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| Name | Class |
|---|---|
| Charite University, Department for Dental Medicine | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional | Experimental | Participants receive a 8 week nutritional counseling with weekly group meetings to establish a plant-based diet. |
|
| Control | No Intervention | Waiting list. Participants receive no intervention during study period, equal intervention is offered after the end of study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant-based Diet | Other | Patients are guided to change their nutrition to a plant-based diet. |
|
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative interviews in focus groups interviews | 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. | 16 weeks after inclusion |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Michalsen, Prof. Dr. | Charite - Universitätsmedizin Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charite University | Berlin | 14109 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39402877 | Derived | Pappe CL, Lutzenberger S, Goebler K, Meier S, Jeitler M, Michalsen A, Dommisch H. Effect of a Whole-Food Plant-Based Diet on Periodontal Parameters in Patients With Cardiovascular Risk Factors: A Secondary Sub-Analysis of a Randomized Clinical Trial. J Clin Periodontol. 2025 Jan;52(1):125-136. doi: 10.1111/jcpe.14066. Epub 2024 Oct 14. |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D050177 | Overweight |
| D009765 | Obesity |
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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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 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |