Metabolic SyndromeCardioVegNCT03901183
Plant-based Nutrition for Patients With Cardiovascular Risk Factors
A study testing Plant-based Diet in people with Metabolic Syndrome and Cardiovascular Risk Factor, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Metabolic Syndrome, Cardiovascular Risk Factor, Overweight and Obesity
- What is being tested?
- Plant-based Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- 27 May 2019to 11 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Poor general condition
- Coronary heart disease
- Diabetes mellitus Type I
- Cerebrovascular diseases
- Severe mental illness
- Severe acute or chronic comorbidity
Show all 20Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Plant-based Nutrition for Patients With Cardiovascular Risk Factors - a Randomized Controlled Trial
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
- Being tested
- Plant-based Diet
- Keywords
- Metabolic Syndrom, Plant-based Diet, Nutrition
- Medical subject headings
- Metabolic Syndrome, Overweight, Obesity, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-based DietOther
Patients are guided to change their nutrition to a plant-based diet.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Participants receive a 8 week nutritional counseling with weekly group meetings to establish a plant-based diet. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Date of inclusion (baseline), after 8 weeks
Secondary outcomes (53)
Bio-electrical Impedance Analysis (BIA)
Estimation of the body composition via bio-electrical impedance analysis (body fat and visceral fat in %)
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Bio-electrical Impedance analysis (BIA)
Estimation of the body composition via bio-electrical impedance analysis (muscle mass in kg)
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Change from baseline systolic blood pressure at 2 months
Average of 24h measurement
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Change from baseline diastolic blood pressure at 2 months
Average of 24h measurement
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Fasting glucose (mmol/l)
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Blood lipids
Triglycerides (mmol/L), total cholesterol (mmol/L), LDL (mmol/L), HDL (mmol/L)
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Insulin (µU/ml)
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Glycated hemoglobin (HbA1c) (%)
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Fructosamin (µmol/l)
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Homeostatic model assessment (HOMA-IR)
Index calculated from Insulin (µU/ml) x fasting glucose (mmol/l) / 22,5
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Ferritin (µg/l)
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Liver enzymes
Hepatic transaminases (GPT, GOT in U/L) and Gamma glutamyl transpeptidase (y-GT in U/L)
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Folic acid (ng/ml)
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Uric Acid (mg/dl)
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Complete Blood Count
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Holotranscobalamin (pmol/L)
Measured: Date of inclusion (baseline), after 16 weeks
Trimethylamine N-oxide (mg/dl)
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Quality of Life questionnaire (WHO-5)
Change from Baseline in the WHO-5, range from 0 to 100 % while higher values meaning a higher grade of well-being
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Stress questionnaire (Cohen Perceived Stress Scale, CPSS)
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.
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
General Self-efficacy Short Scale (ASKU)
Assessing full scale, range 3-15, higher score meaning a better outcome
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Hospital Anxiety and Depression Scale (HADS)
Assessing full scale, range 0-42, lower score meaning a better outcome
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Medical Outcomes Study Short Form (MOS SF-12)
Assessing full scale, range 0-100, higher score meaning a better outcome
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Zerssen symptom list (B-LR and B-LR')
Assessing full scale, range 20-80, higher score meaning a better outcome
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Intuitive Eating Scale 2 (IES-2)
Assessing full scale, range 23-115, higher score meaning a better outcome
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Flourishing Scale (FS-D)
Assessing full scale, range 8-56, higher score meaning a better outcome
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
International Physical Activity Questionnaire (IPAQ )
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.
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Body weight (kg)
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Body Mass Index (kg/m2)
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Waist circumference (cm)
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Wrist Circumference (cm)
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Ambulatory Blood Pressure Monitoring (ABPM)
Measuring systolic and diastolic blood pressure in 20-minute-intervals for 24h with "Spacelabs" devices
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Dietary Behaviour
Nutritional history via dietary weight record (each for 3 days)
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Daily nutrition protocol
Via the App 'Calorie Counter - Fddb Extender'
Measured: Daily throughout the entire survey period
Medication intake
Name of medication and dosage
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Cardio Vascular Risc Profile
Cardio Vascular Risc in % with following scores: SCORE-Deutschland/PROCAM/arriba/WHO-ISH Charts/BEWAT-Score
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Gut microbiome
16S rRNA Sequencing / Shotgun Sequencing
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Blood Oxygenization
24h measuring by Biovotion Everion (upper arm)
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Skin Temperature
24h measuring by Biovotion Everion and Empatica E4 devices (upper arm/wrist)
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Heart Rate (HR)
24h measuring by Faros 180 (chest), Biovotion Everion and Empatica E4 (upper arm/wrist) devices
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Heart Rate Variability (HRV)
24h measuring by Faros 180 (chest), Biovotion Everion and Empatica E4 (upper arm/wrist) devices
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Interbeat Interval (IBI)
24h measuring by Biovotion Everion and Empatica E4 devices (upper arm/wrist)
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Respiration Rate
24h measuring by Biovotion Everion device
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Blood Volume Pulse
24h measuring by Empatica E4 device (wrist)
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Electrodermal Activity (Galvanic Skin Response)
24h measuring by Biovotion Everion device and Empatica E4 (upper arm/wrist) devices
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Number of Steps per 24 hours
24h measuring by Biovotion Everion device (upper arm)
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Sociodemographic Measurements
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
Measured: Date of inclusion (baseline)
Oral Health Qualitative Interviews
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
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Evaluation of inflammatory oral conditions
bleeding index (gingival bleeding index, bleeding on probing) in percentage, ranges from 0 to 100 %, optimal is less then 15 %
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Evaluation of teeth related conditions
dental findings (attrition, bruxism, caries, dental implants, dentures, missing teeth, erosions, restorations (all classes))
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Evaluation of Oral Fluids
crevicular fluid rate, salivary flow (stimulated, unstimulated)
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Evaluation of periodontal attachment level
probing pocket depth, recessions, measuring in mm on 6 sites per tooth
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Evaluation of oral hygiene
Plaque Index in %, ranges from 0 to 100%, less then 15 % Shows an optimal oral hygiene
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Evaluation of periodontal status
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
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start27 May 2019
- Primary completion11 Feb 2021
- Study completion11 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Department for Dental Medicine
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
- Investigators
- Andreas Michalsen, Prof. Dr., Principal investigator, Charite - Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901183
- Sponsor's protocol ID
- CardioVeg
- Acronym
- CardioVeg
- Status last verified
- Sep 2022
- First submitted
- 28 Mar 2019
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39402877
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plant-based Nutrition for Patients With Cardiovascular Risk Factors - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03901183
- Acronym / sponsor ID
- CardioVeg / CardioVeg
- Conditions
- Metabolic Syndrome, Cardiovascular Risk Factor, Overweight and Obesity, Hypertension,Essential
- Keywords
- Metabolic Syndrom, Plant-based Diet, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Charite University, Department for Dental Medicine
- Study start
- 27 May 2019 (actual)
- Primary completion
- 11 Feb 2021 (actual)
- Study completion
- 11 Feb 2021 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Other: Plant-based DietParticipants receive a 8 week nutritional counseling with weekly group meetings to establish a plant-based diet. |
| Control | No intervention | –Waiting list. Participants receive no intervention during study period, equal intervention is offered after the end of study. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (20 listed)
- Poor general condition
- Coronary heart disease
- Diabetes mellitus Type I
- Cerebrovascular diseases
- Severe mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant-based DietPatients are guided to change their nutrition to a plant-based diet. | Other | Interventional |
Primary outcome
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
53 secondary outcomes
Bio-electrical Impedance Analysis (BIA)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Bio-electrical Impedance analysis (BIA)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Change from baseline systolic blood pressure at 2 months
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Change from baseline diastolic blood pressure at 2 months
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Fasting glucose (mmol/l)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Blood lipids
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Insulin (µU/ml)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Glycated hemoglobin (HbA1c) (%)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Fructosamin (µmol/l)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Homeostatic model assessment (HOMA-IR)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Ferritin (µg/l)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Liver enzymes
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Folic acid (ng/ml)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Uric Acid (mg/dl)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Complete Blood Count
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Holotranscobalamin (pmol/L)
Time frame: Date of inclusion (baseline), after 16 weeks
Trimethylamine N-oxide (mg/dl)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Quality of Life questionnaire (WHO-5)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Stress questionnaire (Cohen Perceived Stress Scale, CPSS)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
General Self-efficacy Short Scale (ASKU)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Medical Outcomes Study Short Form (MOS SF-12)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Zerssen symptom list (B-LR and B-LR')
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Intuitive Eating Scale 2 (IES-2)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Flourishing Scale (FS-D)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
International Physical Activity Questionnaire (IPAQ )
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Body weight (kg)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Body Mass Index (kg/m2)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Waist circumference (cm)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Wrist Circumference (cm)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Ambulatory Blood Pressure Monitoring (ABPM)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Dietary Behaviour
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Daily nutrition protocol
Time frame: Daily throughout the entire survey period
Medication intake
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Cardio Vascular Risc Profile
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Gut microbiome
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Blood Oxygenization
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Skin Temperature
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Heart Rate (HR)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Heart Rate Variability (HRV)
Time frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Derived from this study: PubMed 39402877Pappe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Michalsen, Prof. Dr. principal investigator
Charite - Universitätsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant-based Diet in people with Metabolic Syndrome and Cardiovascular Risk Factor, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03901183, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.