Plant-based Nutrition for Patients With Cardiovascular Risk Factors (CardioVeg)

September 28, 2022 updated by: Andreas Michalsen, Charite University, Berlin, Germany

Plant-based Nutrition for Patients With Cardiovascular Risk Factors - a Randomized Controlled Trial

Plant-based nutrition may have positive effects on chronic diseases such as cardiovascular or metabolic disorders. This study investigates the effects of a 8 week plant-based diet for patients with metabolic syndrom and cardiovascular risk factors.

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.

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.
70

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
      • Berlin, Germany, 14109
        • Charite University

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

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Blood pressure > 140 mmHg systolic and/or > 90 mmHg diastolic, in case of medication also increased values > 140 mmHg systolic and/or > 90 mmHg diastolic needed
  • Adipositas with a waist circumference of > 94 cm in men and > 80 cm in women
  • A non-vegetarian diet in the past 6 months (at least 4x meat and/or meat products per week, at least 5x dairy products per week)
  • No fasting, no specific diet or change of diet in the last 2 months
  • Weight stable over the last two months (+- 3 kg)
  • Medication unchanged for at least one month
  • No fasting, no change of diet in the last 2 months

Exclusion Criteria:

  • Poor general condition
  • Coronary heart disease
  • Diabetes mellitus Type I
  • Cerebrovascular diseases
  • Severe mental illness
  • Severe acute or chronic comorbidity
  • Pregnancy and lactation or planned pregnancy in the next 6 months
  • Eating disorder
  • Max. 2 beers 0,5l or 2 wines 0,2l per day
  • No alcohol abstinence 48 hours before blood samples possible
  • Max. 5 cigarettes/day
  • Medicine that affect weight
  • Antibiotics within the last 6 months
  • Major surgery <6 months prior to randomization
  • BMI > 40 kg/m2
  • Existing vegetarian or plant-based diet
  • Bariatric surgery (obesity surgery)
  • Simultaneous participation in another clinical trial
  • Participation in a clinical trial within the last 3 months prior to inclusion in the study
  • Lack of consent to participate in the study

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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: Interventional
Participants receive a 8 week nutritional counseling with weekly group meetings to establish a plant-based diet.
Other: Plant-based Diet
Patients are guided to change their nutrition to a plant-based diet.
No Intervention: Control
Waiting list. Participants receive no intervention during study period, equal intervention is offered after the end of study.

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
Change of baseline Composite Score for Metabolic Syndrom (Standardizing Physiological Composite Risk Endpoints (SCORE)) at 2 months
Time Frame: Date of inclusion (baseline), after 8 weeks
Composite score including waist wircumference, blood pressure, fasting blood glucose, tryglycerids, HDL-cholesterin Range 0-100, lower score meaning a better outcome
Date of inclusion (baseline), after 8 weeks

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
Bio-electrical Impedance Analysis (BIA)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Estimation of the body composition via bio-electrical impedance analysis (body fat and visceral fat in %)
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Bio-electrical Impedance analysis (BIA)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Estimation of the body composition via bio-electrical impedance analysis (muscle mass in kg)
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Change from baseline systolic blood pressure at 2 months
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Average of 24h measurement
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Change from baseline diastolic blood pressure at 2 months
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Average of 24h measurement
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Fasting glucose (mmol/l)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Blood lipids
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Triglycerides (mmol/L), total cholesterol (mmol/L), LDL (mmol/L), HDL (mmol/L)
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Insulin (µU/ml)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Glycated hemoglobin (HbA1c) (%)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Fructosamin (µmol/l)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Homeostatic model assessment (HOMA-IR)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Index calculated from Insulin (µU/ml) x fasting glucose (mmol/l) / 22,5
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Ferritin (µg/l)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Liver enzymes
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Hepatic transaminases (GPT, GOT in U/L) and Gamma glutamyl transpeptidase (y-GT in U/L)
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Folic acid (ng/ml)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Uric Acid (mg/dl)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Complete Blood Count
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Holotranscobalamin (pmol/L)
Time Frame: Date of inclusion (baseline), after 16 weeks
Date of inclusion (baseline), after 16 weeks
Trimethylamine N-oxide (mg/dl)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Quality of Life questionnaire (WHO-5)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Change from Baseline in the WHO-5, range from 0 to 100 % while higher values meaning a higher grade of well-being
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Stress questionnaire (Cohen Perceived Stress Scale, CPSS)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Change from Baseline in the CPSS, range from 0 to 4 in each item. Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the positively stated items and then summing across all scale items while higher values meaning a higher grade of perceived stress.
Date of inclusion (baseline), after 8 weeks, after 16 weeks
General Self-efficacy Short Scale (ASKU)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Assessing full scale, range 3-15, higher score meaning a better outcome
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Assessing full scale, range 0-42, lower score meaning a better outcome
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Medical Outcomes Study Short Form (MOS SF-12)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Assessing full scale, range 0-100, higher score meaning a better outcome
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Zerssen symptom list (B-LR and B-LR')
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Assessing full scale, range 20-80, higher score meaning a better outcome
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Intuitive Eating Scale 2 (IES-2)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Assessing full scale, range 23-115, higher score meaning a better outcome
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Flourishing Scale (FS-D)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Assessing full scale, range 8-56, higher score meaning a better outcome
Date of inclusion (baseline), after 8 weeks, after 16 weeks
International Physical Activity Questionnaire (IPAQ )
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
MET minutes represent the amount of energy expended carrying out physical activity. To get a continuous variable score from the IPAQ (MET minutes a week) we will consider walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS.
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Body weight (kg)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Body Mass Index (kg/m2)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Waist circumference (cm)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Wrist Circumference (cm)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Ambulatory Blood Pressure Monitoring (ABPM)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Measuring systolic and diastolic blood pressure in 20-minute-intervals for 24h with "Spacelabs" devices
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Dietary Behaviour
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Nutritional history via dietary weight record (each for 3 days)
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Daily nutrition protocol
Time Frame: Daily throughout the entire survey period
Via the App 'Calorie Counter - Fddb Extender'
Daily throughout the entire survey period
Medication intake
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Name of medication and dosage
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Cardio Vascular Risc Profile
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Cardio Vascular Risc in % with following scores: SCORE-Deutschland/PROCAM/arriba/WHO-ISH Charts/BEWAT-Score
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Gut microbiome
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
16S rRNA Sequencing / Shotgun Sequencing
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Blood Oxygenization
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
24h measuring by Biovotion Everion (upper arm)
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Skin Temperature
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
24h measuring by Biovotion Everion and Empatica E4 devices (upper arm/wrist)
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Heart Rate (HR)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
24h measuring by Faros 180 (chest), Biovotion Everion and Empatica E4 (upper arm/wrist) devices
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Heart Rate Variability (HRV)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
24h measuring by Faros 180 (chest), Biovotion Everion and Empatica E4 (upper arm/wrist) devices
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Interbeat Interval (IBI)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
24h measuring by Biovotion Everion and Empatica E4 devices (upper arm/wrist)
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Respiration Rate
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
24h measuring by Biovotion Everion device
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Blood Volume Pulse
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
24h measuring by Empatica E4 device (wrist)
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Electrodermal Activity (Galvanic Skin Response)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
24h measuring by Biovotion Everion device and Empatica E4 (upper arm/wrist) devices
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Number of Steps per 24 hours
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
24h measuring by Biovotion Everion device (upper arm)
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Sociodemographic Measurements
Time Frame: Date of inclusion (baseline)
Age, gender, education level, household income, employment status, marital status, language spoken, complete family history, current and previous illness and co-morbidities, and current medications
Date of inclusion (baseline)
Oral Health Qualitative Interviews
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
using the German version of the "Oral Health Impact Profile" with 21 questions, score ranges from 0 to 21, high score Shows a low Quality of oral health, low score Shows a high Quality of life
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Evaluation of inflammatory oral conditions
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
bleeding index (gingival bleeding index, bleeding on probing) in percentage, ranges from 0 to 100 %, optimal is less then 15 %
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Evaluation of teeth related conditions
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
dental findings (attrition, bruxism, caries, dental implants, dentures, missing teeth, erosions, restorations (all classes))
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Evaluation of Oral Fluids
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
crevicular fluid rate, salivary flow (stimulated, unstimulated)
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Evaluation of periodontal attachment level
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
probing pocket depth, recessions, measuring in mm on 6 sites per tooth
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Evaluation of oral hygiene
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Plaque Index in %, ranges from 0 to 100%, less then 15 % Shows an optimal oral hygiene
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Evaluation of periodontal status
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measuring with periodontal Screening index, ranges from 0 to 4, code 0 - oral health, 1-2 Gingivitis, 3-4 Periodontitis, additional findings as furcation involvement and loosening are documented
Date of inclusion (baseline), after 8 weeks, after 16 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Qualitative interviews in focus groups interviews
Time Frame: 16 weeks after inclusion
Qualitative assessment will be carried out in 45-minute focus group interviews in 12 (randomized selected) patients participating in the study. The interviews will be recorded, transcribed and analyzed with qualitative content analysis.
16 weeks after inclusion

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.
Charite University, Berlin, Germany

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.
Charite University, Department for Dental Medicine

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 27, 2019

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.
February 11, 2021

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.
February 11, 2021

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).
March 28, 2019

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.
April 1, 2019

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.
April 3, 2019

Study Record Updates

Last Update Posted (Actual)

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.
September 29, 2022

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.
September 28, 2022

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.
September 1, 2022

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.
  • CardioVeg

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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