Clinical trial NCT03901183: Plant-based Nutrition for Patients With Cardiovascular Risk Factors
Official title: Plant-based Nutrition for Patients With Cardiovascular Risk Factors - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Cardiovascular Risk Factor
Overweight and Obesity
Hypertension,Essential
Keywords: Metabolic Syndrom
Plant-based Diet
Nutrition
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Charite University, Department for Dental Medicine
First posted: 2019-04-03
Enrollment: 70
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Change of baseline Composite Score for Metabolic Syndrom (Standardizing Physiological Composite Risk Endpoints (SCORE)) at 2 months
timeFrame: Date of inclusion (baseline), after 8 weeks
Secondary outcomes:
measure: Bio-electrical Impedance Analysis (BIA)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Bio-electrical Impedance analysis (BIA)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Change from baseline systolic blood pressure at 2 months
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Change from baseline diastolic blood pressure at 2 months
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Fasting glucose (mmol/l)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Blood lipids
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Insulin (µU/ml)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Glycated hemoglobin (HbA1c) (%)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Fructosamin (µmol/l)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Homeostatic model assessment (HOMA-IR)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Ferritin (µg/l)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Liver enzymes
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Folic acid (ng/ml)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Uric Acid (mg/dl)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Complete Blood Count
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Holotranscobalamin (pmol/L)
timeFrame: Date of inclusion (baseline), after 16 weeks
measure: Trimethylamine N-oxide (mg/dl)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Quality of Life questionnaire (WHO-5)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Stress questionnaire (Cohen Perceived Stress Scale, CPSS)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: General Self-efficacy Short Scale (ASKU)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Medical Outcomes Study Short Form (MOS SF-12)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Zerssen symptom list (B-LR and B-LR')
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Intuitive Eating Scale 2 (IES-2)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Flourishing Scale (FS-D)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: International Physical Activity Questionnaire (IPAQ )
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Body weight (kg)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Body Mass Index (kg/m2)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Waist circumference (cm)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Wrist Circumference (cm)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Ambulatory Blood Pressure Monitoring (ABPM)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Dietary Behaviour
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Daily nutrition protocol
timeFrame: Daily throughout the entire survey period
measure: Medication intake
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Cardio Vascular Risc Profile
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Gut microbiome
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Blood Oxygenization
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Skin Temperature
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Heart Rate (HR)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Heart Rate Variability (HRV)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Interbeat Interval (IBI)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Respiration Rate
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Blood Volume Pulse
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Electrodermal Activity (Galvanic Skin Response)
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Number of Steps per 24 hours
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Sociodemographic Measurements
timeFrame: Date of inclusion (baseline)
measure: Oral Health Qualitative Interviews
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Evaluation of inflammatory oral conditions
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Evaluation of teeth related conditions
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Evaluation of Oral Fluids
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Evaluation of periodontal attachment level
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Evaluation of oral hygiene
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
measure: Evaluation of periodontal status
timeFrame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Other outcomes:
measure: Qualitative interviews in focus groups interviews
timeFrame: 16 weeks after inclusion
Locations:
city: Berlin
country: Germany
facility: Charite University
Study officials:
affiliation: Charite - Universitätsmedizin Berlin
name: Andreas Michalsen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: