Plant-based Nutrition for Patients With Cardiovascular Risk Factors

NCT03901183 | Completed

• 1 other identifier: CardioVeg
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Metabolic Syndrom; Plant-based Diet; Nutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (53)

• Bio-electrical Impedance Analysis (BIA)

  Date of inclusion (baseline), after 8 weeks, after 16 weeks

• Bio-electrical Impedance analysis (BIA)

  Date of inclusion (baseline), after 8 weeks, after 16 weeks

• Change from baseline systolic blood pressure at 2 months

  Date of inclusion (baseline), after 8 weeks, after 16 weeks

• Change from baseline diastolic blood pressure at 2 months

  Date of inclusion (baseline), after 8 weeks, after 16 weeks

• Fasting glucose (mmol/l)

  Date of inclusion (baseline), after 8 weeks, after 16 weeks

Other Outcomes (1)

• Qualitative interviews in focus groups interviews

  16 weeks after inclusion

Study Arms (2)

Interventional

EXPERIMENTAL

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

Other: Plant-based Diet

Control

NO INTERVENTION

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

Interventions

Plant-based Diet OTHER

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

Interventional

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Charite University, Department for Dental Medicine: collaborator

Study Sites (1)

Charite University

Berlin, 14109, Germany

Location

Related Publications (1)

• Pappe CL, Lutzenberger S, Goebler K, Meier S, Jeitler M, Michalsen A, Dommisch H. Effect of a Whole-Food Plant-Based Diet on Periodontal Parameters in Patients With Cardiovascular Risk Factors: A Secondary Sub-Analysis of a Randomized Clinical Trial. J Clin Periodontol. 2025 Jan;52(1):125-136. doi: 10.1111/jcpe.14066. Epub 2024 Oct 14.

  PMID: 39402877 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Overweight; Obesity; Essential Hypertension

Interventions

Diet, Plant-Based

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Andreas Michalsen, Prof. Dr.

  Charite - Universitätsmedizin Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 3, 2019
• Study Start: May 27, 2019
• Primary Completion: February 11, 2021
• Study Completion: February 11, 2021
• Last Updated: September 29, 2022

Record last verified: 2022-09

Locations

DE (1)