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

Primary Purpose

Metabolic Syndrome, Cardiovascular Risk Factor, Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Plant-based Diet
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic Syndrom, Plant-based Diet, Nutrition

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charite University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interventional

Control

Arm Description

Participants receive a 8 week nutritional counseling with weekly group meetings to establish a plant-based diet.

Waiting list. Participants receive no intervention during study period, equal intervention is offered after the end of study.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Bio-electrical Impedance Analysis (BIA)
Estimation of the body composition via bio-electrical impedance analysis (body fat and visceral fat in %)
Bio-electrical Impedance analysis (BIA)
Estimation of the body composition via bio-electrical impedance analysis (muscle mass in kg)
Change from baseline systolic blood pressure at 2 months
Average of 24h measurement
Change from baseline diastolic blood pressure at 2 months
Average of 24h measurement
Fasting glucose (mmol/l)
Blood lipids
Triglycerides (mmol/L), total cholesterol (mmol/L), LDL (mmol/L), HDL (mmol/L)
Insulin (µU/ml)
Glycated hemoglobin (HbA1c) (%)
Fructosamin (µmol/l)
Homeostatic model assessment (HOMA-IR)
Index calculated from Insulin (µU/ml) x fasting glucose (mmol/l) / 22,5
Ferritin (µg/l)
Liver enzymes
Hepatic transaminases (GPT, GOT in U/L) and Gamma glutamyl transpeptidase (y-GT in U/L)
Folic acid (ng/ml)
Uric Acid (mg/dl)
Complete Blood Count
Holotranscobalamin (pmol/L)
Trimethylamine N-oxide (mg/dl)
Quality of Life questionnaire (WHO-5)
Change from Baseline in the WHO-5, range from 0 to 100 % while higher values meaning a higher grade of well-being
Stress questionnaire (Cohen Perceived Stress Scale, CPSS)
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.
General Self-efficacy Short Scale (ASKU)
Assessing full scale, range 3-15, higher score meaning a better outcome
Hospital Anxiety and Depression Scale (HADS)
Assessing full scale, range 0-42, lower score meaning a better outcome
Medical Outcomes Study Short Form (MOS SF-12)
Assessing full scale, range 0-100, higher score meaning a better outcome
Zerssen symptom list (B-LR and B-LR')
Assessing full scale, range 20-80, higher score meaning a better outcome
Intuitive Eating Scale 2 (IES-2)
Assessing full scale, range 23-115, higher score meaning a better outcome
Flourishing Scale (FS-D)
Assessing full scale, range 8-56, higher score meaning a better outcome
International Physical Activity Questionnaire (IPAQ )
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.
Body weight (kg)
Body Mass Index (kg/m2)
Waist circumference (cm)
Wrist Circumference (cm)
Ambulatory Blood Pressure Monitoring (ABPM)
Measuring systolic and diastolic blood pressure in 20-minute-intervals for 24h with "Spacelabs" devices
Dietary Behaviour
Nutritional history via dietary weight record (each for 3 days)
Daily nutrition protocol
Via the App 'Calorie Counter - Fddb Extender'
Medication intake
Name of medication and dosage
Cardio Vascular Risc Profile
Cardio Vascular Risc in % with following scores: SCORE-Deutschland/PROCAM/arriba/WHO-ISH Charts/BEWAT-Score
Gut microbiome
16S rRNA Sequencing / Shotgun Sequencing
Blood Oxygenization
24h measuring by Biovotion Everion (upper arm)
Skin Temperature
24h measuring by Biovotion Everion and Empatica E4 devices (upper arm/wrist)
Heart Rate (HR)
24h measuring by Faros 180 (chest), Biovotion Everion and Empatica E4 (upper arm/wrist) devices
Heart Rate Variability (HRV)
24h measuring by Faros 180 (chest), Biovotion Everion and Empatica E4 (upper arm/wrist) devices
Interbeat Interval (IBI)
24h measuring by Biovotion Everion and Empatica E4 devices (upper arm/wrist)
Respiration Rate
24h measuring by Biovotion Everion device
Blood Volume Pulse
24h measuring by Empatica E4 device (wrist)
Electrodermal Activity (Galvanic Skin Response)
24h measuring by Biovotion Everion device and Empatica E4 (upper arm/wrist) devices
Number of Steps per 24 hours
24h measuring by Biovotion Everion device (upper arm)
Sociodemographic Measurements
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
Oral Health Qualitative Interviews
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
Evaluation of inflammatory oral conditions
bleeding index (gingival bleeding index, bleeding on probing) in percentage, ranges from 0 to 100 %, optimal is less then 15 %
Evaluation of teeth related conditions
dental findings (attrition, bruxism, caries, dental implants, dentures, missing teeth, erosions, restorations (all classes))
Evaluation of Oral Fluids
crevicular fluid rate, salivary flow (stimulated, unstimulated)
Evaluation of periodontal attachment level
probing pocket depth, recessions, measuring in mm on 6 sites per tooth
Evaluation of oral hygiene
Plaque Index in %, ranges from 0 to 100%, less then 15 % Shows an optimal oral hygiene
Evaluation of periodontal status
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

Full Information

First Posted
March 28, 2019
Last Updated
September 28, 2022
Sponsor
Charite University, Berlin, Germany
Collaborators
Charite University, Department for Dental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03901183
Brief Title
Plant-based Nutrition for Patients With Cardiovascular Risk Factors
Acronym
CardioVeg
Official Title
Plant-based Nutrition for Patients With Cardiovascular Risk Factors - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 27, 2019 (Actual)
Primary Completion Date
February 11, 2021 (Actual)
Study Completion Date
February 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Charite University, Department for Dental Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Cardiovascular Risk Factor, Overweight and Obesity, Hypertension,Essential
Keywords
Metabolic Syndrom, Plant-based Diet, Nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Experimental
Arm Description
Participants receive a 8 week nutritional counseling with weekly group meetings to establish a plant-based diet.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Waiting list. Participants receive no intervention during study period, equal intervention is offered after the end of study.
Intervention Type
Other
Intervention Name(s)
Plant-based Diet
Intervention Description
Patients are guided to change their nutrition to a plant-based diet.
Primary Outcome Measure Information:
Title
Change of baseline Composite Score for Metabolic Syndrom (Standardizing Physiological Composite Risk Endpoints (SCORE)) at 2 months
Description
Composite score including waist wircumference, blood pressure, fasting blood glucose, tryglycerids, HDL-cholesterin Range 0-100, lower score meaning a better outcome
Time Frame
Date of inclusion (baseline), after 8 weeks
Secondary Outcome Measure Information:
Title
Bio-electrical Impedance Analysis (BIA)
Description
Estimation of the body composition via bio-electrical impedance analysis (body fat and visceral fat in %)
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Bio-electrical Impedance analysis (BIA)
Description
Estimation of the body composition via bio-electrical impedance analysis (muscle mass in kg)
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Change from baseline systolic blood pressure at 2 months
Description
Average of 24h measurement
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Change from baseline diastolic blood pressure at 2 months
Description
Average of 24h measurement
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Fasting glucose (mmol/l)
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Blood lipids
Description
Triglycerides (mmol/L), total cholesterol (mmol/L), LDL (mmol/L), HDL (mmol/L)
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Insulin (µU/ml)
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Glycated hemoglobin (HbA1c) (%)
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Fructosamin (µmol/l)
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Homeostatic model assessment (HOMA-IR)
Description
Index calculated from Insulin (µU/ml) x fasting glucose (mmol/l) / 22,5
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Ferritin (µg/l)
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Liver enzymes
Description
Hepatic transaminases (GPT, GOT in U/L) and Gamma glutamyl transpeptidase (y-GT in U/L)
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Folic acid (ng/ml)
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Uric Acid (mg/dl)
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Complete Blood Count
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Holotranscobalamin (pmol/L)
Time Frame
Date of inclusion (baseline), after 16 weeks
Title
Trimethylamine N-oxide (mg/dl)
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Quality of Life questionnaire (WHO-5)
Description
Change from Baseline in the WHO-5, range from 0 to 100 % while higher values meaning a higher grade of well-being
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Stress questionnaire (Cohen Perceived Stress Scale, CPSS)
Description
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.
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
General Self-efficacy Short Scale (ASKU)
Description
Assessing full scale, range 3-15, higher score meaning a better outcome
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Hospital Anxiety and Depression Scale (HADS)
Description
Assessing full scale, range 0-42, lower score meaning a better outcome
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Medical Outcomes Study Short Form (MOS SF-12)
Description
Assessing full scale, range 0-100, higher score meaning a better outcome
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Zerssen symptom list (B-LR and B-LR')
Description
Assessing full scale, range 20-80, higher score meaning a better outcome
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Intuitive Eating Scale 2 (IES-2)
Description
Assessing full scale, range 23-115, higher score meaning a better outcome
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Flourishing Scale (FS-D)
Description
Assessing full scale, range 8-56, higher score meaning a better outcome
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
International Physical Activity Questionnaire (IPAQ )
Description
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.
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Body weight (kg)
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Body Mass Index (kg/m2)
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Waist circumference (cm)
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Wrist Circumference (cm)
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Ambulatory Blood Pressure Monitoring (ABPM)
Description
Measuring systolic and diastolic blood pressure in 20-minute-intervals for 24h with "Spacelabs" devices
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Dietary Behaviour
Description
Nutritional history via dietary weight record (each for 3 days)
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Daily nutrition protocol
Description
Via the App 'Calorie Counter - Fddb Extender'
Time Frame
Daily throughout the entire survey period
Title
Medication intake
Description
Name of medication and dosage
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Cardio Vascular Risc Profile
Description
Cardio Vascular Risc in % with following scores: SCORE-Deutschland/PROCAM/arriba/WHO-ISH Charts/BEWAT-Score
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Gut microbiome
Description
16S rRNA Sequencing / Shotgun Sequencing
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Blood Oxygenization
Description
24h measuring by Biovotion Everion (upper arm)
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Skin Temperature
Description
24h measuring by Biovotion Everion and Empatica E4 devices (upper arm/wrist)
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Heart Rate (HR)
Description
24h measuring by Faros 180 (chest), Biovotion Everion and Empatica E4 (upper arm/wrist) devices
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Heart Rate Variability (HRV)
Description
24h measuring by Faros 180 (chest), Biovotion Everion and Empatica E4 (upper arm/wrist) devices
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Interbeat Interval (IBI)
Description
24h measuring by Biovotion Everion and Empatica E4 devices (upper arm/wrist)
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Respiration Rate
Description
24h measuring by Biovotion Everion device
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Blood Volume Pulse
Description
24h measuring by Empatica E4 device (wrist)
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Electrodermal Activity (Galvanic Skin Response)
Description
24h measuring by Biovotion Everion device and Empatica E4 (upper arm/wrist) devices
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Number of Steps per 24 hours
Description
24h measuring by Biovotion Everion device (upper arm)
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Sociodemographic Measurements
Description
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
Time Frame
Date of inclusion (baseline)
Title
Oral Health Qualitative Interviews
Description
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
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Evaluation of inflammatory oral conditions
Description
bleeding index (gingival bleeding index, bleeding on probing) in percentage, ranges from 0 to 100 %, optimal is less then 15 %
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Evaluation of teeth related conditions
Description
dental findings (attrition, bruxism, caries, dental implants, dentures, missing teeth, erosions, restorations (all classes))
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Evaluation of Oral Fluids
Description
crevicular fluid rate, salivary flow (stimulated, unstimulated)
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Evaluation of periodontal attachment level
Description
probing pocket depth, recessions, measuring in mm on 6 sites per tooth
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Evaluation of oral hygiene
Description
Plaque Index in %, ranges from 0 to 100%, less then 15 % Shows an optimal oral hygiene
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Title
Evaluation of periodontal status
Description
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
Time Frame
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Other Pre-specified Outcome Measures:
Title
Qualitative interviews in focus groups interviews
Description
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.
Time Frame
16 weeks after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Michalsen, Prof. Dr.
Organizational Affiliation
Charite - Universitätsmedizin Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charite University
City
Berlin
ZIP/Postal Code
14109
Country
Germany

12. IPD Sharing Statement

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Plant-based Nutrition for Patients With Cardiovascular Risk Factors

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