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

Charité University Medicine Berlin

Status: Completed

Conditions: Hypertension,Essential; Overweight and Obesity; Cardiovascular Risk Factor; Metabolic Syndrome

Treatments: Other: Plant-based Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03901183

CardioVeg

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Interventional

Experimental group

Description:

Participants receive a 8 week nutritional counseling with weekly group meetings to establish a plant-based diet.

Treatment:

Other: Plant-based Diet

Control

No Intervention group

Description:

Waiting list. Participants receive no intervention during study period, equal intervention is offered after the end of study.