Plant-based Nutrition for Patients With Cardiovascular Risk Factors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-27

Study Completion Date

2021-02-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Metabolic Syndrome Cardiovascular Risk Factor Overweight and Obesity Hypertension,Essential

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interventional

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

Group Type EXPERIMENTAL

Plant-based Diet

Intervention Type OTHER

Patients are guided to change their nutrition to a plant-based diet.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Plant-based Diet

Patients are guided to change their nutrition to a plant-based diet.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No