Plant-based Nutrition for Patients With Cardiovascular Risk Factors (CardioVeg)

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Overweight and Obesity; Cardiovascular Risk Factor; Hypertension,Essential
• Intervention / Treatment: Other: Plant-based Diet

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14109
    • Charité University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional; Participants receive a 8 week nutritional counseling with weekly group meetings to establish a plant-based diet.	Other: Plant-based Diet; Patients are guided to change their nutrition to a plant-based diet.
No Intervention: Control; Waiting list. Participants receive no intervention during study period, equal intervention is offered after the end of study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Charite University, Department for Dental Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2019
• Primary Completion (Actual): February 11, 2021
• Study Completion (Actual): February 11, 2021

Study Registration Dates

• First Submitted: March 28, 2019
• First Submitted That Met QC Criteria: April 1, 2019
• First Posted (Actual): April 3, 2019

Study Record Updates

• Last Update Posted (Actual): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Nutrition; Metabolic Syndrom; Plant-based Diet
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Body Weight; Insulin Resistance; Hyperinsulinism; Hypertension; Metabolic Syndrome; Overweight; Essential Hypertension
• Other Study ID Numbers: CardioVeg

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No