Plant-based Nutrition for Patients With Cardiovascular Risk Factors (NCT03901183) | Clinical Trial Compass
CompletedNot Applicable
Plant-based Nutrition for Patients With Cardiovascular Risk Factors
Germany70 participantsStarted 2019-05-27
Plain-language 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.
Who can participate
Age range25 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
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