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

Charite University, Berlin, Germany1 site in 1 country70 target enrollmentMay 27, 2019

ConditionsMetabolic Syndrome Cardiovascular Risk Factor Overweight and Obesity Hypertension,Essential

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Metabolic Syndrome
Sponsor: Charite University, Berlin, Germany
Enrollment: 70
Locations: 1
Primary Endpoint: Change of baseline Composite Score for Metabolic Syndrom (Standardizing Physiological Composite Risk Endpoints (SCORE)) at 2 months
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 27, 2019

End Date

February 11, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Charite University, Berlin, Germany

Responsible Party

Principal Investigator

Andreas Michalsen

Prof. Dr. med.

Charite University, Berlin, Germany

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change of baseline Composite Score for Metabolic Syndrom (Standardizing Physiological Composite Risk Endpoints (SCORE)) at 2 months

Time Frame: 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 Outcomes

Bio-electrical Impedance Analysis (BIA)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
Change from baseline systolic blood pressure at 2 months(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
Blood lipids(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
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)
General Self-efficacy Short Scale (ASKU)(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)
Bio-electrical Impedance analysis (BIA)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
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)
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)
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)
Waist circumference (cm)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
Flourishing Scale (FS-D)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
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)
Zerssen symptom list (B-LR and B-LR')(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)
Hospital Anxiety and Depression Scale (HADS)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
Medical Outcomes Study Short Form (MOS SF-12)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
Intuitive Eating Scale 2 (IES-2)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
International Physical Activity Questionnaire (IPAQ )(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
Medication intake(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
Gut microbiome(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
Blood Oxygenization(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
Body weight (kg)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
Daily nutrition protocol(Daily throughout the entire survey period)
Dietary Behaviour(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
Heart Rate (HR)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
Heart Rate Variability (HRV)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
Number of Steps per 24 hours(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
Evaluation of inflammatory oral conditions(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
Evaluation of teeth related conditions(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
Evaluation of Oral Fluids(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
Evaluation of periodontal status(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
Cardio Vascular Risc Profile(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
Skin Temperature(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
Interbeat Interval (IBI)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
Blood Volume Pulse(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
Electrodermal Activity (Galvanic Skin Response)(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
Respiration Rate(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
Sociodemographic Measurements(Date of inclusion (baseline))
Oral Health Qualitative Interviews(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
Evaluation of periodontal attachment level(Date of inclusion (baseline), after 8 weeks, after 16 weeks)
Evaluation of oral hygiene(Date of inclusion (baseline), after 8 weeks, after 16 weeks)