CardioVeg: Plant-based Nutrition for Patients With Cardiovascular Risk Factors

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03901183

Collaborator

Charite University, Department for Dental Medicine (Other)

Enrollment

Location

Arms

30.2

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome Cardiovascular Risk Factor Overweight and Obesity Hypertension,Essential	Other: Plant-based Diet	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 27, 2019

Actual Primary Completion Date :

Feb 11, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Change of baseline Composite Score for Metabolic Syndrom (Standardizing Physiological Composite Risk Endpoints (SCORE)) at 2 months [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

Secondary Outcome Measures

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

Other Outcome Measures

Qualitative interviews in focus groups interviews [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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