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Completed

NCT Number: NCT03901183

Plant-based Nutrition for Patients With Cardiovascular Risk Factors

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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Key information

Conditions

Metabolic Syndrome Body Weight Cardiovascular Diseases Cardiovascular Risk Factor Essential Hypertension Glucose Metabolism Disorders Hyperinsulinism Hypertension Hypertension,Essential Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charite University

Berlin, 14109, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plant-Based Diet

Other

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

Primary outcomes

  1. Change of baseline Composite Score for Metabolic Syndrom (Standardizing Physiological Composite Risk Endpoints (SCORE)) at 2 months

    Time frame: Date of inclusion (baseline), after 8 weeks

    Composite score including waist wircumference, blood pressure, fasting blood glucose, tryglycerids, HDL-cholesterin Range 0-100, lower score meaning a better outcome

Secondary outcomes

  1. Bio-electrical Impedance Analysis (BIA)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    Estimation of the body composition via bio-electrical impedance analysis (body fat and visceral fat in %)

  2. Bio-electrical Impedance analysis (BIA)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    Estimation of the body composition via bio-electrical impedance analysis (muscle mass in kg)

  3. Change from baseline systolic blood pressure at 2 months

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    Average of 24h measurement

  4. Change from baseline diastolic blood pressure at 2 months

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    Average of 24h measurement

  5. Fasting glucose (mmol/l)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

  6. Blood lipids

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    Triglycerides (mmol/L), total cholesterol (mmol/L), LDL (mmol/L), HDL (mmol/L)

  7. Insulin (µU/ml)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

  8. Glycated hemoglobin (HbA1c) (%)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

  9. Fructosamin (µmol/l)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

  10. Homeostatic model assessment (HOMA-IR)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    Index calculated from Insulin (µU/ml) x fasting glucose (mmol/l) / 22,5

  11. Ferritin (µg/l)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

  12. Liver enzymes

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    Hepatic transaminases (GPT, GOT in U/L) and Gamma glutamyl transpeptidase (y-GT in U/L)

  13. Folic acid (ng/ml)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

  14. Uric Acid (mg/dl)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

  15. Complete Blood Count

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

  16. Holotranscobalamin (pmol/L)

    Time frame: Date of inclusion (baseline), after 16 weeks

  17. Trimethylamine N-oxide (mg/dl)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

  18. Quality of Life questionnaire (WHO-5)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    Change from Baseline in the WHO-5, range from 0 to 100 % while higher values meaning a higher grade of well-being

  19. Stress questionnaire (Cohen Perceived Stress Scale, CPSS)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    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.

  20. General Self-efficacy Short Scale (ASKU)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    Assessing full scale, range 3-15, higher score meaning a better outcome

  21. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    Assessing full scale, range 0-42, lower score meaning a better outcome

  22. Medical Outcomes Study Short Form (MOS SF-12)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    Assessing full scale, range 0-100, higher score meaning a better outcome

  23. Zerssen symptom list (B-LR and B-LR')

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    Assessing full scale, range 20-80, higher score meaning a better outcome

  24. Intuitive Eating Scale 2 (IES-2)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    Assessing full scale, range 23-115, higher score meaning a better outcome

  25. Flourishing Scale (FS-D)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    Assessing full scale, range 8-56, higher score meaning a better outcome

  26. International Physical Activity Questionnaire (IPAQ )

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    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.

  27. Body weight (kg)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

  28. Body Mass Index (kg/m2)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

  29. Waist circumference (cm)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

  30. Wrist Circumference (cm)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

  31. Ambulatory Blood Pressure Monitoring (ABPM)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    Measuring systolic and diastolic blood pressure in 20-minute-intervals for 24h with "Spacelabs" devices

  32. Dietary Behaviour

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    Nutritional history via dietary weight record (each for 3 days)

  33. Daily nutrition protocol

    Time frame: Daily throughout the entire survey period

    Via the App 'Calorie Counter - Fddb Extender'

  34. Medication intake

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    Name of medication and dosage

  35. Cardio Vascular Risc Profile

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    Cardio Vascular Risc in % with following scores: SCORE-Deutschland/PROCAM/arriba/WHO-ISH Charts/BEWAT-Score

  36. Gut microbiome

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    16S rRNA Sequencing / Shotgun Sequencing

  37. Blood Oxygenization

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    24h measuring by Biovotion Everion (upper arm)

  38. Skin Temperature

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    24h measuring by Biovotion Everion and Empatica E4 devices (upper arm/wrist)

  39. Heart Rate (HR)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    24h measuring by Faros 180 (chest), Biovotion Everion and Empatica E4 (upper arm/wrist) devices

  40. Heart Rate Variability (HRV)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    24h measuring by Faros 180 (chest), Biovotion Everion and Empatica E4 (upper arm/wrist) devices

  41. Interbeat Interval (IBI)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    24h measuring by Biovotion Everion and Empatica E4 devices (upper arm/wrist)

  42. Respiration Rate

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    24h measuring by Biovotion Everion device

  43. Blood Volume Pulse

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    24h measuring by Empatica E4 device (wrist)

  44. Electrodermal Activity (Galvanic Skin Response)

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    24h measuring by Biovotion Everion device and Empatica E4 (upper arm/wrist) devices

  45. Number of Steps per 24 hours

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    24h measuring by Biovotion Everion device (upper arm)

  46. Sociodemographic Measurements

    Time frame: Date of inclusion (baseline)

    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

  47. Oral Health Qualitative Interviews

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    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

  48. Evaluation of inflammatory oral conditions

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    bleeding index (gingival bleeding index, bleeding on probing) in percentage, ranges from 0 to 100 %, optimal is less then 15 %

  49. Evaluation of teeth related conditions

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    dental findings (attrition, bruxism, caries, dental implants, dentures, missing teeth, erosions, restorations (all classes))

  50. Evaluation of Oral Fluids

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    crevicular fluid rate, salivary flow (stimulated, unstimulated)

  51. Evaluation of periodontal attachment level

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    probing pocket depth, recessions, measuring in mm on 6 sites per tooth

  52. Evaluation of oral hygiene

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    Plaque Index in %, ranges from 0 to 100%, less then 15 % Shows an optimal oral hygiene

  53. Evaluation of periodontal status

    Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks

    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

Other outcomes

  1. Qualitative interviews in focus groups interviews

    Time frame: 16 weeks after inclusion

    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.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Charite University, Department for Dental Medicine

Registry information

Official study title

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

Acronym: CardioVeg

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 3, 2019
Registry last updated
Sep 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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