6 (pg/mL)
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
Ghrelin (pg/mL)
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
pulse wave velocity (m/s) with the vicorder device
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
GGT (U/L)
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
ALT (U/L)
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
AST (U/L)
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
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
Ferritin (µg/L)
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
Adiponectin (µg/ml)
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
vitamin C
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
vitamin E
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
ß-carotine
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
B vitamins
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
iron
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
cupper
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
zinc
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
selen
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
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
GFAP
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
Aβ42
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
Aβ40
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
NF-L
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
Blood pressure (mmHg)
Fasting (t=0) in week 1 and week 6 of intervention
REE
Time Frame: Fasting (t=0) in week 1 and week 6 of intervention
REE (kcal/24h)
Fasting (t=0) in week 1 and week 6 of intervention
Anthropometic measurements
Time Frame: Fasting (t=0) in week 1 and week 6 of intervention
weight (kg)
Fasting (t=0) in week 1 and week 6 of intervention
Anthropometic measurements
Time Frame: Fasting (t=0) in week 1 and week 6 of intervention
fat mass (%)
Fasting (t=0) in week 1 and week 6 of intervention
Anthropometic measurements
Time Frame: Fasting (t=0) in week 1 and week 6 of intervention
waist circumference (cm)
Fasting (t=0) in week 1 and week 6 of intervention
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)
Fasting (t=0) in week 1 and week 6 of intervention
Fecal fatty acid profile
Time Frame: Fasting (t=0) in week 1 and week 6 of intervention
Fasting (t=0) in week 1 and week 6 of intervention

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 of 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 (Estimated)

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.
January 6, 2025

Primary Completion (Estimated)

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.
December 31, 2025

Study Completion (Estimated)

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.
December 31, 2025

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).
November 14, 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.
November 19, 2024

First Posted (Estimated)

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.
November 22, 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 22, 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.
November 19, 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.
November 1, 2024

More Information

Terms related to this study

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 2

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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