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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Poland

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.

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 groups in NCT06886490
Study groupRoleWhat they receive
Mediterranean dietExperimentalThis heart-healthy eating plan emphasizes healthy fats, whole grains, fruits, vegetables, beans, nuts and seeds.
Receives: Other: Mediterranean diet
Planetary dietExperimentalDefined in the EAT-Lancet Commission report
Receives: Other: Planetary diet
Lactovegetarian dietExperimentalA variation of vegetarianism that excludes meat, poultry, seafood, and eggs, but includes dairy products.
Receives: Other: Lactovegetarian diet
Vegan dietExperimentalBased on plants (such as vegetables, grains, nuts and fruits) and foods made from plants.
Receives: Other: Vegan diet
Control dietExperimentalBased 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.

  1. 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)
  1. Waist and hip circumference

    Waist and hip circumference changes in cm.

    Measured: After 12 weeks of intervention

  2. 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

  3. Body fat mass

    Body mass fat expressed in kg and as a percentage of body mass (%) changes.

    Measured: After 12 weeks of intervention]

  4. 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

  5. Glucose level changes

    Assessment of metabolic changes related to glucose regulation by fasting glucose (in mg/dl).

    Measured: After 12 weeks of intervention.

  6. Insulin level changes

    Assessment of metabolic changes related to glucose regulation by fasting insulin (in μIU/ml) levels.

    Measured: After 12 weeks of intervention

  7. Blood Uric Acid

    Evaluation of intervention effects on purine metabolism by blood uric acid (mg/dl) level change.

    Measured: After 12 weeks of intervention

  8. 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

  9. 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

  10. 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.

  1. First posted20 Mar 2025
  2. Study start1 Oct 2023
  3. Primary completion5 Aug 2024
  4. Study completion18 Dec 2024

Resources

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)
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

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.

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