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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Patients are guided to change their nutrition to a plant-based diet.
Charite University
Berlin, Germany
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
Time frame: Date of inclusion (baseline), after 8 weeks
Bio-electrical Impedance Analysis (BIA)
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
Bio-electrical Impedance analysis (BIA)
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
Change from baseline systolic blood pressure at 2 months
Average of 24h measurement
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Change from baseline diastolic blood pressure at 2 months
Average of 24h measurement
Time frame: 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
Blood lipids
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Insulin (µU/ml)
Time frame: 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
Fructosamin (µmol/l)
Time frame: 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
Time frame: 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
Liver enzymes
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
Folic acid (ng/ml)
Time frame: 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
Complete Blood Count
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Holotranscobalamin (pmol/L)
Time frame: Date of inclusion (baseline), after 16 weeks
Trimethylamine N-oxide (mg/dl)
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Body Mass Index (kg/m2)
Time frame: 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
Wrist Circumference (cm)
Time frame: 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
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Dietary Behaviour
Nutritional history via dietary weight record (each for 3 days)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Daily nutrition protocol
Via the App 'Calorie Counter - Fddb Extender'
Time frame: Daily throughout the entire survey period
Medication intake
Name of medication and dosage
Time frame: 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
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Gut microbiome
16S rRNA Sequencing / Shotgun Sequencing
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Blood Oxygenization
24h measuring by Biovotion Everion (upper arm)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Skin Temperature
24h measuring by Biovotion Everion and Empatica E4 devices (upper arm/wrist)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Respiration Rate
24h measuring by Biovotion Everion device
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Blood Volume Pulse
24h measuring by Empatica E4 device (wrist)
Time frame: 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
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Number of Steps per 24 hours
24h measuring by Biovotion Everion device (upper arm)
Time frame: 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
Time frame: 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
Time frame: 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 %
Time frame: 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))
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Evaluation of Oral Fluids
crevicular fluid rate, salivary flow (stimulated, unstimulated)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks