Plant-based Diets and Body Weight and Selected Metabolic Parameters Management in Obese Patients.

NCT06886490 | Completed

• 1 other identifier: KB/37/2023
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Dietary intervention; plant-based diets; Obesity and overweight; randomised controlled trial

Outcome Measures

Primary Outcomes (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)

  After 12 weeks of dietary intervention

Secondary Outcomes (10)

• Waist and hip circumference

  After 12 weeks of intervention

• Waist-Hip Ratio (WHR)

  After 12 weeks of intervention

• Body fat mass

  After 12 weeks of intervention]

• Lipids profile

  After 12 weeks of intervention

• Glucose level changes

  After 12 weeks of intervention.

Other Outcomes (1)

• Methionine cycle metabolites and related compounds and Choline pathway metabolites.

  After 12 weeks of intervention

Study Arms (5)

Mediterranean diet

EXPERIMENTAL

This heart-healthy eating plan emphasizes healthy fats, whole grains, fruits, vegetables, beans, nuts and seeds.

Other: Mediterranean diet

Planetary diet

EXPERIMENTAL

Defined in the EAT-Lancet Commission report

Other: Planetary diet

Lactovegetarian diet

EXPERIMENTAL

A variation of vegetarianism that excludes meat, poultry, seafood, and eggs, but includes dairy products.

Other: Lactovegetarian diet

Vegan diet

EXPERIMENTAL

Based on plants (such as vegetables, grains, nuts and fruits) and foods made from plants.

Other: Vegan diet

Control diet

EXPERIMENTAL

Based on the current national dietary recommendations for the Polish population

Other: Control diet

Interventions

Mediterranean diet OTHER

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.

Mediterranean diet

Planetary diet OTHER

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

Planetary diet

Lactovegetarian diet OTHER

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.

Lactovegetarian diet

Vegan diet OTHER

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).

Vegan diet

Control diet OTHER

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.

Control diet

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Social Medicine and Public Health, Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-106, Poland

Location

MeSH Terms

Conditions

Obesity; Overweight; Metabolic Syndrome

Interventions

Diet, Mediterranean; Diet, Vegetarian; Diet, Vegan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Anna M Jagielska, MD, PhD

  Medical University of Warsaw, Department od Social Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 20, 2025
• Study Start: October 1, 2023
• Primary Completion: August 5, 2024
• Study Completion: December 18, 2024
• Last Updated: March 20, 2025

Record last verified: 2025-01

Locations

PL (1)