Plant-based Nutrition for Patients With Cardiovascular Risk Factors
- Conditions
- Metabolic SyndromeOverweight and ObesityHypertension,EssentialCardiovascular Risk Factor
- Interventions
- Other: Plant-based Diet
- Registration Number
- NCT03901183
- Lead Sponsor
- Charite University, Berlin, Germany
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Interventional Plant-based Diet Participants receive a 8 week nutritional counseling with weekly group meetings to establish a plant-based diet.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 %)
Change from baseline systolic blood pressure at 2 months Date of inclusion (baseline), after 8 weeks, after 16 weeks Average of 24h measurement
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)
Ferritin (µg/l) Date of inclusion (baseline), after 8 weeks, after 16 weeks Holotranscobalamin (pmol/L) Date of inclusion (baseline), 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
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
Body Mass Index (kg/m2) Date of inclusion (baseline), after 8 weeks, after 16 weeks 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)
Fructosamin (µmol/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 Complete Blood Count Date of inclusion (baseline), after 8 weeks, after 16 weeks Trimethylamine N-oxide (mg/dl) Date of inclusion (baseline), after 8 weeks, after 16 weeks 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 Glycated hemoglobin (HbA1c) (%) Date of inclusion (baseline), after 8 weeks, after 16 weeks Uric Acid (mg/dl) Date of inclusion (baseline), after 8 weeks, after 16 weeks 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.
Insulin (µU/ml) 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
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
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
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
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
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
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.
Medication intake Date of inclusion (baseline), after 8 weeks, after 16 weeks Name of medication and dosage
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)
Body weight (kg) Date of inclusion (baseline), after 8 weeks, after 16 weeks Daily nutrition protocol Daily throughout the entire survey period Via the App 'Calorie Counter - Fddb Extender'
Dietary Behaviour Date of inclusion (baseline), after 8 weeks, after 16 weeks Nutritional history via dietary weight record (each for 3 days)
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
Number of Steps per 24 hours Date of inclusion (baseline), after 8 weeks, after 16 weeks 24h measuring by Biovotion Everion device (upper arm)
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 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
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
Skin Temperature Date of inclusion (baseline), after 8 weeks, after 16 weeks 24h measuring by Biovotion Everion and Empatica E4 devices (upper arm/wrist)
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)
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
Respiration Rate Date of inclusion (baseline), after 8 weeks, after 16 weeks 24h measuring by Biovotion Everion device
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 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
Trial Locations
- Locations (1)
Charite University
🇩🇪Berlin, Germany