Obesity and OverweightVEGPREVNCT06886490
Plant-based Diets and Body Weight and Selected Metabolic Parameters Management in Obese Patients.
A study testing Mediterranean diet, Planetary diet and Lactovegetarian diet in people with Obesity and Overweight and Dietary Intervention, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The aim of the study is to determine the optimal plant-based dietary model in terms of weight loss and health that would be both acceptable and environmentally friendly dietary model based on limiting the consumption of meat and animal products. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity and Overweight, Dietary Intervention, Vegetarian Diet
- What is being tested?
- Mediterranean diet, Planetary diet and Lactovegetarian diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2023to 18 Dec 2024
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age >18 years (adults able to give informed consent to participate in the study) ≤ 60 years of age
- BMI >30 kg/m2 or BMI 25-29.9 kg/m2 with waist circumference in women 88 cm, in men 94cm.
Who cannot join
- age <18 years and >60 years,
- severe medical conditions, including alcoholism, major and extensive surgery, chronic kidney and liver disease, history of myocardial infarction, unstable angina pectoris within the last 6 months, history of stroke within the last 6 months, cancer within the last 5 years,
- psychiatric condition preventing participation in the study and cooperation with the investigators,
- use of enteral or parenteral nutrition,
- use of medications that cause significant weight loss (e.g., GLP-1 analogues)
- pregnancy or breast feeding,
- attempts to change dietary habits, including reduction of caloric intake and elimination of meat and animal products in the past 6 months,
- lack of consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Social Medicine and Public Health, Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-106
About this study
Official title: Effects of Plant-based Diets on Body Weight and Selected Metabolic Parameters in Obese Patients: a Randomised Controlled Trial of Five Different Diets
The aim of the study is to determine the optimal plant-based dietary model in terms of weight loss and health that would be both acceptable and environmentally friendly dietary model based on limiting the consumption of meat and animal products. Such findings will lead to new knowledge and allow us to formulate new principles for the nutritional treatment of people suffering from obesity.
Read the detailed description
Obesity is not only one of the most serious health problems in the world, it is also associated with an increased risk of many other diseases. Despite many preventive measures, the number of people suffering from obesity is constantly increasing, also in Poland. One of the integral elements of treatment is a change in lifestyle, including a change in eating habits. In this context, new dietary models are constantly being considered and eagerly adopted by patients. These are not always rational and evidence-based choices. What's more, what we eat is not only important for our health, but also for the planet. Recently, high-fat diets with a significant carbon footprint have gained popularity.
It is therefore worth considering more plant-based dietary models in the treatment of obesity and its associated disorders. Such a change can simultaneously help reduce greenhouse gas emissions and improve environmental quality, as well as benefit our health - both directly and indirectly.
There is a growing body of scientific evidence suggesting that limiting meat consumption may be beneficial to health, leading to weight loss, improvements in selected cardiovascular risk parameters and inflammation. However, many questions remain.
For this reason, more plant-based dietary patterns are worth considering in the treatment of obesity and its accompanying disorders. There is growing scientific evidence that limiting meat consumption promotes good health. It has been shown that the implementation of a vegetarian diet can result in weight loss, as well as help in maintaining optimal weight levels more effectively in the long term. This is extremely important for people suffering from obesity. Adherence to meat-restricted diets is also associated with other health benefits, which include an improved lipid profile and other cardiovascular risk parameters, as well as beneficial effects on inflammation and oxidative stress parameters.
Currently, there are only a few intervention studies available that have investigated the effectiveness of plant-based diets in a population of obese adults who previously have not restricted their meat consumption. Most of the studies concern vegetarians, whose awareness of taking care of their diet and lifestyle is, after all, much higher. To some extent, this may explain such optimistic conclusions from observational studies. It is not the only issue associated with research focused on plant-based diets. In experimental studies, the results of dietary interventions are very often compared with no intervention whatsoever. It would therefore be interesting to verify the effectiveness of a vegan or vegetarian diet against current dietary recommendations or another health-promoting dietary pattern - the Mediterranean diet. After all, vegan or vegetarian diets are elimination diets. Should they be recommended for the treatment of obesity and disorders associated with it? Do body weight, cholesterol and glucose levels decrease faster? What risks do they entail and are they difficult to implement? The investigators only know the answers to some of these questions.
In light of the above facts, the study will aim to evaluate the efficacy of the following plant-based diets: (1) the Mediterranean diet, (2) the 'planetary diet' as defined in the EAT-Lancet Commission report (3), the lactovegetarian diet, and (4) the vegan diet, in terms of weight reduction and effects on selected metabolic factors among obese patients. The last group (5) will receive the current national dietary recommendations for the Polish population.
To the investigators best knowledge, this is the first such study in Poland comparing several different plant-based diets. The investigators plan to recruit 100 obese adults under 60 years of age. The cohort will be randomly divided into five groups, each receiving a different intervention for 12 weeks. After 12 to 14 weeks from the end of the intervention, a follow-up meeting will take place again (i.e. after 24 to 26 weeks from the start of the nutritional intervention).
The study collect socio-demographic data and information on lifestyle (including dietary habits, physical activity, substance use and diet supplementation), psychological questionnaires (Perception of their own ability to change their diet (personality resources), which will be determined by the intensity of self-efficacy (GSES scale); Positive attitude towards the future, which will be determined by assessing the intensity of optimism (LOT-R); Coping dealing with emotions, which will be determined by assessing emotional control (CECS emotional control scale); Human ability to respond flexibly to changing situation requirements (stress, conflict, uncertainty), which will be determined by use The Brief Resilience Coping Scale (BRCS) created by V. G. and K. Sinclair A. Wallston) and to carry out biochemical tests and anthropometric measurements. Patients will be given dietary recommendations appropriate to the diet and specially designed dietary schemes, the main element to be intervened upon being the frequency of consumption of meat and other animal products or their elimination. In addition, an average carbon footprint will be estimated for each diet. Meetings with the dietitian will take place in a hybrid format (face-to-face and on-line). Venous blood for biochemical testing will be collected from patients before and after the study and at week 6 of the intervention. At the same time, anthropometric measurements will also be taken and information on wellbeing or difficulties in meeting dietary recommendations will be recorded. The investigators plan to examine the effects of the intervention on changes in body weight, body composition, blood pressure and, among others, changes in total cholesterol, LDL fraction, HDL fraction, changes in triacylglycerols, blood glucose, insulin, reduction in blood uric acid or changes in ALT, AST, GGTP activity.
Also, biochemical tests will be performed, including tests for inflammatory parameters (C-reactive protein (CRP), interleukin-6 (IL-6), L-selectin, intercellular adhesion molecule-1 (ICAM-1), and adiponectin), as well as anthropometric measurements and body composition assessments based on electrical bioimpedance. TMAO concentrations will be examined in relation to selected appetite traits. In addition, metabolites and cofactors of the methionine cycle (S-(5'-Adenosyl)-L-homocysteine (SAH), homocysteine, methionine, S-(5'-Adenosyl)-L-methionine (SAM), choline, betaine) will be monitored. In addition, selected polymorphisms of genes related to the homocysteine-methionine cycle and lipid metabolism will be evaluated. Patients will be given dietary recommendations according to their dietary habits, with the frequency of consumption or elimination of meat and other zoonotic products and their products as the main intervention element. Meetings with the dietitian will be held at baseline, week 6 and week 12. Between meetings, weekly online visits with a psychodietitian will be scheduled.
The aim of the study is to determine the optimal dietary model in terms of weight loss and health that would be both acceptable and environmentally friendly dietary model based on limiting the consumption of meat and animal products. The goal of this study is also to evaluate the efficacy of selected plant-based diets on weight loss, effects on selected metabolic and inflammatory parameters in obese adults. Such findings will lead to new knowledge and allow us to formulate new principles for the nutritional treatment of people suffering from obesity.
- Conditions
- Obesity and Overweight, Dietary Intervention, Vegetarian Diet, Vegan Diet, Mediterranean Diet, Metabolic Cardiovascular Syndrome
- Being tested
- Mediterranean diet, Planetary diet, Lactovegetarian diet, Vegan diet, Control diet
- Keywords
- Dietary intervention, plant-based diets, Obesity and overweight, randomised controlled trial
- Medical subject headings
- Obesity, Overweight, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean dietOther
VEGPREV study is a randomized intervention trial with an intervention period of 12 weeks, and follow-up after another 12-14 weeks conducted at the Department of Social Medicine and Public Health at Warsaw Medical University. Study aim is to evaluate the efficacy of the following plant-based diet: Mediterranean diet: Animal : vegetable protein ratio - 70:30.
Planetary dietOther
VEGPREV study is a randomized intervention trial with an intervention period of 12 weeks, and follow-up after another 12-14 weeks conducted at the Department of Social Medicine and Public Health at Warsaw Medical University. Study aim is to evaluate the efficacy of the following plant-based diet: Planetary diet: Reduce consumption of red meat, moderate consumption of poultry, fish and seafood and their products, and eggs and dairy. Animal : vegetable protein ratio - 50:50
Lactovegetarian dietOther
VEGPREV study is a randomized intervention trial with an intervention period of 12 weeks, and follow-up after another 12-14 weeks conducted at the Department of Social Medicine and Public Health at Warsaw Medical University. Study aim is to evaluate the efficacy of the following plant-based diet: Lactovegetarian diet: Reduce consumption of meat, fish and seafood and their preparations, and eggs and dairy products. Animal : vegetable protein ratio - 30:70.
Vegan dietOther
VEGPREV study is a randomized intervention trial with an intervention period of 12 weeks, and follow-up after another 12-14 weeks conducted at the Department of Social Medicine and Public Health at Warsaw Medical University. Study aim is to evaluate the efficacy of the following plant-based diet: Vegan diet: Excludes all animal and animal-derived products (meat, fish, seafood, dairy, eggs, honey).
Control dietOther
VEGPREV study is a randomized intervention trial with an intervention period of 12 weeks, and follow-up after another 12-14 weeks conducted at the Department of Social Medicine and Public Health at Warsaw Medical University. Study aim is to evaluate the efficacy of the following plant-based diet: Control diet: Reduce consumption of red meat, consumption of poultry, fish and seafood and their products, regular consumption of eggs and dairy products.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean diet | Experimental | This heart-healthy eating plan emphasizes healthy fats, whole grains, fruits, vegetables, beans, nuts and seeds. Receives: Other: Mediterranean diet |
| Planetary diet | Experimental | Defined in the EAT-Lancet Commission report Receives: Other: Planetary diet |
| Lactovegetarian diet | Experimental | A variation of vegetarianism that excludes meat, poultry, seafood, and eggs, but includes dairy products. Receives: Other: Lactovegetarian diet |
| Vegan diet | Experimental | Based on plants (such as vegetables, grains, nuts and fruits) and foods made from plants. Receives: Other: Vegan diet |
| Control diet | Experimental | Based on the current national dietary recommendations for the Polish population Receives: Other: Control diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Mean incremental difference in body weight (kg) change of 1% consecutively between each of the five groups (corresponding to an effect size of 0.57)
Measured: After 12 weeks of dietary intervention
Secondary outcomes (10)
Waist and hip circumference
Waist and hip circumference changes in cm.
Measured: After 12 weeks of intervention
Waist-Hip Ratio (WHR)
Waist (in cm) and hip circumference (in cm) will be combined to report WHR changes.
Measured: After 12 weeks of intervention
Body fat mass
Body mass fat expressed in kg and as a percentage of body mass (%) changes.
Measured: After 12 weeks of intervention]
Lipids profile
Evaluation of lipid metabolism changes by: total cholesterol (mg/dl) , LDL - cholesterol (mg/dl), HDL - cholesterol (mg/dl), triacylglycerols (mg/dl) levels.
Measured: After 12 weeks of intervention
Glucose level changes
Assessment of metabolic changes related to glucose regulation by fasting glucose (in mg/dl).
Measured: After 12 weeks of intervention.
Insulin level changes
Assessment of metabolic changes related to glucose regulation by fasting insulin (in μIU/ml) levels.
Measured: After 12 weeks of intervention
Blood Uric Acid
Evaluation of intervention effects on purine metabolism by blood uric acid (mg/dl) level change.
Measured: After 12 weeks of intervention
Serum Micronutrient Levels
Changes in folic acid (ng/ml), ferritin (ng/ml), iron (μg/dl), and vitamin D3 (ng/ml) vitamin B12 (pg/ml) blood concentration to assess alterations in micronutrient levels in response to the intervention.
Measured: After 12 weeks of intervention
Liver Enzymes Activity
Changes in ALT (U/l), AST (U/l), and GGTP (U/l) activity to assess liver function alterations.
Measured: After 12 weeks of intervention
Inflammatory Markers
Changes in levels of CRP (mg/l), IL-6 (pg/mL), IL-18 (pg/mL), IL-1RA (pg/mL), E-selectin (ng/mL), ICAM-1 (ng/mL), MCP-1 (pg/mL), adiponectin (µg/mL), omentin-1 (ng/mL), and resistin (ng/mL) to analyse systemic inflammation responses.
Measured: After 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Oct 2023
- Primary completion5 Aug 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANNA JAGIELSKA, Medical University of Warsaw
- Investigators
- Anna M Jagielska, MD, PhD, Principal investigator, Medical University of Warsaw, Department od Social Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886490
- Sponsor's protocol ID
- KB/37/2023
- Acronym
- VEGPREV
- Status last verified
- Jan 2025
- First submitted
- 18 Feb 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Plant-based Diets on Body Weight and Selected Metabolic Parameters in Obese Patients: a Randomised Controlled Trial of Five Different Diets
- ClinicalTrials.gov ID
- NCT06886490
- Acronym / sponsor ID
- VEGPREV / KB/37/2023
- Conditions
- Obesity and Overweight, Dietary Intervention, Vegetarian Diet, Vegan Diet, Mediterranean Diet, Metabolic Cardiovascular Syndrome
- Keywords
- Dietary intervention, plant-based diets, Obesity and overweight, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 20 Mar 2025 (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.
The aim of the study is to determine the optimal plant-based dietary model in terms of weight loss and health that would be both acceptable and environmentally friendly dietary model based on limiting the consumption of meat and animal products. Such findings will lead to new knowledge and allow us to formulate new principles for the nutritional treatment of people suffering from obesity.
Detailed description
Obesity is not only one of the most serious health problems in the world, it is also associated with an increased risk of many other diseases. Despite many preventive measures, the number of people suffering from obesity is constantly increasing, also in Poland. One of the integral elements of treatment is a change in lifestyle, including a change in eating habits. In this context, new dietary models are constantly being considered and eagerly adopted by patients. These are not always rational and evidence-based choices. What's more, what we eat is not only important for our health, but also for the planet. Recently, high-fat diets with a significant carbon footprint have gained popularity.
It is therefore worth considering more plant-based dietary models in the treatment of obesity and its associated disorders. Such a change can simultaneously help reduce greenhouse gas emissions and improve environmental quality, as well as benefit our health - both directly and indirectly.
There is a growing body of scientific evidence suggesting that limiting meat consumption may be beneficial to health, leading to weight loss, improvements in selected cardiovascular risk parameters and inflammation. However, many questions remain.
For this reason, more plant-based dietary patterns are worth considering in the treatment of obesity and its accompanying disorders. There is growing scientific evidence that limiting meat consumption promotes good health. It has been shown that the implementation of a vegetarian diet can result in weight loss, as well as help in maintaining optimal weight levels more effectively in the long term. This is extremely important for people suffering from obesity. Adherence to meat-restricted diets is also associated with other health benefits, which include an improved lipid profile and other cardiovascular risk parameters, as well as beneficial effects on inflammation and oxidative stress parameters.
Currently, there are only a few intervention studies available that have investigated the effectiveness of plant-based diets in a population of obese adults who previously have not restricted their meat consumption. Most of the studies concern vegetarians, whose awareness of taking care of their diet and lifestyle is, after all, much higher. To some extent, this may explain such optimistic conclusions from observational studies. It is not the only issue associated with research focused on plant-based diets. In experimental studies, the results of dietary interventions are very often compared with no intervention whatsoever. It would therefore be interesting to verify the effectiveness of a vegan or vegetarian diet against current dietary recommendations or another health-promoting dietary pattern - the Mediterranean diet. After all, vegan or vegetarian diets are elimination diets. Should they be recommended for the treatment of obesity and disorders associated with it? Do body weight, cholesterol and glucose levels decrease faster? What risks do they entail and are they difficult to implement? The investigators only know the answers to some of these questions.
In light of the above facts, the study will aim to evaluate the efficacy of the following plant-based diets: (1) the Mediterranean diet, (2) the 'planetary diet' as defined in the EAT-Lancet Commission report (3), the lactovegetarian diet, and (4) the vegan diet, in terms of weight reduction and effects on selected metabolic factors among obese patients. The last group (5) will receive the current national dietary recommendations for the Polish population.
To the investigators best knowledge, this is the first such study in Poland comparing several different plant-based diets. The investigators plan to recruit 100 obese adults under 60 years of age. The cohort will be randomly divided into five groups, each receiving a different intervention for 12 weeks. After 12 to 14 weeks from the end of the intervention, a follow-up meeting will take place again (i.e. after 24 to 26 weeks from the start of the nutritional intervention).
The study collect socio-demographic data and information on lifestyle (including dietary habits, physical activity, substance use and diet supplementation), psychological questionnaires (Perception of their own ability to change their diet (personality resources), which will be determined by the intensity of self-efficacy (GSES scale); Positive attitude towards the future, which will be determined by assessing the intensity of optimism (LOT-R); Coping dealing with emotions, which will be determined by assessing emotional control (CECS emotional control scale); Human ability to respond flexibly to changing situation requirements (stress, conflict, uncertainty), which will be determined by use The Brief Resilience Coping Scale (BRCS) created by V. G. and K. Sinclair A. Wallston) and to carry out biochemical tests and anthropometric measurements. Patients will be given dietary recommendations appropriate to the diet and specially designed dietary schemes, the main element to be intervened upon being the frequency of consumption of meat and other animal products or their elimination. In addition, an average carbon footprint will be estimated for each diet. Meetings with the dietitian will take place in a hybrid format (face-to-face and on-line). Venous blood for biochemical testing will be collected from patients before and after the study and at week 6 of the intervention. At the same time, anthropometric measurements will also be taken and information on wellbeing or difficulties in meeting dietary recommendations will be recorded. The investigators plan to examine the effects of the intervention on changes in body weight, body composition, blood pressure and, among others, changes in total cholesterol, LDL fraction, HDL fraction, changes in triacylglycerols, blood glucose, insulin, reduction in blood uric acid or changes in ALT, AST, GGTP activity.
Also, biochemical tests will be performed, including tests for inflammatory parameters (C-reactive protein (CRP), interleukin-6 (IL-6), L-selectin, intercellular adhesion molecule-1 (ICAM-1), and adiponectin), as well as anthropometric measurements and body composition assessments based on electrical bioimpedance. TMAO concentrations will be examined in relation to selected appetite traits. In addition, metabolites and cofactors of the methionine cycle (S-(5'-Adenosyl)-L-homocysteine (SAH), homocysteine, methionine, S-(5'-Adenosyl)-L-methionine (SAM), choline, betaine) will be monitored. In addition, selected polymorphisms of genes related to the homocysteine-methionine cycle and lipid metabolism will be evaluated. Patients will be given dietary recommendations according to their dietary habits, with the frequency of consumption or elimination of meat and other zoonotic products and their products as the main intervention element. Meetings with the dietitian will be held at baseline, week 6 and week 12. Between meetings, weekly online visits with a psychodietitian will be scheduled.
The aim of the study is to determine the optimal dietary model in terms of weight loss and health that would be both acceptable and environmentally friendly dietary model based on limiting the consumption of meat and animal products. The goal of this study is also to evaluate the efficacy of selected plant-based diets on weight loss, effects on selected metabolic and inflammatory parameters in obese adults. Such findings will lead to new knowledge and allow us to formulate new principles for the nutritional treatment of people suffering from obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Mediterranean diet | Experimental | Other: Mediterranean dietThis heart-healthy eating plan emphasizes healthy fats, whole grains, fruits, vegetables, beans, nuts and seeds. |
| Planetary diet | Experimental | Other: Planetary dietDefined in the EAT-Lancet Commission report |
| Lactovegetarian diet | Experimental | Other: Lactovegetarian dietA variation of vegetarianism that excludes meat, poultry, seafood, and eggs, but includes dairy products. |
| Vegan diet | Experimental | Other: Vegan dietBased on plants (such as vegetables, grains, nuts and fruits) and foods made from plants. |
| Control diet | Experimental | Other: Control dietBased on the current national dietary recommendations for the Polish population |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age >18 years (adults able to give informed consent to participate in the study) ≤ 60 years of age
- BMI >30 kg/m2 or BMI 25-29.9 kg/m2 with waist circumference in women 88 cm, in men 94cm.
Key exclusion criteria (8 listed)
- age <18 years and >60 years,
- severe medical conditions, including alcoholism, major and extensive surgery, chronic kidney and liver disease, history of myocardial infarction, unstable angina pectoris within the last 6 months, history of stroke within the last 6 months, cancer within the last 5 years,
- psychiatric condition preventing participation in the study and cooperation with the investigators,
- use of enteral or parenteral nutrition,
- use of medications that cause significant weight loss (e.g., GLP-1 analogues)
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 |
|---|---|---|
| Mediterranean dietVEGPREV study is a randomized intervention trial with an intervention period of 12 weeks, and follow-up after another 12-14 weeks conducted at the Department of Social Medicine and Public Health at Warsaw Medical University. Study aim is to evaluate the efficacy of the following plant-based diet: Mediterranean diet: Animal : vegetable protein ratio - 70:30. | Other | Mediterranean diet |
| Planetary dietVEGPREV study is a randomized intervention trial with an intervention period of 12 weeks, and follow-up after another 12-14 weeks conducted at the Department of Social Medicine and Public Health at Warsaw Medical University. Study aim is to evaluate the efficacy of the following plant-based diet: Planetary diet: Reduce consumption of red meat, moderate consumption of poultry, fish and seafood and their products, and eggs and dairy. Animal : vegetable protein ratio - 50:50 | Other | Planetary diet |
| Lactovegetarian dietVEGPREV study is a randomized intervention trial with an intervention period of 12 weeks, and follow-up after another 12-14 weeks conducted at the Department of Social Medicine and Public Health at Warsaw Medical University. Study aim is to evaluate the efficacy of the following plant-based diet: Lactovegetarian diet: Reduce consumption of meat, fish and seafood and their preparations, and eggs and dairy products. Animal : vegetable protein ratio - 30:70. | Other | Lactovegetarian diet |
| Vegan dietVEGPREV study is a randomized intervention trial with an intervention period of 12 weeks, and follow-up after another 12-14 weeks conducted at the Department of Social Medicine and Public Health at Warsaw Medical University. Study aim is to evaluate the efficacy of the following plant-based diet: Vegan diet: Excludes all animal and animal-derived products (meat, fish, seafood, dairy, eggs, honey). | Other | Vegan diet |
| Control dietVEGPREV study is a randomized intervention trial with an intervention period of 12 weeks, and follow-up after another 12-14 weeks conducted at the Department of Social Medicine and Public Health at Warsaw Medical University. Study aim is to evaluate the efficacy of the following plant-based diet: Control diet: Reduce consumption of red meat, consumption of poultry, fish and seafood and their products, regular consumption of eggs and dairy products. | Other | Control diet |
Primary outcome
Body weight
Time frame: After 12 weeks of dietary intervention
Mean incremental difference in body weight (kg) change of 1% consecutively between each of the five groups (corresponding to an effect size of 0.57)
10 secondary outcomes
Waist and hip circumference
Time frame: After 12 weeks of intervention
Waist-Hip Ratio (WHR)
Time frame: After 12 weeks of intervention
Body fat mass
Time frame: After 12 weeks of intervention]
Lipids profile
Time frame: After 12 weeks of intervention
Glucose level changes
Time frame: After 12 weeks of intervention.
Insulin level changes
Time frame: After 12 weeks of intervention
Blood Uric Acid
Time frame: After 12 weeks of intervention
Serum Micronutrient Levels
Time frame: After 12 weeks of intervention
Liver Enzymes Activity
Time frame: After 12 weeks of intervention
Inflammatory Markers
Time frame: After 12 weeks of intervention
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 20 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Anna M Jagielska, MD, PhD principal investigator
Medical University of Warsaw, Department od Social Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet, Planetary diet and Lactovegetarian diet in people with Obesity and Overweight and Dietary Intervention, run by Medical University of Warsaw at 1 site in Poland.
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 2 inclusion and 8 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 20 Mar 2025. 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 Poland. 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?
Body weight (time frame: After 12 weeks of dietary intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2025.