Cardiovascular Risk Factor, Hypertension,Essential, Metabolic Syndrome, Overweight and Obesity
Conditions
Keywords
Metabolic Syndrom, Plant-based Diet, Nutrition
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.
Interventions
OTHERPlant-based Diet
Patients are guided to change their nutrition to a plant-based diet.
Sponsors
Charite University, Department for Dental Medicine
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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 |
| 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 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 |
| 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 % |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Outcome results
None listed