Plant-based Nutrition for Patients With Cardiovascular Risk Factors

Study Overview
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Brief Summary
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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.

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

Conditions
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Metabolic Syndrome, Cardiovascular Risk Factor, Overweight and Obesity, Hypertension,Essential

Intervention / Treatment
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* Other: Plant-based Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Date of inclusion (baseline), after 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bio-electrical Impedance Analysis (BIA) | 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) | 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 | Average of 24h measurement | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 
| Change from baseline diastolic blood pressure at 2 months | Average of 24h measurement | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 
| Fasting glucose (mmol/l) |  | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 
| Blood lipids | 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) |  | 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) | 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) |  | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 
| Liver enzymes | 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) |  | 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) | 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) | 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) | 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) | 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) | 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') | 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) | 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) | 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 ) | 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) |  | 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) | 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 | Nutritional history via dietary weight record (each for 3 days) | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 
| Daily nutrition protocol | Via the App 'Calorie Counter - Fddb Extender' | Daily throughout the entire survey period | 
| Medication intake | Name of medication and dosage | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 
| Cardio Vascular Risc Profile | 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 | 16S rRNA Sequencing / Shotgun Sequencing | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 
| Blood Oxygenization | 24h measuring by Biovotion Everion (upper arm) | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 
| Skin Temperature | 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) | 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) | 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) | 24h measuring by Biovotion Everion and Empatica E4 devices (upper arm/wrist) | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 
| Respiration Rate | 24h measuring by Biovotion Everion device | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 
| Blood Volume Pulse | 24h measuring by Empatica E4 device (wrist) | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 
| Electrodermal Activity (Galvanic Skin Response) | 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 | 24h measuring by Biovotion Everion device (upper arm) | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 
| 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 | Date of inclusion (baseline) | 
| 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 | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 
| 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 % | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 
| Evaluation of teeth related conditions | 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 | crevicular fluid rate, salivary flow (stimulated, unstimulated) | Date of inclusion (baseline), after 8 weeks, after 16 weeks | 
| Evaluation of periodontal attachment level | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic Syndrom, Plant-based Diet, Nutrition